Detailed Design Specification for the NASU Chemical ...
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Detailed Design Specification for the Point-of-Care Bedside Bar Code Verification System
Document ID: Detailed Design Specs.doc
PharmaSys Hospital Solutions
Cary, North Carolina
eMEDS PoC Bedside Barcode Verification System
Date: 6-Jan-07
Prepared by:
PharmaSys Hospital Solutions
This document is the property of
PharmaSys Hospital Solutions
APPROVALS
|Author: |
| |
|Signature: ______________________________________ Date: ________ |
| |
|Signature by the Author, for all computer system engineering activities, indicates agreement and commitment to quality actions which |
|assure: |
|1. The correctness, accuracy, reliability, and completeness of the data contained within this document. |
| |
|Developer/Installer: |
| |
|Signature: ______________________________________ Date: ________ |
| |
|Signature by the primary Merck personnel responsible, for all computer system engineering activities, indicates agreement and commitment to|
|quality actions which assure: |
|The correctness, accuracy, reliability, and robustness of the system. |
|Formal methodologies and written technical standards, guidelines & procedures for development and maintenance of the system are |
|established. |
|Documentation for the development, testing and maintenance of the system. |
| |
|System Owner: |
| |
|Signature: ______________________________________ Date: ________ |
| |
|Signature by the primary Merck personnel responsible, for operations using system, indicates agreement and commitment to quality elements |
|which affect the correctness and accuracy of the business area requirements of the system as it relates to the total operating environment.|
|System Administrator: |
| |
|Signature: ______________________________________ Date: ________ |
| |
|Signature by the System Administrator, for all computer system administration activities, indicates agreement and commitment to quality |
|actions which assure: |
|1. The maintainability and the required functionality of the system. |
| |
|Quality Assurance: |
| |
|Signature: ______________________________________ Date: ________ |
| |
|Computer Validation: |
| |
|Signature: ______________________________________ Date: ________ |
| |
|Signature by the primary Merck personnel responsible, for system quality issues and validation, indicate agreement and commitment to |
|quality elements which affect the development and maintenance of the system as guided by approved methodologies and established technical |
|standards guidelines and procedures. |
|See also SOP 480-163 Review and Approval Responsibilities of Computer Validation Documentation |
Publication Record
|REVISION |DESCRIPTION |AUTHOR |DATE |
|0.1 |INITIAL DRAFT, NOT ROUTED FOR REVIEW |PROJECT20PERCENT DESIGN TEAM |03-JAN-06 |
TABLE OF CONTEnts
1. OVERVIEW 6
1.1 Purpose of system 6
1.2 Acronyms 6
1.3 System Architecture 6
1.4 Subsystem Definitions 7
1.5 Data Definitions 7
1.6 Operating Scenario 8
1.7 backup and recovery 9
1.8 critical design considerations 9
1.9 Assumptions 10
2. Hardware 10
2.1 Hardware Resource Analysis 10
2.2 hardware description and target configuration 10
2.2.1 Data Server Error! Bookmark not defined.
2.2.2 Workstations 11
3. General Software 11
3.1 Operational System Software Environment 11
3.1.1 Database Server 11
3.1.2 Application Server 11
3.1.3 Workstations 11
3.2 Application Enablers 11
3.2.1 Database 11
3.2.2 CISPRO 11
3.3 Libraries 11
3.4 Programming Environment 11
3.5 Security 11
3.5.1 Login 11
3.5.2 Password 11
3.5.3 Container Level Security 11
3.5.4 Field Level Security 11
3.5.5 Security levels 11
3.5.6 Auditing 11
3.5.7 Expired usage 11
3.5.8 Data integrity 11
3.6 21 CFR Part 11 Requirements 11
3.6.1 Electronic Signature 11
3.6.2 Electronic Records 11
4. Subsystems Design 11
4.1 Inputs and Outputs 11
4.1.1 User Input Information 11
4.1.2 Reports 11
5. Data 11
5.1 Data Dictionary 11
5.2 Data Archiving 11
6. Limitations and Expandability 11
6.1 System Limitations 11
6.2 Mass Memory Space 11
6.3 System Expandability 11
7. Documentation 11
7.1 References and Standards 11
7.1.1 Internal Merck & Co., Inc. SOPs and Guidelines 11
7.1.2 External / Vendor Supplied Documentation 11
7.2 Modifications to the Detail design Specification 11
Appendix 1 – Data Definitions 11
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Appendix 2 – eMEDS Deployment Protocol 11
Appendix 3 - Network Diagram 11
Overview
1 Purpose of the eMEDS system
About 1.5 billion dollars is lost every year due to improper administration of medications. Our system, eMEDS scans the bar codes of the patient, drug, and nurse in order to correctly match the three to known doctor's orders. This will significantly reduce the number of errors in hospital drug administration, resulting in fewer adverse reactions and loss of life.
2 Acronyms
The acronyms listed below are for use in COMPANY documents:
P/N Part Number
MSDS Manufacturers Safety Data Sheet
CFR Code of Federal Regulations
FDA Food and Drug Administration
JCAHO Joint Commission on Accreditation of Healthcare Organizations
GUI Graphical User Interface
FRS Functional Requirements Specification
ID Identification / Identifier
LAN Local Area Network
PC Personal Computer
QA Quality Assurance
QS Quality System
SOP Standard Operating Procedure
3 System Architecture
The centerpiece of eMEDS is the barcode scanner. It scans three different barcodes that link to patient records, nurse information, and drug databases through a wireless network.
See Figure 1 for the eMEDS system architecture diagram.
[pic]
Figure 1: eMEDS System Architecture
4 Subsystem Definitions
5 Data Definitions
Data retained by the eMEDS system includes the following:
• Medication Information
Inventory ID Number
Identity
Dosage
• Nurse Information
• Patient Information
ID Number
Name
Medications prescribed
6 Operating Scenario
The eMEDS Point-of-Care Bedside Barcode Verification System reads previously encoded information regarding the nurse, patient, and drug and then ensures that the correct transaction occurs at the correct time. url_IPS/IPS/2222_Input.htm
The inputs are 3 barcode scans: patient, drug, and nurse. Also, the time and dosage are recorded. The doctor's orders are considered a previous input to the system for cross-checking. url_IPS/IPS/2223_Output.htm
A "proceed" or "halt" instructs the nurse to either administer the drug or not. This determination is based on the cross-checking of the inputs.
The eMEDS barcode Verification System will be utilized to:
▪ scan nurse wrist band, patient wrist band, and single-dose medication prior to administration
▪ interface with ADT systems to autofill the following patient information fields:
▪ medication
▪ date/time
▪ dosing size and units
▪ administering nurse's name
▪ room #
▪ dose # of total doses to be administered (e.g. dose 4 of 15)
▪ interface with the following hospital systems:
▪ finance/cost accounting
▪ drug inventory
▪ laboratory information
▪ personnel system
▪ pharmacy information
▪ electronic prescription system
▪ clearly alert nurse visually and aurally when there is a medication/patient mismatch
▪ send an automatic alert to defined recipients at the time of a medication/patient mismatch (e.g. email, pagers, cell text messages)
▪ track the following medication/patient mismatch data:
▪ administering nurse
▪ patient
▪ date/time of mismatch
▪ medication thwarted for delivery
▪ room #
▪ reconcile the amount of medication administered vs. amount prescribed in real time
▪ make comments on the patient's medical record
▪ generate labels and wristbands containing barcodes and the following information:
▪ patient ID
▪ patient name
▪ patient telephone
▪ admittance date
▪ view information within the other hospitals systems without need for launching other applications
▪ send relevant data to PharmaSys
The typical operating scenario involves a patient being admitted into a hospital and having a doctor check him out. The physician prescribes certain medications and enters them into the patient's record.
Later on, when the medications are to be administered, the nurse must scan his/her badge, the barcode on the drug, and the patient's barcode. The information from these three barcode scans is cross-checked against the doctor's orders. If everything matches up, the scanner displays a "proceed" order. If there is a mismatch at any point, the scanner displays a "do not proceed" order. All directives are documented for future reference.
7 backup and recovery
The verification system will have the ability to produce hard copies of patient information, nurse and drug history, and doctor orders. Because the system pulls information from existing databases, it will not be considered liable for the loss of information in any certain database. If, for instance, the personnel file for a certain nurse is lost in the database, blame will not fall on the verification system. The hospital itself is responsible for backing up important patient, nurse and drug information.
The only data that will be created from the eMEDS system are the following:
1. Comments on patient records
2. Accountability record
a. Nurse administration history (successes/failures)
b. Medication frequency (prescriptions per day/week/etc.)
The nurse administration history would be used to track nurses who fail to perform up to standard, i.e. those that frequently make bedside mistakes. Data collection in this area would be entirely voluntary. Optimally, the nurse administration history would be appended to the existing personnel database. Again, the verification system would not be held responsible for the loss of this data once it is registered in the personnel database. The medication information is slated to be sent to Company Name Here in Cary, North Carolina for purposes of record-keeping only. This information would be of interest in drug studies pertaining to the decline or increase in a drug's use. Again, the hospital would have to agree to this before collection began.
8 critical design considerations
PDA
|Hours of continuous operation |
|WLAN (wireless local area network) |
|Size of Display |
|Water proof / Environmental sealing |
|Volume (Length x Width x Height) |
|Weight |
|Best drop specifications |
|Microprocessor speed |
|Memory |
|USB port included |
|Speakers (present on model) |
|Cost |
The program must provide information in a form that is easy to view and legible to the caregiver.
9 Assumptions
It will be assumed that the hospital is WIFI-enabled.
Also, we are assuming that all nurse badges contain an identifying barcode and that the medications are packaged/barcoded in unit-doses. The 12-digit bar code number is assumed to encode for the drug's identity, strength, and _______. (ask Alex)
Hardware
1 Hardware Resource Analysis
The eMEDS barcode verification system utilizes a two tier client/server architecture whereby data is stored on separate database servers and the application is stored on a handheld PDA equipped with a barcode scanner. The first tier consists of multiple databases within the hospital, including (but not limited to) patient records, accounting, personnel, laboratory results, and pharmacy information. The second tier, the PDA, uses its own processor and memory to perform the data gathering and cross checks.
