Installation Qualification for E-Notebook 11 at Genzyme



Installation Qualification of

E-Notebook SQL 12.0 E-Signatures add-on

|IQ PROTOCOL ORIGINATED BY: | | |

| | |Date |

|IQ PROTOCOL UPDATED BY: | | |

| | |Date |

DOCUMENT APPROVED BY CUSTOMER

|Department |Signature/Title |Date |

|Information Technology | | |

|Technical | | |

|Validation | | |

|Quality Assurance | | |

TABLE OF CONTENTS

1. Purpose 3

2. Scope 3

3. System Description 4

3.1. Database Server Verification 4

3.2. Webserver Verification 4

3.3. E-Notebook Client Verification 4

3.4. System Overview 4

4. Responsibilities 4

4.1. CambridgeSoft (CS) 4

4.2. CS Project Manager (PM) 5

5. Definitions 5

5.1. Variance 5

5.2. Installation Qualification (IQ) 5

5.3. Acceptance Criteria 5

6. Equipment/Material Needed 5

7. Customer Prerequisites 5

8. Acceptance Criteria 5

9. General Instructions For Executing The Protocol 6

10. Approvals 6

11. Verification of the Installation/Configuration of the E-Notebook SQL 12.0 E-Signatures add-on 7

11.1. Objective 7

11.2. Acceptance Criteria 7

11.3. Client PC 7

11.3.1. Accounts/Setup required 8

11.3.2. Hardware Installation Verification for Client PC 8

11.3.3. Software Installation Verification for Client PC 8

11.4. Web Server (Middle-Tier) 9

11.4.1. Hardware Installation Verification for the Web Server 9

11.4.2. Software Installation Verification for the Web Server 10

11.5. Database Server 10

11.5.1. Hardware Installation Verification for the Database Server 10

11.5.2. Required Software for Database 11

11.5.3. Database Checklist 12

12. Protocol Report 12

12.1. Protocol Report 12

12.2. Validation Package 12

Appendix A: Signature Identification Log 14

Appendix B: Supporting Documentation 15

Appendix C: Variance Procedure And Form 15

Appendix D: Install guides for E-Notebook SQL 12.0 E-Signatures add-on 18

1. Introduction 18

2. Prerequisites 18

3. Creating a Long Term Archive (CSDocStore) Database 18

3.1. Creating a linked server Error! Bookmark not defined.

4. Setup DocStore Webserver 21

4.1. Install and configure the CSDocStore webservice. 21

4.2. Confirming the Webservices settings 23

4.3. Creating Certificates with a Private Key for CSDocStore 26

4.3.1. Checking for the issued certificates 26

4.3.2. Creating the certificates 28

4.3.3. Applying permissions to the issued certificates 30

4.4. Create CSDocStore connection configuration file 32

4.5. Confirm functioning of CSDocStore Webservice 33

5. E-Notebook Database Configuration for E-Signatures 35

5.1. Clean 12.0 database installation 36

5.2. Migrated database from E-Notebook 10.0, 11.0 or 11.5 38

6. Configure Adobe PDF printer on E-Notebook client 47

7. Enhanced Security Configuration (optional) 48

7.1. Configure CSDocStore Webservice with a domain account 48

7.1.1. IIS Server Changes 48

7.1.2. Add ‘Read’ permissions to the Windows Temp folder 54

7.1.3. Change Permissions on CSDocStore Certificates 55

7.2. Change ‘LTA User’ password 55

Purpose

Use this Installation Qualification to verify the steps for installing and configuring the E-Notebook SQL 12.0 E-Signatures add-on.

Scope

This document describes the steps required to install and configure the E-Signatures add-on for CambridgeSoft E-Notebook SQL. There are three main components to the installation:

• Create the Long-Term Archive (CSDocStore) database on a SQL Server

• Install and configure the CSDocStore webservice on an IIS server

• Import the E-Signatures configuration into the database from an E-Notebook client.

System Description

1 Database Server Verification

Verify the following:

• SQL Server Hardware

• SQL Server Configuration

2 Webserver Verification

Verify the following:

• Webserver Hardware

• Webserver Configuration

3 E-Notebook Client Verification

Verify the following:

• E-Notebook Client Hardware

• E-Notebook Client-Server Connection Configuration

4 System Overview

The system components and their specifications are:

• The system consists of a database, Web server (middle-tier), and a client connected to the network.

• The Web server operating system consists of either Windows 2003 Server R2 SP2 or Windows Server 2008 SP1 and resides on its own server (see section 11.4.2 for Web server requirements).

• The database operating system consists of either Windows 2003 R2 SP2 or Windows Server 2008 SP1 and resides on its own server (see section 11.5.2 for database server requirements).

• The database is a SQL Server database.

• The client operating system is Windows XP or Windows Vista with Microsoft Office XP, Office 2003, or Office 2007.

Responsibilities

1 CambridgeSoft (CS)

CambridgeSoft is responsible for authoring and amending this document and for executing the protocol. CS initiates a variance form as needed and as instructed by Appendix C: Variance Procedure And Form. CS records the nature of the variance and authors the installation qualification (IQ) report.

2 CS Project Manager (PM)

The CambridgeSoft project manager is responsible for ensuring that the IQ includes the installation of all needed hardware and software and formulates a resolution for variances.

Definitions

1 Variance

A variance is a recognized departure from the documented procedures.

2 Installation Qualification (IQ)

The documented verification that hardware and software are installed with respect to vendor and user requirements.

3 Acceptance Criteria

Acceptance Criteria are pre-defined requirements or tests that must be fulfilled.

Equipment/Material Needed

The software needed to install the E-Notebook SQL 12.0 E-Signature add-on is in the folder “\DataManagement Server Setup\E-Notebook” provided by CambridgeSoft.

Customer Prerequisites

• E-Notebook SQL 12.0 database installed and configured.

Note: All prerequisites for installation are included in the specific Installation Guides.

Before initiating any verification sections, the prerequisites must be completed. List and attach appropriate supporting documentation in Appendix B: Supporting Documentation.

Comments/Observations:

___

Reviewed by: ___________________________ Date:___________

Acceptance Criteria

• All IQ prerequisites are met.

• All personnel involved in executing the protocol have been properly trained. Copies of their training records are available for review.

• All acceptance criteria as defined in the IQ verification sections have been met. The installation of a validation (test) instance is complete, verified, and documented.

• All variances in the use of this protocol or in actual results from expected results have been described in a Variance Report (see Appendix C: Variance Procedure And Form). All variances are closed (complete and approved by QA /Validation).

• The system has been placed under the control of an approved change control procedure. All personnel entering data on this protocol have logged their signature in Appendix A: Signature Identification Log.

• All supporting documentation (screen prints, reports, etc.) collected during test execution has been logged in Appendix B: Supporting Documentation.

General Instructions For Executing The Protocol

1. The customer is responsible for the review and approval of this IQ prior to execution of the IQ.

2. This IQ covers the steps for installing and configuring E-Notebook SQL 12.0 E-Signatures add-on.

3. All documents produced as part of the execution of this IQ will be printed out and appended to this document as evidence of test results.

Company Name :

Facility :

Address:

Approvals

Executed IQ Approval:

|Title or Department |Name |Signature |Date |

| | | | |

| | | | |

| | | | |

*Signature identification log is in Appendix A: Signature Identification Log.

• The prerequisite items identified in the Prerequisites Section must be completed before execution of the protocol. Prerequisite items are considered completed when all items are complete and a QA representative has reviewed and signed the prerequisite section.

• All personnel entering data (execution or review) into this protocol must complete the required portion of Appendix A: Signature Identification Log.

• As each activity is completed, the individual performing the activity enters the actual results achieved, initials, and dates the entry.

• Variances in the use of this protocol or in actual results from expected results must be documented in a Variance Report as specified in Appendix C: Variance Procedure And Form.

• A reviewer must review and sign at the bottom of each page on which data is recorded as part of the execution of the protocol. This includes the Prerequisites Section and all test sections. The reviewer cannot be the same individual who performed the validation activities.

• All protocol entries are to be made using blue ballpoint indelible ink.

• Each step in the test must be executed in order.

• All test response sections must be filled in.

• All completed test steps will have a test result of Pass (Pass) or Variance/Fail (Variance).

• Variance:

o A variance is a recognized departure from the documented procedures.

o List all variants from the acceptance criterion in the variance section.

o A procedural variance may occur when a test step cannot be executed as written. In this case a workaround may be substituted into the test step with a documented variance.

o A protocol variance should be written against any test step or acceptance criteria that was written incorrectly. The correction should be documented in the variance form.

o All variances will be investigated as part of their remediation. All variances that meet the failure definition upon investigation will be documented as Fail.

• Fail:

o A protocol fails when a test step fails to meet the acceptance criteria or expected results.

o A functional failure is realized when the product does not perform with respect to the requirements.

o All failures will be recorded (as variances) and communicated, and a plan for correction will be created.

o Catalogue all attachments with the Appendix Number, reference the test and test step, sign, and date.

o Always sign and date each test procedure section as indicated and prior to moving on the next test section.

o Verify that the acceptance criterion has been met for each test step.