2 hardware description and target configuration
1 Barcode Scanner
The eMEDS system is configured for use of portable terminals/barcode scanners. The two portable terminal/barcode scanner types are:
• Symbol MC70
• Symbol MC50
• Intermec CN3
2.2.1.1 Symbol MC70
| |Symbol MC70 |
|Assumed/Required | |
|Multicolor display |Transflective color 3.5” QVGA with backlight, |
| |TFT-LCD, 65K colors, 240 W x 320 L (QVGA size) |
|Alpha keypad |26 Numeric key; 44 QWERTY key |
|1-D scanner |SE800HP 1D Linear Scanner |
|Windows OS |Microsoft® Windows™ Mobile 5.0 Premium, & Phone Edition |
|Sufficient memory |64MB RAM/128MB ROM MORE ROM |
|Sufficiently fast processor |Intel® XScale™ 624 Mhz processor FASTER |
|WLAN capabilities |Tri-mode IEEE® 802.11a/b/g |
|Speaker(s) |Yes |
|USB port |RS-232, USB 1.1 |
|Defining Options | |
|Physical | |
|Dimensions |6 in. L x 3 in. W x 1.5 in H |
| |15.3 cm L x 7.6 cm W x 3.7 cm H |
|Weight |LAN/PAN configurations - 11.2 oz./314 g |
| |WAN/LAN/PAN configurations - 12 oz./336 g |
|Display Size |3.5" |
|Touchscreen |Glass analog resistive touch |
|Battery | |
|Main Battery |Lithium Ion 3.7V, 1900 mAh Smart Battery |
|Standard Capacity Battery |Lithium Ion 3.7V, 1900 mAh Smart Battery |
|Extended Capacity Battery |Optional 3.7V, 3800 mAh Smart Battery |
|Backup Battery |Ni-MH battery (rechargeable) 1.2V, 2 cells (not user-accesible) |
|System | |
|CPU |Intel® XScale™ 624 Mhz processor |
|Operating System |Microsoft® Windows™ Mobile 5.0 Premium, & Phone Edition |
|Memory |64MB RAM/128MB ROM |
|User Environment | |
|Humidity |95% non-condensing |
|Drop Specifications |4 ft. drop to concrete, 6 drops per 6 sides over operating |
| |temperature range; 5 ft. drop to concrete, 2 drops per 6 sides |
| |at ambient temperature 73° F/23° C |
|Tumble Specifications |1,000 1.6 ft./.5 m tumbles (2,000 drops) |
|WLAN Options | |
|Data Rates Supported |1, 2, 5.5, 6, 9, 11, 12, 18, 24, 36, 48 and 54 Mbps |
|Operating Channels |Chan 8-169 (5040 – 5845 MHz) |
| |Chan 1-13 (2412-2472 MHz) |
| |Actual operating frequencies depend on regulatory |
| |rules and certification agency |
|Security |WEP (40 or 128 bit), TKIP, TLS, TTLS (MS-CHAP), |
| |TTLS (MS-CHAP v2), TTLS (CHAP), TTLS-MD5, TTLS-PAP, |
| |PEAP-TLS, PEAP (MS-CHAP v2), AES, LEAP |
|2-D scanner | |
|2D Imager |SE440 2D Imager Engine |
|Non-Defining Options | |
|Physical | |
|Expansion Slot |User accessible SDIO slot (with secure cover); |
|Vibrate Mode |No |
|Audio |Speaker, receiver, microphone, headset jack, |
|Headphone Jack |software support for full duplex record and playback (stereo) |
|Microphone | |
|System | |
|Memory Extension |No |
|Speech Recognition Software |No |
|GPS |No |
|User Environment | |
|Operating Temperature |14°F to 122° F/-10°C to 50° C |
|Storage Temperature |-40° F to 140° F/-40° C to 60° C |
|Electrostatic Dischrage (ESD) |+/-15kV air discharge, +/-8kV direct discharge |
|Network Connections | |
|Hardwire port |No |
|WWAN |eGPRS/GSM (850, 900, 1800 and 1900 MHz) |
|WPAN |Bluetooth Class II, v1.2 |
|WLAN Options | |
|Spreading Technique |Direct Sequence Spread Spectrum (DSSS) |
| |and Orthogonal Frequency Division Multiplexing (OFDM) |
|Antenna |Internal for LAN, External for WAN |
|Voice Communication (VoIP) |Integrated Voice-over-IP ready (P2P, PBX, PTT), Wi-Fi™-certified, |
| |IEEE 802.11a/b/g direct sequence wireless LAN |
|2-D scanner options | |
|Field of View |Horizontal - 32.2°, Vertical - 24.5° |
|Optical Resolution (gray scale) |640 H x 480 V pixels (gray scale) |
|Roll |360° |
|Pitch Angle |+/- 60° from normal |
|Skew Tolerance |+/- 50° from normal |
|Focal Dist. from Front of Engine |Near: 5 inches, Far: 9 inches |
|Aiming Element (VLD) |650 nm +/- 5 nm |
|Illumination Element (LED) |635 nm +/- 20 nm |
|Ambient Light |Total darkness to 9,000 ft. candles (96,900Lux) |
|Shock |2,000 +/- 5% G |
|Minimum Print Contrast |Minimum 25% absolute dark/light reflectance measured at 650 nm |
|1-D scanner | |
|Optical Resolution |0.005 in. minimum element width |
|View Angle |? |
|Pitch Angle |+/- 65° from normal |
|Roll |+/- 30° from vertical |
|Skew Tolerance |+/- 60° from normal |
|Ambient Light |Sunlight: 8,000 ft. candles (86,112Lux) |
|Artificial Light |450 ft. candles (4,844Lux) |
|Shock |2,000 +/- 5% G |
|Scan Rate |50 (+/-6) scans/sec (bidirectional) |
|Scan Angle |46.5° (typical) |
|Depth of Field |? |
|Laser Power |1.0 mW nominal |
|Peripherals and Accessories | |
|Battery Chargers |4-slot battery charger (1X and 2X), universal battery charger |
| |(requires adapters for 1X and 2X capacity batteries) |
|Comm. and Charging Cables |Serial and USB v1.1 charging cables, printer cables, vehicle |
| |charging cable, power/charging cable |
|Cradels |Single-slot serial/USB with spare battery charging for standard |
| |and extended batteries, four-slot Ethernet cradle, vehicle cradle |
|Printers |None |
|Vertical-specific attachments |Snap-on magnetic stripe reader, snap-on trigger handle, rigid case |
|Regulatory | |
|Electrical Safety |to UL / cUL 60950-1, IEC / EN60950-1 |
|EMI/RFI |North America: FCC Part 15 |
|Hazardous Locations |? |
|Laser Safety |IEC Class2/FDA Class II in accordance with IEC60825-1/EN60825-1 |
|Quad Band eGPRS / GSM |Global: 3GPP TS 51.010, GCF approved module |
| |USA: FCC Part 22 , Part 24 |
|WLAN and Bluetooth |USA: FCC Part 15.247, 15.407 |
[pic]
Figure 2: Symbol MC70
2.2.1.2 Symbol MC50
| |Symbol MC50 |
|Assumed/Required | |
|Multicolor display |Transflective color TFT-LCD, 65K colors, |
| |240 (W) x 320 (L) (QVGA size) |
|Alpha keypad |QWERTY: 37-key |
|1-D scanner |CSE600 CMOS Imager |
|Windows OS |Microsoft® Windows Mobile™ 2003 Second Edition |
|Sufficient memory |64MB RAM/ 64MB ROM |
|Sufficiently fast processor |Intel® XScale™ 520 Mhz processor |
|WLAN capabilities |IEEE® 802.11b |
|Speaker(s) |Yes |
|USB port |RS-232, USB 1.1 |
|Defining Options | |
|Physical | |
|Dimensions |1D: 5.35 in. H x 2.95 in. W x .94 in. L |
| |2D Imager: 5.35 in. H x 2.95 in. W x 1.13 in. L |
|Weight |QWERTY 1D: 6.77 oz/ 192 g |
|Display Size |3.5" |
|Touchscreen |Glass analog resistive touch |
|Battery | |
|Main Battery |Rechargeable Lithium Ion 3.7V, 1560 mAh |
|Standard Capacity Battery |Rechargeable Lithium Ion 3.7V, 1560 mAh |
|Extended Capacity Battery |Optional 3.7V, 3600 mAh |
|Backup Battery |Ni-MH battery (rechargeable) 15mAh 1.2V, 1 cell |
|Battery Life | |
|System | |
|CPU |Intel® XScale™ 520 Mhz processor |
|Operating System |Microsoft® Windows Mobile™ 2003 Second Edition |
|Memory |64MB RAM/ 64MB ROM |
|User Environment | |
|Humidity |95% non-condensing |
|Drop Specifications |3' drop to tile over concrete, 1 drop per side at 21° C ( 70° F) |
|Tumble Specifications |None given |
|WLAN Options | |
|Data Rates Supported |1/2/5.5/11 Mbps |
|Security |WEP, TKIP, LEAP, PEAP, EAP-TLS, WPA (pre-shared key) |
|2-D scanner | |
|2D Imager |SE440 2D Imager Engine |
|1-D scanner | |
|Supported Symbologies |UPC /EAN, Code 39, I 2 of 5, Discrete 2 of 5, Code 128, |
| | UCC.EAN128, Code 93, Codabar |
|Non-Defining Options | |
|Physical | |
|Expansion Slot |User accessible SDIO slot (with secure cover) |
|Vibrate Mode |No |
|Audio | |
|Headphone Jack |Speaker, receiver, microphone, headset jack |
|Microphone |Software support for full duplex record and playback (stereo) |
|System | |
|Memory Extension |No |
|Speech Recognition Software |No |
|GPS |No |
|User Environment | |
|Operating Temperature |0° to 50° C (32° to 155° F) |
|Storage Temperature |-25° to 60° C (-13° to 140° F) |
|Electrostatic Dischrage (ESD) |+/-8kV air discharge, +/-8kV direct discharge |
|Network Connections | |
|Hardwire port |No |
|WWAN |No |
|WPAN |No |
|WLAN Options | |
|Spreading Technique |Direct sequence |
|Antenna |Internal |
|Voice Communication (VoIP) |Integrated Voice-over-IP ready (P2P, PBX, PTT) |
| |Wi-Fi™-certified, IEEE 802.11b direct sequence wireless LAN |
|2-D scanner options | |
|Field of View |Horizontal: 32.2°, Vertical: 24.5° |
|Optical Resolution (gray scale) |640 (H) x 480 (V) pixels |
|Roll |360° |
|Pitch Angle |+/- 60° from normal |
|Skew Tolerance |+/- 50° from normal |
|Focal Dist. from Front of Engine |Near: 5 inches, Far: 9 inches |
|Aiming Element (VLD) |650 nm +/- 5 nm |
|Illumination Element (LED) |635 nm +/- 20 nm |
|Ambient Light |Total darkness to 9,000 ft. candles (96,900Lux) |
|Shock |2,000 +/- 5% G |
|1-D scanner | |
|Optical Resolution |0.005 in. minimum element width |
|Pitch Angle |+/- 65° from normal |
|Roll |+/- 30° from vertical |
|Skew Tolerance |+/- 60° from normal |
|Ambient Light |Sunlight: 8,000 ft. candles (86,112Lux) |
|Artificial Light |450 ft. candles (4,844Lux) |
|Shock |2,000 +/- 5% G |
|Scan Rate |50 (+/-6) scans/sec (bidirectional) |
|Scan Angle |46.5° (typical) |
|Laser Power |1.0 mW nominal |
|Camera & Camera Options |Available (choose 1D, 2D, OR Camera) |
|Peripherals and Accessories | |
|Battery Chargers |4-slot battery charger (1X and 2X), universal battery charger |
| |(requires adapters for 1X and 2X capacity batteries) |
|Comm. and Charging Cables |USB v1.1, vehicle charging cable, power/charging cable |
|Cradles |Single-slot serial/USB with spare battery charging for standard |
| |& extended batteries, 4-slot Ethernet cradle, vehicle cradle |
|Printers |No |
|Vertical-specific attachments |Snap-on magnetic stripe reader, universal |
| |cable cup adapter attachable cables |
|Regulatory | |
|Electrical Safety |UL60950, CSA C22.2 No. 60950, EN60950/IEC 950 |
|EMI/RFI |Yes |
|Hazardous Locations |? |
|Laser Safety |IEC Class2/FDA Class II in acc. w/ IEC60825-1/EN60825-1 |
[pic]
Figure 3: Symbol MC50
2.2.1.3 Intermec CN3
| |Intermec CN3 |
|Assumed/Required | |
|Multicolor display |3.5 in (89 mm) QVGA (240 x 320 pixel) |
| |64K color Transflective TFT-LCD, LED backlight |
|Alpha keypad |QWERTY or Numeric backlit keypad |
|1-D scanner |Integrated area imager: supports omnidirectional 1D, 2D, |
| |& composite decode capabilities |
|Windows OS |Windows Mobile 5.0® |
|Sufficient memory |128MB and Flash ROM 128MB |
|Sufficiently fast processor |Intel® XScale PXA270, 520 MHz |
|WLAN capabilities |(802.11 & Bluetooth® standard) 802.11b/g (pending) Bluetooth Class 2, |
| |V2.0, GSM/GPRS/EDGE, CDMA/1XRTT/EV-DO, |
| |GPS: Network-ind. embedded receiver |
|Speaker(s) |Dual Speakers |
|USB port |USB 1.1 Host and Client |
|Defining Options | |
|Physical | |
|Dimensions |Dimensions with Standard Battery Pack: 6.3 x 3.2 x 1.1 in |
| |Dimensions with Extended Battery Pack: 6.3 x 3.2 x 1.3 in |
|Weight |397-454 g (14.0 oz - 16.0 oz) |
|Display Size |3.5 in (89 mm) QVGA (240 x 320 pixel) |
|Touchscreen |No |
|Battery | |
|Main Battery |Lithium-Ion 3.7V, 2200 mAh |
|Standard Capacity Battery |3.7V, 2200 mAh, (8.1 Watt-hour) Li-Ion |
|Extended Capacity Battery |3.7V, 4000 mAh, (14.8 Watt-hour) Li-Ion |
|Backup Battery |N/A |
|Battery Life |8.1 or 14.8 Watt-hours |
|System | |
|CPU |Intel® XScale PXA270, 520 MHz |
|Operating System |Windows Mobile 5.0® |
|Memory |128MB and Flash ROM 128MB |
|User Environment | |
|Humidity |95% relative humidity |
|Drop Specifications | 26x all faces, sides from 1.2 m (4 ft) |
|WLAN Options |(802.11 & Bluetooth® standard) 802.11b/g (pending) Bluetooth Class 2, |
|Security |WPA, 802.11i (WPA2), WEP, TKIP, TLS, TTLS, AES, PEAP, LEAP, MD5 |
|2-D scanner | |
|2D Imager |Integrated area imager |
|Non-Defining Options | |
|Physical | |
|Expansion Slot |No |
|Vibrate Mode |No |
|Audio | |
|Headphone Jack |Wireless Bluetooth headset support |
|Microphone |Yes |
|System | |
|Memory Extension |Customer-accessible miniSD slot for removable memory cards up to 2GB. |
|Speech Recognition Software |Yes |
|GPS |Yes: Network independent embedded receiver with integrated antenna |
|User Environment | |
|Operating Temperature | -10°C to +50°C (+14°F to +122°F) |
|Storage Temperature | -20°C to +70°C (-4° F to +158°F) |
|Electrostatic Dischrage (ESD) |+/- 15 kVdc air discharge, +/- 8 kVdc contact discharge |
|Network Connections | |
|Hardwire port |No |
|WWAN |V2.0, GSM/GPRS/EDGE, CDMA/1XRTT/EV-DO, |
| |GPS: Network-ind. embedded receiver |
|WPAN |(802.11 & Bluetooth® standard) 802.11b/g (pending) Bluetooth Class 2, |
|Voice Communication (VoIP) |Yes |
|Camera & Camera Options |1.3 megapixel color camera with LED flash |
|Peripherals and Accessories | |
|Battery Chargers |Yes |
|Cradels |Yes |
[pic]
Figure 4: Intermec CN3
2 Servers
The eMEDS system is configured to communicate with multiple servers. The three main ones are the personnel database, the hospital's pharmacy database, and the patient database. Additionally, the eMEDS system will be able to communicate with the server containing the doctor's orders. All servers will be housed by the hospital and will be already in place once the verification system is implemented.
1 Computers
Will desktop computers at nurse workstations be an integral part of this system?
2.2.2.3 Label Printers
The system will utilize Intermec barcode label printers.
Printer Specifications:
General Software
The eMEDS software is an integral component of the verification system. At the heart of the software is a graphical user interface (GUI) that was created in Microsoft Form Creator (?).
1 Operational System Software Environment
1 Database Server
The database server utilizes the HP-UX operating system.
2 Application Server
The NASU Chemical Inventory System (CISPRO) application server utilizes the Windows NT 4.x operating system.
3 Workstations
The NASU Chemical Inventory System (CISPRO) workstations utilize Windows NT 4.x operating systems with Service Pack 6a.
2 Application Enablers
1 Database
The NASU Chemical Inventory System (CISPRO) shall utilize Oracle 8.7.1 as installed on server WLNASU01. Tables are installed by running scripts included in Appendix 1 – Data Definitions and installed per Appendix 2 – Deployment Protocol.
2 CISPRO
The NASU Chemical Inventory System (CISPRO) utilizes CISPRO 2000 for Oracle, Version 4.13.19, an off-the-shelf software package as the major application.
3 Libraries
As an Off-the-Shelf application, the NASU Chemical Inventory System (CISPRO) source code and/or libraries are not needed or available.
4 Programming Environment
The NASU Chemical Inventory System (CISPRO) is a commercially available system developed by ChemSW, Inc. Development of this application was conducted in a controlled, development environment. No customization of the system is necessary. It is installed in the production environment and qualified prior to use.
5 Security
1 Login
A user’s network login provides the initial security level for the CISPRO system, as they will need to have an active user ID and submit a valid network password to gain access to any computer system. Password entry will be in an encrypted format so that it is not visible to users or the System Administrator. Once users are successfully logged onto the network, only those users who have entered their active user ID and password for the CISPRO system are allowed access.
2 Password
A minimum password length of eight characters is assigned by the CISPRO system administrator, and passwords can be changed by each individual user at-will or when their current password expires. The System Administrator can also de-activate a user account, or modify user privileges when necessary. Unauthorized access is prohibited.
3 Container Level Security
The Client/Server (C/S) version of CISPRO has an advanced security feature called "user container security". Basically this feature prevents users from modifying containers for which they do not have responsibility. One can enable this feature by going into File | Configure | Customize tab, and checking the "User Container Security" option.
With this option enabled, the logon user can only modify, delete or change quantity on containers that are assigned their user name in the Responsible field of the container. Note that there are two additional access level permissions so that you can create "higher" levels of access.
For example, you might have a "GroupManager" access level, who should be able to manage containers for anyone in their department. In that case you can check the "Allow access to all users in department" permission in the Access Level dialog. There is also an "Allow access to all departments" permission which would allow access to any container (typically for administrators).
In order to use this feature effectively, you will need to perform some initial setup. All of the following steps work together to make sure User Container Security works in a logical fashion.
Steps to configure User Container Security
1) Create a list of Departments, using View | Departments
2) Create a list of Locations (use View | Locations) and assign each Location to a department
3) Create a set of Access Levels (use Levels... button from the User Accounts dialog) with proper permissions for various types of users
4) Create a list of User Accounts (use File | Configure and the Setup... button), and be sure to assign an AccessLevel and a Department to each user.
5) Add containers for each user, setting the Responsible field to the correct user name (logon) for the allowed user of that container.
Once this is done, one can enable User Container Security in File | Configure | Customize tab, and also Enable Security in File | Configure | Defaults tab.
From this point on, users can only access containers for which they are authorized.
4 Field Level Security
Client/Server versions of CISPRO 2000 provide field level access control for all fields in the MAIN and BATCH tables. Note that in some cases you may configure access control such that it interferes with other features of CISPRO 2000. You are encouraged to seek technical support assistance when configuring this feature.
Basically, field level access means that for any field in MAIN or BATCH, you can specify whether a particular Access Level has read-only or read/write access to that field. An example will probably help here. Consider the following scenario. You would like to change the UserCheck1 check box field on the Identity tab so it is labeled "TSCA Chemical". This will be used as a flag for various reports, so most users should not be allowed to change it.
What we can do is define a new Access Level named "DefaultFieldAccess" that has this field set to read only. Then, whenever a user logs on without explicit read/write permission to this field, it will be marked read-only for them.
5 Security levels
Administrator, Update, Limited Update, and Inquiry security levels are provided, and may be modified only by the system administrator. While the system administrator will have full access to the system, ordinary users have access to the following:
• Change quantity of, add, modify, delete, dispose, and define Containers.
• Add, delete, modify, and define Properties.
• View and modify Ingredients.
• Add, delete, and modify Main Records.
In addition, the system administrator can modify the system configuration, while users may only view the current configuration.
7 Auditing
The CISPRO system provides a means of comprehensive auditing operator usage that is not capable of being altered or deleted. The audit trail operates in the background, and does not require any user input. Audit trail data includes operator name, and server date/time information for all operations that cannot be altered. All logins, successful or not, are monitored by the CISPRO audit trail. Realtime login events are viewable.
8 Expired usage
Inactive users or staff of the CISPRO system may only be marked “inactive”, and cannot be entirely deleted from the system, though they may be reactivated at a later date only by a system administrator and only when a new password has been assigned.
9 Data integrity
Users are not permitted to alter or in any way change system commands or the software code. Only the system administrator is allowed to review and modify user privileges and access profiles.
6 21 CFR Part 11 Requirements
The CISPRO system meets 21 CFR Part 11 requirements for a “closed” system. In addition, the system is capable of: discerning invalid or altered records; storing records for future review and retrieval; providing a clear and secure audit trail; verifying authorized users during login; assigning various incremental security levels for all users.