Verification of the Installation/Configuration of the E-Notebook SQL 12.0 E-Signatures add-on

1 Objective

The objective of this test is to establish the correct installation of E-Notebook SQL 12.0 E-Signatures add-on.

2 Acceptance Criteria

Actual results must match or exceed expected results for all items.

3 Client PC

1 Accounts/Setup required

|# |Item |Actual |Initial/Date |

| |An E-Notebook installation that is configured to connect to an E-Notebook | | |

| |database. | | |

| |An E-Notebook Administrator user account and password are known and | | |

| |available to import the E-Signature add-on. | | |

|Conclusion re. Client installation |Pass ( | |

| |Variance ( | |

2 Hardware Installation Verification for Client PC

Logon ID used:_____________________________________

|# |IQ Item |Specification/ |Actual Result |Initial/ |

| | |Expected Result | |Date |

| |Memory |1GB (min), 2GB (preferred) |RAM: | |

| |(RAM) | | | |

| | | |Specification met: | |

| | | |Yes ( No ( | |

| |Processor type |1 CPU: |Processor Type: | |

| | |1.6 GHz or higher Pentium 4 |Serial #: | |

| | |1.6 GHz or higher Intel Core Duo | | |

| | | |Specification met: | |

| | | |Yes ( No ( | |

| |Available HDD Capacity|300MB – 2GB (offline use of E-Notebook varies the space | | |

| | |required) | | |

3 Software Installation Verification for Client PC

Logon ID used:_________________________________________

|# |IQ Item |Specification/ |Actual Result |Initial/ |

| | |Expected Result | |Date |

| |Client Operating system |Windows XP Professional SP2/SP3 32-bit |Version: | |

| | |Windows Vista Business SP1/SP2 32-bit | | |

| | | |SP: | |

| |.NET Framework |. NET Framework 2.0 SP2 | | |

| |Microsoft Office |Office XP SP3, Office 2003 SP3, Office 2007 SP1 |Version: | |

| | | | | |

| | | |SP: | |

| |Adobe Acrobat |8.1 Standard or Professional |Version: | |

| | |9.1 Standard or Professional | | |

| | | |Standard/Professional: | |

| |ChemDraw plug-in* |ChemDraw ActiveX Const11 version 12 |ChemDraw: | |

| |MolServer.dll |MolServer.dll Const11 version 12 | | |

| | |E-Notebook client 12 |Version: | |

| |E-Notebook client | | | |

| |*This is provided separately as part of Chem(Bio)Office Core with Serial number override. It is not necessary to install if full| |

| |ChemBioOffice Desktop is already present. | |

|Conclusion re. Server installation |All tests of the configuration meet expected results; the |Pass ( | |