1 Electronic Signature
For 21 CFR Part 11 compliancy, CISPRO 2000 has an available optional version called eSig (Electronic Signature). The eSig version provides advanced security features, and a secure, date-time stamped audit trail.
1 Security Manager (DIDMGR) Program
When using the eSig version of CISPRO 2000, several of the security data fields are stored in a separate schema. These items are:
• user names
• passwords
• account expirations
• account enables
• user identity information
• Digital IDs
The schema which contains these additional fields should be tightly controlled by the system administrator.
The following security restrictions apply under eSig:
1) All security account information is controlled by the DIDMGR program, not from CISPRO 2000. Access to this program will be tightly controlled.
2) The user must have a database logon that allows access to the DIDADMIN schema.
3) All user names and digital ID’s are permanent: they can not be deleted or changed, you can only add new users and digital ID’s.
4) Passwords are stored securely, encrypted, and can only be replaced, not reviewed.
Note: The non-repudiation strength of the eSig feature relies on the security of the database server where CISPRO security information is stored. The tightest possible control should be maintained on authorized access to the DIDADMIN schema.
1 Logging into the DIDMGR
1) Start the DIDMGR program and enter the correct BDE alias information for the database server
2) Enter a valid DIDADMIN schema login
3) Click OK
2 Creating New Accounts
In order to use the eSig version of CISPRO, each user name security account in CISPRO must be exactly matched to a user name account in DIDMGR.
1) In DIDMGR, select Edit | New User
2) enter a unique user name and the password (twice).
Note: passwords must be mixed letters and numbers without repeating character sequences.
3) Click OK
4) modify the password expiration, and account enable as needed.
5) click the Digital ID button
6) Click Create New
7) Click Generate Random button
8) Click OK, then OK again to Close.
9) 10) Repeat from step 1 for each user.
Note, accounts can not be deleted. To reassign a lost password, select Edit | Change Password
3 Changing Digital ID
New Digital ID’s can be assigned periodically as needed. Old Digital ID’s must be obsoleted with an explanation as to why this was done. They are never deleted from the user account.
1) Select user account
2) Click Digital ID button
3) Click Obsolete
4) enter an explanation and click OK
5) click Create New
6) Click Generate Random
7) Click OK
8) Click Close
4 Security Traps
ESig is designed to prevent unauthorized access to CISPRO. This is done in several ways:
1) All login/log out events are logged. Use View | Monitor Login Events to review the log.
2) Incorrect passwords entered for valid user name are captured to the Log.
3) Incorrect passwords entered for valid user names 3 times in a row will disable the account.
4) All accounts have an expiration, after which the account is automatically disabled.
When accounts are disabled, the system administrator must use the DIDMGR program to fix the problem: either changing the expiration date on the account, setting the Failed Attempts back to zero, or simply re-enabling the account.
2 Electronic Records
The eSig feature produces audit trail data for all data tables in the system, which can be modified by a user. There are three methods for reporting on the audit trail:
1) Use an adhoc report design which accesses the AUDIT_tablename in question.
2) Use the Analyze Audit Trail History window to query the Audit tables
3) Use the Audi Trail Wizard
1 Adhoc Audit Trail Reports
DIDMGR ships with a set of example audit trail report designs, which can be used as the basis for new reports. Basically, an audit table is added to the report, fields are selected, filters are specified for the correct data of interest, and if desired, a page layout is created.
One important special feature is the ability to do real-time data verification. Every record in the audit trail is stamped with the database server date/time, user name, digital ID, and all fields values. This data has been cryptographically hashed, such that it would be impossible to alter any field value in the audit trail record and have the hash verify. The DIDMGR program knows how to verify this hash against the current audit trail record field values. In this way it is possible to verify that the record has not been altered after it was inserted into the audit trail.
All that is required to add verification to a report is to add a custom field named "Verify_Data". This report field will display as either "YES" (the record verified OK) or "NO" (the record has been altered). This is demonstrated in the Audit_Main.srw report provided with DIDMGR.
Refer to the section on Report Design for more information on building adhoc reports.
2 Analyze Audit Trail History
Another reporting feature is the ability to view the Audit Trial using the Analyze Audit Trial History window.
Creating a query is as simple as selecting the Audit Table and Key Field from the drop down lists, entering the Match To value and clicking the Search button.
3 Audit Trail Wizard
To provide users with an easier audit trail reporting system, CISPRO also includes an Audit Trail Wizard. The Wizard simplifies the process of generating verification of certain audit trail data. The user is lead through steps for selecting what data, what date period, and how to filter the data. There are three possible views, all are text output.
1 Timestamp listing (compact)
This listing will simply show a list of records in the specified period. Only the audit info (audit record ID, date/time, operation, user name, digital ID, verification result) will be displayed.
2 Full record listing (verbose)
All field values will be listed for each record in the selected data set.
3 Field Changes (analysis)
DIDMGR will compare each audit trail record with a matching key value (defined internally by CISPRO) for changes between records. This allows the user to review the sequence of changes that occurred throughout the lifetime of the dataset.
4 Perform Data Verification
As with the Adhoc Reporting feature for audit trail review, checking this option will cause DIDMGR to verify the cryptographic hash of each record, verifying that the record has not been altered since it was inserted.
4 General Information On the eSig Feature: Changes to Database
The following additions are made to the CISPRO database to provide infrastructure for the eSig feature:
1) triggers on various tables on user schema
2) DIDMGR schema for audit trail storage and user security info
3) AUDEXT table added
4) Additional stored procedures in user schema
5 Changes to the CISPRO 2000 Application for eSig
1) Network polling is always OFF
2) Security is always ON
3) Auto-logout on Idle is always ON with minimum of 2 minutes
4) All batch processing operations (RIBM actions and Tools menu) require revalidation of user name and password prior to performing actions.
5) All data operations are captured to the audit trail along with the server datetime stamp, user name, digital ID, operation type, and encrypted record/audit stamp hash data.
Subsystems Design
1 Inputs and Outputs
1 User Input Information
The NASU Chemical Inventory System (CISPRO) is an off-the-shelf system. Inputs, processes and output definition is a tool for development of custom programmed software and in not necessary for the integration of off-the-shelf software. For clarification, Inputs and outputs follows:
Inputs:
Location Information
Vendor Information
Material Characteristics
Material Hazard Data
Barcode Container Information
Inventory information
Outputs:
Location Information
Vendor Information
Material Characteristics
Material Hazard Data
Container Labels
2 Reports
In particular CISPRO screens or functions available to the user there are a variety of reports available. The style and context of these reports can be customized, else they default to the current standard configuration stored by the CISPRO system. Users can print reports for individual records, or expand and limit the size of reports based on user-defined criteria.
The following is an abbreviated list of standard reports included in the CISPRO system:
Standard reports include the following data, which are all searchable regardless of formatting or font:
1 ChemicalAmounts.srw Report
The ChemicalAmounts.srw report will produce a listing of each chemical and the amount at each location (all containers per location).
2 ChemicalAmountsByLocation.srw Report
The ChemicalAmountsByLocation.srw report will produce a listing of each location, and then each chemical at that location (and the amounts).
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3 Maximum Exceeded and Reorder Needed Reports
These two reports use the Warning Limits settings found on the Physical tab. They both total amounts based on the Reportable Units settings for each chemical. The Above Maximum reports shows items which have a total amount greater than the Maximum Allowable Warning Limit level. The Reorder report shows items below Minimum Allowable level. This data can also be formatted for E-Mail and sent via the Email Notification system.
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4 Expired Containers
This report generates a list of containers whose expiration date is prior to today (the date you run the report). Note that Expiration Dates are specified for each container, and are set when they are Added (from the Qty/Locations tab). This data can also be formatted for Email and sent via the Email Notification system.
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5 Disposal List
This report provides details on each disposed container for a specified date period.
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6 Transaction and Usage Reports
Provide various ways of displaying transaction data (assuming you have been using transaction logging).
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7 Customizing Reports
CISPRO 2000 contains integrated ad-hoc reporting with full user control. Database reporting is a complex subject and even the most intuitive reporting tool can lead the user astray if they are inexperienced. That is why CISPRO 2000 comes with the built-in reports described earlier. You can use them as a basis for creating your own reports.
8 Barcode Labels
CISPRO provides a number of custom barcode label options. For backwards compatibility, SRW custom label files are still supported, but they are no longer the recommended method. (SRW custom label files are labels that are created in the report engine of CISPRO 2000 which is optimized for 8.5x11 reports).
CISPRO Custom Label Design Files (LBL) can be used with any printer that has a valid Windows Printer Driver which supports graphics. For example, the Eltron TLP printers which can be purchased from ChemSW. These printers have a Windows Graphical Printer Driver and are compatible with LBL files.
CISPRO contains a Label Designer with WYSIWYG display of the label design. To access this designer:
1) Start CISPRO
2) Select File | Configure
3) Go to the Labels tab
4) type a filename that ends in .LBL such as label1.LBL into the Custom Default Label box
5) Right-click the box and select Design
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If your printer does not have a graphics capable printer driver, but it does support EPL or ZPL (the Eltron or Zebra macro language for printing labels) you may want to refer to the Using ZPL and/or EPL for label printing topic.
In addition to the default, it is possible to define other custom label formats, and switch between them during the CISPRO session. To add additional label files, the system administrator would edit the \cispro\data\cis3.ini file (global system settings for all workstations) as follows:
[Label Files]
lines=2
label_1=Big_Label.lbl
label_2=Small_Label.lbl
1 Barcode Symbologies
CISPRO uses Code 3 of 9 (Code39) barcode symbology as the default. This symbology supports letters, numbers, and some punctuation (hyphens, dots). The barcode width is directly proportional to the amount of text encoded. For this reason, an 8 character barcode will require almost 2 inches of width.
There are other Symbologies which CISPRO supports (EPL and ZPL support even more), but only one other is worth mentioning here. In cases where a very small label is required, it is possible to use Code 128 C symbology to produce an 8 digit barcode that is only 0.8 inches wide. However, this symbology only supports numbers. If you wish to use Code 128 C with CISPRO, you will need to configure CISPRO to generate numeric-only Unique Container ID’s (see the section on Unique Container ID Generation).
Also note that thermal label printers should always print their barcodes in the same direction as the print head - that is to say, perpendicular to the direction of travel out of the printer. The printer has much greater resolution across the thermal print head when printing in this direction, and this allows the barcode to print with sharper lines even at smaller sizes. It is possible to rotate barcodes in the designer, and you should also consider whether to use label stock that is rotated correctly for your purposes to start with.
2 Using ZPL and/or EPL for label printing
For printers that do not have a Windows Printer Driver, but do support Eltron Printer Language (EPL) or Zebra Printer Language (ZPL), you can use the Windows Generic Text Printer Driver to send these printer macro command files for printing custom label designs.
Designing these types of labels requires a knowledge of EPL or ZPL, or alternatively, you can use a label design program like BarTender from Seagull Scientific Software to print a design to a file.
Once you have the EPL or ZPL file, you can place CISPRO field tags into the file so that when label is printed, the correct container information is placed on the label.
Here is a list of possible fields:
|Field Tag |Description |
|{@caption} |BATCH.UniqueContainerID |
|{@title} |MAIN.NameRaw |
|{@trailer} |SIZETYPE.Size_Description |
|{@NameRaw} |MAIN.NameRaw |
|{@Comments} |MAIN.Cmments |
|{@ID2} |MAIN.ID2 |
|{@ID3} |MAIN.ID3 |
|{@Description} |MAIN.Description |
|{@HazardDescription} |MAIN.HazardDescription |
|{@Lot_Number} |BATCH.Lot_Number |
|{@Expiration} |BATCH.Expiration (mm/dd/yyy format) |
|{@Responsible} |BATCH.Responsible |
|{@Exp2} |BATCH.Expiration (mon-yyyy format) |
|{@Size_Description} |SIZETYPE.Size_Description |
|{@Catalog_Number} |SIZETYPE.Catalog_Number |
|{@ExtraText} |SIZETYPE.ExtratNumber (product id code) |
|{@Location} |LOCATES.Location |
|{@username} |Current login name |
Data
1 Data Dictionary
The scripts used to create the oracle database define the database. They consist of three scripts as follows:
• 1_cisuser.sql
• 2_cisuser_sp.sql
• 3_cisadmin.sql
They are included in Appendix 1 – Data Definitions.
2 Data Archiving
Necessities for data archiving were not included in the functional requirements specification for the system. The NASU Chemical Inventory System (CISPRO) Oracle database server as implemented at Merck is capable of storing over two million records. At a maximum rate of 500 records per day, it will take 16.7 years before data archival is needed. The actual anticipated data input rate will be much less that the maximum rate. Considering these figures, data archival is not a critical function of the system.
If data archival is necessary, the internal tape backup system installed on the server and backup utilities will be used. See 1.7 for details of the backup system.
Limitations and Expandability
1 System Limitations
There are no limitations on the number of maximum users for the CISPRO system as a whole. However, concurrent usage allowed on the CISPRO system is currently set at 5, which is dependent upon the number of users allowed by the current license code distributed upon installation of the CISPRO system. Changes to the installed licensing information must be cleared with the software vendor.
2 Mass Memory Space
A new CISPRO database is not limited in terms of size. However, a database of 1000 records will require approximately 3.5 MB of disk space. Additionally, the CISPRO database will grow or shrink in size to accommodate the number of records being actively stored. As currently installed the database consumes 2.6 GB of drive space, with 4.5 GB remaining.
3 System Expandability
New versions of CISPRO software may be made available at a future date. The decision to update to newer versions, or to install upgrades, will be subject to approval at that time. General maintenance of the CISPRO system is conducted by Merck staff and, when necessary, the vendor.
Documentation
1 References and Standards
1 Internal Merck & Co., Inc. SOPs and Guidelines
|Document Number |Title |Source |
|Merck Corporate Policy Number 28 |Computer System Validation |Merck Management Guide |
|POL 3.30 |Automation Validation Policy |MMD Quality Manual Policy |
|VGDL 3.30 |CSV: System Life-Cycle Methodology |MMD RAS-Validation Guideline |
|VGDL 3.33 |CSV: Requirements Specification |MMD RAS-Validation Guideline |
|VGDL 3.32 |CSV: Configuration Management |MMD RAS-Validation Guideline |
|VGDL 3.34 |Computer System Validation: Design |MMD RAS-Validation Guideline |
| |Specification | |
|SOP 451-104 |MIS Computer Backup Storage Control |MMD - Wilson Standard Operating Procedure|
|Stability Lab-078-QAP.doc |CISPRO System Quality Assurance Plan |Merck Management |
3 External / Vendor Supplied Documentation
|Title |Source |Location |
|NASU Chemical Inventory System |ChemSW |MMD – Wilson NASU Retention Room A |
|(CISPRO) Installation CD w/users | | |
|manual | | |
|Videx Laserlite Pro Operators Manual |Videx |MMD – Wilson NASU Retention Room A |
|2722, 2742, 3742 Thermal Printer User |Eltron |MMD – Wilson NASU Retention Room A |
|Documentation & Software CDROM | | |
2 Modifications to the Detail design Specification
The Detail Design Specification is the basis for qualification, validation and acceptance of the developed system. The developer is responsible for identification of any exceptions to the Detail Design Specification and initiation of a revision. During the course of a project, additional revisions to the Detail Design Specification are to be expected. Any member of the project team or the developer may initiate these revisions. In all cases, a formal procedure should be identified that provides for incorporation of the proposed revision including an appraisal of the impact of the proposed change on the project. The revised document should then be reviewed and approved prior to the initiation of further development.
Appendix 1 – Data Definitions
Appendix 2 – Deployment Protocol
Title: Deployment Protocol
Purpose: Describe requirements and procedure for deployment.
Contents
1. Requirements 11
1.1 Installation Tools 11
1.1.1 Software 11
1.1.2 System Hardware and Software 11
1.1.3 Hardware (optional) 11
1.1.4 Configuration Data 11
1.2 Server 11
1.2.1 Oracle Server 11
1.2.2 File/Application Server 11
1.3 Clients 11
1.4 Site Specific Issues 11
2. Oracle Server Setup 11
2.1 Logins 11
2.2 Scripts 11
3. File Server Setup 11
3.1 BDE Installation 11
3.2 CISPRO Installation 11
4. General Client Setup 11
4.1 Oracle (OCI) Installation 11
4.2 CISPRO Installation 11
4.2.1 BDE 11
4.2.2 CISPRO 11
4.2.3 ChemACX 11
4.2.4 eSig DIDMGR 11
5. CISPRO Application Setup 11
5.1 Server Connection Setup 11
5.2 Security Setup 11
eSig Security Setup 11
5.2.2 Admin Account 11
5.2.3 User Accounts 11
6. Printing Setup 11
6.1 Report Printer Setup 11
6.2 Label Printer Setup 11
6.2.1.1 Shared Printer – Network Driver Installation 11
6.2.1.2 Local Printer – Local Driver installation 11
6.2.2 Configuring the installed printer drivers 11
6.2.3 Custom Label Layouts 11
6.2.4 Label Form Factor 11
7. RIBM Setup 11
7.1 Hardware Installation 11
7.1.1 Videx LaserLite Pro 11
7.1.2 Symbol PDT6800 11
7.2 RIBM Software Configuration 11
7.2.1 Generic Functions 11
7.2.2 Custom Functions 11
8. Mettler Electronic Balance Configuration 11
9. CISPRO Configuration 11
Addendum A. ChemACX Configuration 11
Addendum B. Site Label Layout 11
Defaults 11
Label Files 11
Label Printer Info 11
Local ini settings 11
Addendum C. Site RIBM Configuration 11
Program Filename 11
Program Filename 11
Program Filename 11
Program Filename 11
Program Filename 11
Program Filename 11
Addendum D. Site CISPRO Customization 11
Addendum E. Distribution CD Content List 11
1. Requirements
GENERAL REQUIREMENTS FOR PERFORMING ALL PHASES OF CISPRO SOFTWARE INSTALLATION.
1.1 Installation Tools
1.1.1 SOFTWARE
▪ CISPRO CDROM
▪ Optional Catalog Database CDROMS (ChemACX, ECID, TSCA)
▪ SQL*Plus with OCI installed
▪ Net Service Name / alias defined for Oracle server
▪ Hyperterminal (for RIBM and balance testing)
▪ Seagull Printer Driver (for Eltron Printer)
▪ Windows OS CDROM (for generic text driver)
▪ Other Label Printer Driver disks
1.1.2 System Hardware and Software
▪ Windows 9x,Me,NT4, 2000 workstations
▪ Oracle 7.3 or better
Note: if using Oracle 8i or higher, OCI client tools must match version. CISPRO will not work properly if the client is running v7.x tools and the server is Oracle 8i. This is a known bug in Oracle.
1.1.3 Hardware (optional)
▪ Eltron Printers with printer cables
▪ Videx LaserLite Pro with cradle and cable
▪ Symbol PDT6800 with cradle and cable
▪ Mettler Electronic Balances with proper serial cable
1.1.4 Configuration Data
Addendum’s B through C of this protocol provide worksheets for both system global configuration (all stations), and local station configuration (one sheet per station affected). They should be completed with input from the customer and used to configure the software on-site.
1.2 Server
1.2.1 ORACLE SERVER
▪ Net Service Name / TNS alias server alias must be identified and accessible from installation machine
▪ SPL*Plus access or equivalent script capability must be available
▪ DBA must create logins with known user names and passwords, which have RESOURCE and CONNECT roles assigned.
▪ 10MB of table space is normally adequate for most CISPRO initial deployments, using auto-increment of space in 10% blocks. More space may be needed if the number of chemicals times the number of containers exceeds 25,000.
1.2.2 File/Application Server
CISPRO requires approximately 15MB for the BDE shared DLL’s installation, and 10MB for the CISPRO installation. The application supports UNC pathing.
1.3 Clients
CISPRO REQUIRES NO CLIENT STORAGE. IT CREATES TWO LOCAL INI FILES NAMED CIS3.INI AND GRIDS.INI IN THE \WINDOWS OR \WINNT DIRECTORY.
If installing the ECID, TSCA, or ChemACX catalog options, additional hard disk space is required on the workstation. The space required varies: approx. 50MB TSCA, approx. 250MB ECID, approx. 800MB ChemACX.
If installing ChemACX, the workstation must have a current ODBC driver for Microsoft Access 97 or better.
1.4 Site Specific Issues
1.4.1 TWO DIFFERENT DEPLOYMENTS.
The Merck NASU facility will use two different versions of CISPRO. One is eSig enabled (21 CFR Part 11 compliant audit trail features), the other is a standard CISPRO installation. Both versions will be hosted on Oracle. Each version will be connected to a different logical database. This means that 2 schemas will be needed for the regular CISPRO version, and 3 schemas will be needed for the eSig CISPRO version.
Additionally, for the regular CISPRO version, there will be two different types of handheld hardware configurations: Videx LLP, and Symbol PDT6800 (intrinsically safe areas only). This means there are effectively 3 different workstation configurations for handheld hardware (see RIBM Configuration Addendum).
Finally, this site uses a custom label design (merck.lbl, see Label Addendum). This label is system global across both version. It requires numeric only, 6 digit padded serial container ID numbers.
This site does not use special features of CISPRO such as Add On List catalogs, or electronic scale interfacing. No data importing will be done during deployment.
2. Oracle Server Setup
2.1 LOGINS
DEFAULT LOGINS/PASSWORDS FROM CISPRO SCRIPTS ARE:
cisuser/userpwd
cisadmin/masterkey.
Logins and passwords can be changed as needed, but the scripts will need to be “search & replaced” to accommodate the changes to schema names.
Steps:
1) create login cisuser with RESOURCE and CONNECT roles.
2) create login cisadmin with RESOURCE and CONNECT roles.
3) for eSig deployment, create an additional login didadmin with RESOURCE and CONNECT roles.
4) if the logins are changed, search and replace the CISUSER, CISADMIN and DIDADMIN (eSig only) schema names in all scripts.
2.2 Scripts
STEPS:
1) start SQL*Plus login as CISUSER and run the following scripts in order:
1_cisuser.sql
2_cisuser_sp.sql
2) start SQL*Plus login as CISADMIN and run the following scripts in order:
3_cisadmin.sql
3) for eSig deplyment, start SQL*Plus and login as didadmin, then run script:
didmgr.sql
4) for eSig deployment, start SQL*Plus and login as cisuser, then run script:
diduser.sql
Note: The eSig security model will prevent logging into CISPRO to create an admin account. This is most easily corrected by modifying the existing default admin account in the CISADMIN schema with the following SQL command:
Update CISADMIN.PWD2 set username=’some_expected_didmgr_acctname’ where username=’admin’;
3. File Server Setup
3.1 BDE INSTALLATION
NOTE: S:\APPS\CHEMSW\BDE\ IS THE EXAMPLE FILE SERVER INSTALLATION PATH USED IN THIS DOCUMENT FOR THE BDE. PLEASE REPLACE THIS PATH WITH THE PROPER BDE PATH TO YOUR NETWORK FILE SERVER.
Steps:
1) On the supplied CD, navigate to the BDE folder. Copy all of the files within the BDE folder to S:\apps\chemsw\bde (replace with the correct path to your file server) Be sure to remove the read-only attribute from these files and folders after copying them from the CD.
2) Navigate to the new BDE folder on your file server and open the file default.ini in notepad. Verify the following values:
3) Search for this line: [Database Engine\Settings\DRIVERS\ORACLE\DB OPEN]
4) Then verify that the lines within that section are as follows:
SERVER NAME={Oracle TNS alias here}
NET PROTOCOL=TCP/IP
5) Save and exit the file.
Note: The TNS alias listed in step #4 above is the same alias used in section 4.1 (client OCI setup). This alias is defined by the Oracle DBA.
3.2 CISPRO Installation
NON-ESIG STEPS:
1) Navigate to the 12411 folder on the CD. Copy all contents into the S:\apps\chemsw\cis installation folder.
ESIG Steps:
1) Make a copy of the S:\apps\chemsw\cis folder for ESIG use, for example S:\apps\chemsw\cisESIG. Be sure to also copy the entire contents.
2) Navigate to the 12422 folder on the CD. Copy all contents into the new folder created in step 1 (S:\apps\chemsw\cisESIG)
3) From this folder new folder, remove the following file types:
ADV*.S
BASIC*.S
4. General Client Setup
4.1 ORACLE (OCI) INSTALLATION
STEPS:
1) install Oracle client utilities (OCI) to the workstation
2) Use Net8 Easy Config to create a Net Service / TNS alias to the Oracle server
3) verify the connection is valid using SQL*Plus and the cisuser login as necessary.
4.2 CISPRO Installation
4.2.1 BDE
Steps:
1) Run BDEINST.EXE in the BDE folder on the fileserver. Choose the third option, “Install BDE32 using Specified Source Directory”, then click Browse, and navigate to the S:\apps\chemsw\bde. Click open, and then finish.
Note: The following steps only need to be performed on the FIRST workstation. If you have already performed these steps once, you do not need to do them again: move on to section 4.2.2.
2) Launch the BDEADMIN.EXE utility located in the S:\apps\chemsw\BDE folder. Go to the configuration tab, and drill down to Configuration | Drivers | Native | Oracle. For Oracle 8i, verify (and change if necessary) the following settings as follows:
DLL32: SQLORA8.DLL
VENDOR INIT: OCI.DLL
NET PROTOCOL: TCP/IP
SERVER NAME: {Oracle TNS Alias here}
3) Press CTRL-A, respond OK to the prompt to save all edits, and then exit and re-start the BDEADMIN.EXE
4) On the databases tab, right-click and select “New” to create a new database alias. Choose “Oracle” from the drop down list. The alias name is now selected – change it to something meaningful, for example ChemSW_Oracle. Right-click, choose Apply. Verify that the settings for this new alias (especially the server name) are correct. If you must make any changes, do not forget to right-click again and choose Apply. During installation of other ChemSW Products, this alias name will be used, so please note it.
5) To test the new alias, you can either use the accounts created by the DBA for this software (reference the DBA installation sheet), or you can use a default Oracle logins, such as scott/tiger. You can also choose not to test the alias at this point. To test the new alias, right-click the alias and select Open. Enter the login/password you wish to test (either those assigned by the DBA or the scott/tiger login) and then click OK. A green box around the alias icon (after a short delay) indicates that the alias is functional.
Exit the BDEADMIN program. BDE configuration is complete.
4.2.2 CISPRO
Note: CISPRO supports both UNC and logical drive mapping. The preferred method is logical drive mapping. Given that certain features of CISPRO use full pathing to external files (email notification reporting for example) it is a good idea to use common shared drive mappings across all workstations that will be using CISPRO.
Steps:
1) create a desktop shortcut to CIS32ORA.EXE located in the \CISPRO folder on the fileserver.
2) make sure that the shortcut has the working directory (also known as the “Start In” directory) set to the same folder where cis32ora.exe is running from.
4.2.3 ChemACX
ChemACX is an optional add-on catalog database available for CISPRO. The Catalog is provided as a structure database and an MDB file. For this reason, the workstation must have an ODBC driver for Microsoft Access (97 or better).
See ChemACX Configuration Addendum.
4.2.4 eSig DIDMGR
For eSig deployments, copy the DIDMGR.EXE & CRYPT01.DLL files to the fileserver. While this program may be copied to the same directory where cis32ora.exe (CISPRO main executable) is installed, it is important to maintain tight security on DIDMGR.EXE. For this reason, it is recommended that the program be placed in a separate directory from the rest of CISPRO, and directory permissions be configured so that only the System Administrator can run files in that directory.
Note the DIDMGR requires a valid BDE installation on the workstation from which it will be run, just like CISPRO.
Make sure you create a \data folder under the folder where DIDMGR is installed.
Make sure you create a \reports folder under the folder where DIDMGR is installed and place the Audit_?*.srw sample reports there.
5. CISPRO Application Setup
NOTE: AT THIS POINT, THE PROTOCOL ASSUMES THAT ALL PREVIOUS STEPS HAVE BEEN COMPLETED. THIS MEANS THE ORACLE SCHEMAS HAVE BEEN CREATED, THE OCI HAS BEEN INSTALLED AND CONFIGURED FOR THE CORRECT TNS ON THE WORKSTATION, THE BDE AND CISPRO APPLICATION HAVE BEEN DELIVERED TO THE FILESERVER, THE WORKSTATION HAS BEEN CONFIGURED FOR BDE USE, AND THE WORKSTATION HAS A CISPRO SHORTCUT.
5.1 Server Connection Setup
STEPS:
1) Start CISPRO
2) If the Server Access dialog does not display, select File | Configure… (if the Server Access Setup dialog does not appear, click the Server Setup… button).
3) Fill in the User tab as follows:
alias: ChemSW_Oracle (see section 4.2.1 Step #3)
login: cisuser (see section 2.1 Step #1)
password: userpwd (see section 2.1 Step #1)
4) Fill in the Admin tab as follows:
alias: ChemSW_Oracle (see section 4.2.1 Step #3)
login: cisadmin (see section 2.1 Step #2)
password: masterkey (see section 2.1 Step #2)
5) Fill in the Concurrency tab as follows:
alias: ChemSW_Oracle (see section 4.2.1 Step #3)
login: cisuser (see section 2.1 Step #1)
password: userpwd (see section 2.1 Step #1)
6) Click OK
7) Exit CISPRO. The changes will take effect at the next startup of CISPRO.
5.2 Security Setup
MOST CISPRO INSTALLATIONS HAVE SECURITY ENABLED. THIS PROVIDES ACCESS LEVEL ROLES FOR EACH USER, LIMITING WHAT THEY CAN DO IN THE APPLICATION. IT IS CRITICAL THAT AN ADMIN ACCOUNT BE CREATED PRIOR TO ENABLING SECURITY SO THAT THE SYSTEM ADMINISTRATOR DOES NOT BECOME “LOCKED OUT” OF THE APPLICATION.
Note: For eSig deployments only, the DIDMGR.EXE program must be installed and security accounts configured prior to creating security accounts in CISPRO.
eSig Security Setup
For eSig deployments, every user must have a security account defined in the DIDMGR program. This account will have full user identity information, including identity verification data (e.g. Driver’s License number), and a unique Digital ID. Note that both User Names and Digital ID’s are UNIQUE, and can not be deleted. For this reason some pre-planning is needed to make sure that user names are sufficiently unique for all users. Passwords are encrypted in the database and can not be retrieved. Therefore, if a password is lost, the system administrator will need to assign a new password to the user.
Steps:
1) Start DIDMGR.EXE
2) Enter BDE alias (section 4.2.1 step #3) and didadmin login and password (section 2.1 step #3)
3) Click OK to login
For each user:
4) Select Edit | New…
5) Enter username and password (twice), then click OK
6) Modify the account expiration as needed
7) Check Account Enabled if this account should be active
8) Fill in identity info with full user name and indentity document info
9) Select Edit | Save Changes
10) Click Digital ID button.
11) Click Assign New… button
12) Click Generate Random button
13) Click OK and then Close
14) Repeat from step #4 for each new user
15) After exiting DIDMGR, copy [didmgr]\data\logon.ini to [cispro]\data folder.
5.2.2 Admin Account
Note: The eSig security model will prevent logging into CISPRO to create an admin account. This is most easily corrected by modifying the existing default admin account in the CISADMIN schema with the following SQL command:
Update CISADMIN.PWD2 set username=’some_didmgr_name’ where username=’admin’;
Since the admin account is defined by default with Configuration access (System Modify privilege) when the database is created, this will allow you to enter CISPRO and begin configuring other accounts.
Steps:
1) Start CISPRO
2) Select File | Configure
3) On the Defaults tab, click Security…
4) Click the Levels… button.
5) Click Add, enter “admin” into the Level Name box and then click Save
6) Check the Modify Configuration (ADMIN) permission, then click Save again
7) Click Close
8) Click New
9) Type in an admin account name, password, and set the Access Level to the admin level that was just created.
10) Click Save, then Close
11) Click OK to close the Configuration dialog.
12) Select File | Login and then use the new account to re-enter the system.
5.2.3 User Accounts
Now that an admin account has been created, it is necessary to create other access level roles for users. Typically, the admin account (with Modify Configuration privilege) is reserved for only one system administrator. All other users have different access levels that does not have this privilege.
Note that without the Modify Configuration privilege, the Configuration dialog will look dramatically different to the application user. All features which are global configuration for CISPRO will be inaccessible. Only local hardware configuration (printer selection, electronic balance interface, and RIBM hardware configuration) will be available.
For eSig versions, these usernames must exactly match usernames created in DIDMGR (section 5.2.1). Password assigned here are not used but must not be blank. Suggested dummy value is ”1”.
Steps: (to create a user account)
1) Login as the admin
2) Select File | Configure
3) Click the Security… button
4) Click Levels… button
5) define a new level with appropriate permissions as necessary
6) Close the Access Levels form
7) Click New to create a new user, enter username and password (twice)
8) assign the correct Access level from the list
9) Click Save
10) Repeat for each user. Multiple users can share the same Access Level (role).
6. Printing Setup
6.1 REPORT PRINTER SETUP
CISPRO REPORT PRINTERS MUST BE STANDARD WINDOWS PRINTERS DEFINED ON THE WORKSTATION WHERE CISPRO WILL BE RUNNING. NETWORK AND/OR LOCAL PRINTERS MAY BE USED. ANY PRINTER WITH A VALID GRAPHICAL WINDOWS PRINTER DRIVER MAY BE USED, BUT PAGE SIZE PRINTERS ARE BEST SUITED TO REPORTS.
Note that printer selection is a local workstation configuration parameter, which is stored in the [windows]\cis3.ini file. The printer name is persisted between CISPRO session, and will produce an error if CISPRO is started when the printer has been removed from the workstation’s printers folder.
Steps:
1) Start CISPRO
2) Select File | Configure
3) Select the Labels tab
4) Click Browse… next to the Report Printer section
5) Select the printer for reports from the list, and set the orientation if necessary.
6) Click OK
7) Click OK to save the Configuration dialog info.
6.2 Label Printer Setup
CISPRO ALLOWS AN ALTERNATE PRINTER TO BE SELECTED FOR LABEL PRINTING. THIS IS NORMALLY DONE WHEN A DEDICATED LABEL PRINTER IS AVAILABLE (FOR EXAMPLE THE ELTRON THERMAL TRANSFER PRINTERS SOLD BY CHEMSW, INC.). LABEL FORM FACTORS MUST BE CORRECTLY CONFIGURED FOR THE PRINTER DRIVER BEFORE TRYING TO PRINT FROM CISPRO.
Note: Windows printer drivers vary substantially in how they are configured. This section applies specifically to the Seagull Eltron TLPxx42 driver series. Other drivers and other printers will require different configuration steps.
6.2.1.1 Shared Printer – Network Driver Installation
You need to know the network address of the printer. This is either a IP address such as 127.0.0.1 or a server path such as \\server4\eltron2742.
Steps:
1) Logon to the server the printer will be shared from.
2) Select Start | settings | Printers and then double-click Add Printer
3) Select local printer, configure the port as necessary
4) When prompted for driver selection, click “have disk” and select the Seagull driver folder
5) Complete the printer installation, configure the security and share the printer.
6) Logon to the workstation with Administrator privileges
7) Select Start | Settings | Printers and then double-click Add Printer
8) Select Local Printer (even though it is a network printer), and connect to a parallel port (use LPT2).
9) Click Have Disk… and select the seagull driver folder.
10) Select your model of printer and then click Finish to install the printer, do NOT print a test page.
11) select the printer, right click and select Properties
12) Go to the Ports tab. If the port you need is not listed, click Add Port
13) Select Digital network Port or TCP port and then enter the printer path or IP.
14) Click OK then check the correct port and click OK
6.2.1.2 Local Printer – Local Driver installation
Steps:
1) Logon to the workstation with Administrator privileges
2) Select Start | Settings | Printers and then double-click Add Printer
3) Select Local Printer and select the appropriate port.
4) Click Have Disk… and select the seagull driver folder.
5) Select your model of printer and then click Finish to install the printer, do NOT print a test page.
6.2.2 Configuring the installed printer drivers
Steps:
1) Highlight the printer and then select Document Defaults from the Printer folder’s File menu.
2) Click Page Setup tab, then Edit…
3) Adjust the form factor for the page size to match your label
4) Click OK, then OK again.
5) The printer is now configured for use.
Note: If using ZPL or EPL label designs, the label printer will be connected through the Windows Generic Text Driver. This should be connected to the printer (local or network port) in the same manner as a normal graphical windows printer. Text printers do not need the Document Defaults setup.
6.2.3 Custom Label Layouts
CISPRO has a built-in label format which may not suit the deployment environment. It is possible to define custom label layouts and use them instead. Custom label designs are normally created by ChemSW and delivered to the customer as .LBL files. IN cases where a printer does not have a valid Windows Printer Driver, it is also possible to create printer “macro” labels for Zebra (ZPL) and Eltron (EPL) printers.
Steps:
1) Obtain the custom label files from ChemSW, place them in the same directory on the fileserver where the cis32ora.exe file is located.
2) Start CISPRO
3) Select File | Configure
4) Go to the Labels tab
5) Check Use Custom Default Label File
6) enter the path to the DEFAULT LBL, ZPL, or EPL file.
7) Click OK
8) For additional custom formats, add the following to the [fileserver]\cispro\data\cis3.ini. To add new labels to the toolbar drop down menu for barcode printing:
[Label Files]
lines=2
label_1=2nd_label_filename
label_2=3rd_label_filename
See Site Label Layout Addendum for further instruction.
6.2.4 Label Form Factor
If using .LBL labels, or the standard built-in format, (not required for SRW, EPL, or ZPL labels) the Label Form Factor must be specified:
Steps:
1) Start CISPRO
2) Select File | Configure
3) Select the Labels tab
4) Click the Barcode ID Label Setup… button
5) Adjust the settings as needed. For a label printer using 2 inch wide by 1 inch high labels on a roll:
Printer Type: Continuous Roll
Labels Per Page: 1
Label Height: 2
Label Width: 1
Copies: 1
Labels Across: 1
Labels Down: 1
X Origin: 0
Y Origin: 0
Horizontal Gap: 0
Vertical Gap: 0
6) Click OK and then OK again.
7. RIBM Setup
7.1 HARDWARE INSTALLATION
CABLE NOTE 1: THE VIDEX LLP CRADLE COMES WITH A PROPRIETARY RJ11-DB9F CABLE. THIS WILL CONNECT TO THE TYPICAL WINDOWS PC SERIAL PORT CONNECTOR WHICH IS A DB9M. IF THE WORKSTATION USES A DB25, AN ADAPTER MAY BE NEEDED. THIS SHOULD BE OBTAINED BY THE CUSTOMER PRIOR TO CHEMSW’S ARRIVAL.
Cable Note 2: The Symbol PDT6800 cradle uses a “null modem” DB25M-DB9F cable. This will connect to the typical Windows PC serial port connector which is a DB9M. If the workstation uses a DB25, an adapter may be needed. This should be obtained by the customer prior to ChemSW’s arrival. This cable can be ordered from Symbol or obtained from a computer supply store.
Both the Videx and Symbol handhelds use a serial port for communication with the host PC. It is critical that a computer technician verify the host PC for an available working COM port, prior to ChemSW’s arrival. ChemSW can not control hardware incompatibilities in a customer’s environment.
The recommended method for testing the hardware is to use Windows Hyperterminal to direct connect to the selected COM port at 9600 baud, 8 data bits, 1 stop bit, and No parity. A device such as a modem or other serial device can then be connected to the port and checked for comand echo to verify the port is available.
7.1.1 Videx LaserLite Pro
Steps:
1) Insert good batteries into the Videx. Move the lock switch away from the locked position and press then scan key. The display will come on if the device is powered properly.
2) Connect the cradle to the PC COM port using the attached cable.
3) Start CISPRO
4) Select File|Configure, then the Advanced tab
5) Click RIBM Setup…
6) Select Videx Laserlite Pro and set the correct COM Port.
7) Click OK and then OK again.
Testing:
1) Wake up the Videx by pressing the scan button, then set it back in the cradle
2) immediately click the drop down button next to the RIBM button on the toolbar and select Program Collector.
1) If the communications is successful, a message box will be displayed that the Videx is ready to go.
2) Trouble: The most common problems are:
1) Videx is not awake
2) *.s program files are set read-only (must be read/write)
3) COM Port is not available
4) Cable is bad
5) Cradle is bad
7.1.2 Symbol PDT6800
Steps:
1) Charge the PDT prior to use by setting it in the cradle and plugging the cradle into an A/C outlet. Press the red PWR button to turn the unit on. The display will come on if the device is powered properly.
2) Connect the cradle to the PC COM port using the attached cable.
3) Start CISPRO
4) Select File|Configure, then the Advanced tab
5) Click RIBM Setup…
6) Select Symbol PDT6800 and set the correct COM Port.
7) Check the “Device sets mode” box and type MAINPROG.HEX into the box to the right.
8) Click OK and then OK again.
Testing:
1) click the drop down button next to the RIBM button on the toolbar and select Program Collector.
2) Follow the on-screen instructions for programming the PDT.
1) Trouble: The most common problems are:
1) COM Port is not available
2) Cable is bad
7.2 RIBM Software Configuration
7.2.1 GENERIC FUNCTIONS
Steps:
1) Select File|Configure
2) Select the Advanced Tab
3) Click RIBM Setup… button
4) Select the correct Operation mode, and other options
5) Click OK, and then OK again.
7.2.2 Custom Functions
See Site RIBM Configuration Addendum for specifics.
8. Mettler Electronic Balance Configuration
CISPRO PROVIDES INTEGRATED ELECTRONIC BALANCE SUPPORT FOR METTLER BALANCES EQUIPPED WITH RS232 COMMUNICATIONS (SUCH AS MODELS AB,PB,SB,B,PG-S). ALL BALANCES REQUIRE THE CORRECT INTERFACE CABLE. AS WITH RIBM CONFIGURATION, THE SYSTEM ADMINISTRATOR MUST VERIFY THAT THE WORKSTATION WHERE THE BALANCE WILL BE INSTALLED HAS AN AVAILABLE COM PORT.
Steps:
1) Connect the balance to the COM port using the correct cable, and power up the balance.
2) Start CISPRO
3) Select File | Configure
4) Go to the Balance tab
5) Check Enable RS-232 Balance Interface
6) Select Mettler
7) Set communications parameters as needed for the balance.
8) Click OK,
9) Exit and restart CISPRO
Testing:
1) Start CISPRO
2) Navigate to a chemical with a container (or create one)
3) Click Change Qty button
4) place some weight on the balance
5) Click the left balance button in the Change Quantity dialog. If the communication is successful, the weight on the scale will appear in the Amount box.
See Site CISPRO Customization Addendum for specifics
9. CISPRO Configuration
SEE SITE CISPRO CUSTOMIZATION ADDENDUM FOR SPECIFICS
Addendum A. ChemACX Configuration
CHEMACX IS NOT BEING INSTALLED FOR MERCK NASU.
Addendum B. Site Label Layout
MERCK DEPLOYMENT HAS ONLY ONE LABEL DEFINITION.
|Label Description |Filename |Format (LBL,EPL,ZPL,SRW) |
|Merck 0.75” x 2” label |MERCK.LBL |LBL |
| | |Note: |
|[pic] |See label layout reference below. |1) code 128 c format requires numeric only |
| | |barcode format |
| | |2) 0.75” high requires 6 digit container ID|
| | |padding. |
Global INI Settings:
Defaults
[Defaults]
UseCustomLabel=1
CustomLabelFile=[path]\merck.lbl
Label Files
[Label Files]
lines=0
label_1=merck.lbl
Label Form Factor Info
[Bar Code Setup]
Rolls=1
Sheets=0
PerPage=1
Height=0.75
Width=2.0
Copies=1
Across=1
Down=1
X_Origin=0
Y_Origin=0
H_Gap=0.0625
V_Gap=0
UseLowDensity=0
Label Printer Info
Eltron TLP-2642,TLP-2742,TLP-3742
Thermal Transfer on Polyester 0.75” wide, 2.0 inches long, rolled landscape (roll is 0.75” wide)
Seagull Eltron Driver is set for Doc Defaults of: 0.75” wide x 2” high, landscape.
Local ini settings
[Label Printer]
PrnDevice=Eltron TLP3742 (EPL2)
PrnDriver=winspool
PrnPort=\\win2k600\ELTRON
Landscape=0
Orient=0
Height=508 //label height, in inches, multiplied by 254
Width=191 //label width, in inches, multiplied by 254
[Report Printer]
PrnDevice=
PrnDriver=winspool
PrnPort=
Landscape=0
MERCK.LBL Definition (for reference only)
[barcode]
human_readable=1
symbology=3
orientation=1
x=2
y=0
height=30
enabled=1
[text]
lines=9
line_1=@NameRaw 1 20 7 Arial
line_2=Lot: @Lot_Number 18 20 7 Arial
line_3=Purity: @Description 33 20 7 Arial
line_4=Expires: @Exp2 50 20 7 Arial
line_5=@Comments 81 20 7 Arial
line_6=Qty: @Amount 65 20 7 Arial
line_7=
line_8=
line_9=
[label]
height=1
width=2.0
x=0.00
y=0.00
border=0
Addendum C. Site RIBM Configuration
MERCK HAS 3 POSSIBLE WORKSTATION CONFIGURATIONS, AS LISTED BELOW. NOTE THAT PERMISSION FOR THE PROGRAM SHOULD BE SET IN THE HANDHELD PROGRAM INI FILE.
Workstation Configuration 1 – eSig with Videx (Part 11)
|Program Filename |Einout.s |
|INI Filename |Einout.ini |
|Menu Title |Check In/Out (Part 11) |
|Device (LLP,PDT) |LLP |
|Workstation ID | |
|COM Port | |
|Program Filename |Einvent.s |
|INI Filename |Einvent.ini |
|Menu Title |Inventory (Part 11) |
|Device (LLP,PDT) |LLP |
|Workstation ID | |
|COM Port | |
Local INI Settings:
(Use RIBM Setup Dialog for hardware config)
[RIBM MENU]
dynamic=1
enable_clear=0
enable_file=0
enable_program=1
enable_download=1
[RIBM PROGRAMS]
lines=2
line_1=einout.ini
line_2=einvent.ini
Notes: EINVENT.INI & EINOUT.INI should both be set to require MultiRecOps permissions.
Workstation Configuration 1 – Videx (non Part 11)
|Program Filename |inout.s |
|INI Filename |inout.ini |
|Menu Title |Check In/Out |
|Device (LLP,PDT) |LLP |
|Workstation ID | |
|COM Port | |
|Program Filename |invent.s |
|INI Filename |invent.ini |
|Menu Title |Inventory |
|Device (LLP,PDT) |LLP |
|Workstation ID | |
|COM Port | |
Local INI Settings:
(Use RIBM Setup Dialog for hardware config)
[RIBM MENU]
dynamic=1
enable_clear=0
enable_file=0
enable_program=1
enable_download=1
[RIBM PROGRAMS]
lines=2
line_1=inout.ini
line_2=invent.ini
Notes: INVENT.INI & INOUT.INI should both be set to require MultiRecOps permissions.
Workstation Configuration 3 – PDT6800 (non Part 11)
|Program Filename |Pinout.s |
|INI Filename |Pinout.ini |
|Menu Title |Check In/Out |
|Device (LLP,PDT) |PDT |
|Workstation ID | |
|COM Port | |
|Program Filename |Pinvent.s |
|INI Filename |Pinvent.ini |
|Menu Title |Inventory |
|Device (LLP,PDT) |PDT |
|Workstation ID | |
|COM Port | |
Local INI Settings:
(Use RIBM Setup Dialog for hardware config)
[RIBM MENU]
dynamic=1
enable_clear=0
enable_file=0
enable_program=1
enable_download=1
[RIBM PROGRAMS]
lines=2
line_1=einout.ini
line_2=einvent.ini
Notes: PINVENT.INI & PINOUT.INI should both be set to require MultiRecOps permissions.
Addendum D. Site CISPRO Customization
GLOBAL SETTINGS (FILE | CONFIGURE)
|Tab |Item |Setting |
|Defaults |Use Transaction Logging |Off |
|Defaults |Autologin on startup |On |
|Defaults |Default Database Always |On |
|Defaults |Autologout after idle |On |
|Defaults |Autologout interval (minutes) |5 |
|Labels |Use Default Custom Label |On |
|Labels |Default Label Filename |Merck.LBL |
|Customize |Force Automatic Container ID |On |
|Customize |Require valid Vendor |Off |
|Customize |Require valid Catalog# |Off |
|Customize |Require valid Expiration |Off |
|Customize |Force new container quantity |Off |
|Customize |Container quantity value |Blank |
|Customize |Use Catalog# to validate new |Off |
|Customize |Require department for user acct |Off |
|Customize |Use default units |On |
|Customize |Default units value |Mg |
|Customize |User container security |Off |
|Customize |Received date required |Off |
|Customize |Auto-hazard text |Off |
|Advanced |Poll network |Off |
|Advanced |Poll network value |20 |
|Advanced |Show startup errors |Off |
|Advanced |Use MSDS URL: |Off |
|Advanced |MSDS URL value |Blank |
|Advanced |Pass (MSDS search field) |Any |
|Advanced |Multiple Languages |Off |
|Advanced |Simulate Locks |Off |
|Advanced |Struct DB (path) |Blank |
|Email Notify |Include Report Viewer download |Off |
|Email Notify |Report Viewer URL |Default |
|Email Notify |Include message |Default |
|Email Notify |Message text |Default |
Global Settings (\cispro\data\cis3.ini)
[Expressions]
Expires_2=LT(TODAY+30 days)
[Defaults]
barcode_numeric=1
barcode_serial=1
barcode_min_width=6
Local Settings (File | Configure)
|Tab |Item |Setting |
|Defaults |Preview Direct Reports |Off |
|Defaults |Enable RIBM Support |Some Workstations |
|Defaults |Enable Ordering Support |Off |
|Defaults |Enable Chemoffice Support |Off |
|Defaults |ChemACX Setup (path) |Not-used |
|Labels |Report Printer |Depends on station |
|Labels |Label Printer |Eltron, depends on station |
|Labels |Barcode ID Label Setup (size) |See label addendum |
|Advanced |Enable SAF Imports |Off |
|Advanced |SAF Target |Ignored |
|Advanced |RIBM Setup (device) |Depends on station |
|Advanced |RIBM Setup (COM port) |Depends on station |
|Email Notify |Enable Email Notify |Off |
|Balance |Enable RS232 |Off |
|Balance |Type |Mettler |
|Balance |COM |Ignored |
|Balance |Parity |N |
|Balance |Timeout |250 |
|Balance |Data Bits |8 |
|Balance |Baud |9600 |
|Balance |Stop Bits |1 |
Local Settings ([windows]\cis3.ini)
See Label menu settings in Label Addendum
See RIBM menu settings in RIBM Addendum
Local Settings (Windows Defaults)
Date setting should be mm/dd/yyyy or equivalent four digit year.
Addendum E. Distribution CD Content List
SOFTWARE CONTAINED ON THE DEPLOYMENT CD FOR MERCK NASU:
Documentation
\manual
\12220man_1.doc
\cis32c.hlp
\t
\deployment\ Merck Implementation Specification.doc
\test_plans\12411\(*.xls and *.doc)
\12422\(*.xls and *.doc)
\DataFiles\*.* (All Data Files required to complete the test plans)
\didmgr
\DidMgr-v105.xls
\DidMgrTestPlan.doc
\handhelds
\cispro_pdt_inout.doc
\cispro_pdt_inout_v101.xls
\cispro_pdt_invent.doc
\cispro_pdt_invent_v101.xls
\cispro_videx_einout.doc
\cispro_videx_einout_v101.xls
\cispro_videx_einvent.doc
\cispro_videx_einvent_v101.xls
\cispro_videx_inout.doc
\cispro_videx_inout_v101.xls
\cispro_videx_invent.doc
\cispro_videx_invent_v102.xls
CISPRO Application Files
\12411\cis32ora.exe & *.* (cispro files)
CISPRO eSig Executable Replacement
\12422\cis32ora.exe
DIDMGR Application
\didmgr\didmgr.exe
\didmgr\crypt01.dll
\didmgr\reports\Audit_Main.srw
\didmgr\reports\Audit_Batch.srw
BDE Support Files
\10004\*.* (bde files)
Label Files
\labels\merck.lbl
Handheld Support Files
\Videx
pro122a.os
vxcrf.dll
\Symbol
sendhex.exe
sender.bat
Handheld Programs
\handhelds
\inout.s
\inout.ini
\invent.s
\invent.ini
\pinout.hex
\pinout.ini
\pinvent.hex
\pinvent.ini
(note: subdirectories below denote minutes idle timeout)
\2
einout.s
einout.ini
einvent.s
einvent.ini
\5
einout.s
einout.ini
einvent.s
einvent.ini
\10
einout.s
einout.ini
einvent.s
einvent.ini
\15
einout.s
einout.ini
einvent.s
einvent.ini
Appendix 3 - Network Diagram
[pic]
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