| |server processor and memory are properly configured. |Variance ( | |

4 Web Server (Middle-Tier)

1 Hardware Installation Verification for the Web Server

Logon ID used (for the server manager):_____________________________________

|# |IQ Item |Specification/ |Actual Result |Initial/ |

| | |Expected Result | |Date |

| |Processor |1.6GHz dual processor or higher | | |

| |Available HDD Capacity |15 - 20GB | | |

2 Software Installation Verification for the Web Server

Logon ID used:_____________________________________

|# |IQ Item |Specification/ |Actual Result |Initial/ |

| | |Expected Result | |Date |

| |Operating system level: |Standard or Enterprise Edition | | |

| |Operating system |32-bit (64-bit is NOT supported) | | |

| |architecture: | | | |

| |Internet Information |IIS 6.0 or IIS 7.0 | | |

| |Services (IIS)* | | | |

| |* This must be installed and running. To confirm: | |

| |go to Control Panel>Administrative Tools> | |

| |Internet Services Manager and ensure that “Default Web Site” is started. | |

| |‘IUSER_’ (win2003) or ‘IUSR’ (win2008) available | |

| |.Net Framework: |.Net Framework 2.0 | | |

5 Database Server

1 Hardware Installation Verification for the Database Server

Logon ID used (for the server manager):_____________________________________

|# |Procedure |Specification/ |Actual Result |Initial/ |

| | |Expected Result | |Date |

| |Note Server Name |Validation Database Server: | | |

| | | | | |

| | |Production Database Server: | | |

| |Server processor |2 Intel Xeon CPUs |Processor 1: | |

| |type | |Type: | |

| | | |Serial #: | |

| |Identify the | | | |

| |number and type(s)| |Processor 2: | |

| |of CPU(s). | |Type: | |

| | | |Serial #: | |

| | | | | |

| | | |Specification met: | |

| | | |Yes ( No ( | |

| |Server processor |Processor 1, serial number |Processor 1: | |

| |logical quantities| | | |

| | |____________, 2 partitions |Serial #: | |

| |The number of | | | |

| |partitions for |Processor 2, serial number |Number of partitions:_______ | |

| |each CPU | | | |

| | |____________, 4 partitions |Processor 2: | |

| | | | | |

| | | |Serial #: | |

| | | |Number of partitions:_______ | |

| | | | | |

| | | |Specification met: | |

| | | |Yes ( No ( | |

| |Memory (RAM) |Note the RAM. | | |

| | |4GB (min), 16GB (preferred) | | |

| |HDD Free Space |Note the Hard Disk Space | | |

| |Required |500-1000MB/User/Year (50 GB min) | | |

| |CPU speed and |1.8 GHz to 2.8 GHz, at least 512KB cache |Processor 1: | |

| |cache size | |Speed: | |

| | | |Cache size: | |

| |Speed > 1000Mhz | | | |

| | | |Processor 2: | |

| | | |Speed: | |

| | | |Cache size: | |

| | | | | |

| | | |Processor 3: | |

| | | |Speed: | |

| | | |Cache size: | |

| | | | | |

| | | |Specification met: | |

| | | |Yes ( No ( | |

|Conclusion re. Server |All tests of the configuration meet expected results; the server |Pass ( | |

|installation |processor and memory are properly configured. |Variance ( | |

2 Required Software for Database

|# |Item |Expected |Actual |Initial/ |

| | | | |Date |

| |Operating System |Windows 2003 R2 SP2 or Windows Server 2008 | | |

| | |SP1 | | |

| | |Standard or Enterprise | | |

| | |32-bit or 64-bit | | |

| |SQL Server |SQL Server 2005 SP2/SP3 or SQL Server 2008 | | |

| | |Standard or Enterprise | | |

| | |32-bit or 64-bit | | |

| |NET Framework |.NET Framework 2.0/3.5 (depending on SQL | | |

| | |version) | | |

|Conclusion re. Server installation |All tests of the configuration meet expected |Pass ( Variance ( | |

| |results; the server processor and memory are | | |

| |properly configured. | | |

3 Database Checklist

|# |Item |Actual |Initial/Date |

| |The SQL Server instance name |Instance Name: | |

| |The “sa” user account password is known, and the password is available | | |

| |during installation | | |

| |Ensure that the database system is available on the domain and accessible to| | |

| |other systems (the firewall must be configured to allow SQL traffic out). | | |

| |. | | |

|Conclusion re. Server installation |Pass ( Variance ( | |

Protocol Report

1 Protocol Report

Prepare a Protocol Report that summarizes the results of the IQ. The report includes these sections:

• Purpose

• Scope

• References

• Analysis of Results

• Conclusion

2 Validation Package

Compile a Validation Package for each IQ that is formatted as follows:

• Final Approval Page

• Protocol Report Master (unexecuted)

• Protocol Executed (working copy)

• Protocol with all applicable attachments

Appendix A: Signature Identification Log

All personnel involved in the execution or review of this protocol must complete a row in the following table.

|Name (Print) |Signature |Initials |Company Affiliation |Date |

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Appendix B: Supporting Documentation

• Attached all supporting documentation, including non-secured documentation, screen printouts, reports, collected during test execution.

• Affixed to a blank page any item smaller than this page.

• Labeled each attached page with:

o The document number of the validation protocol.

o A cross-reference to the test step and page number to which it pertains.

o A unique page number for each attachment, e.g., 1 of 3, 2 of 3, 3 of 3.

o The initials of the person who attached it and the date of entry.

• List the attachments below:

|Attachment # |Title |# of pages |Signature |

| | | | |

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Appendix C: Variance Procedure And Form

Each variance must be documented in a Variance Report with a unique variance reference number.

• A single Variance Report may handle multiple occurrences of identical error conditions. Each occurrence of the error must be recorded, initialed, and dated by the observer in the executed protocol(s) at all procedural steps where the error applies.

• The person executing the protocol who encountered the variance labels the Variance Report with:

o The title, document number, and revision of the protocol to which it pertains.

o Variance number for that protocol (example: “2 of 4”).

o A reference to the page number and test step number of all occurrences of the error.

o A unique page number for that variance report (example: “1 of 2”).

• The person executing the protocol who encountered the variance fills in the “Observation” section, prints his or her name, signs and dates it. In the “Observation” section, they describe the error in the protocol, the problem encountered, or the difference between the Expected Results and the Actual Result.

• The CambridgeSoft Project Manager (as appropriate) records their conclusion concerning the impact of the variance on the system’s ability to reliably meet user requirements, and after discussion with the system owner, signs the “Conclusion/Impact” section. Changes to be made to the user requirements, or limits on system use, are indicated.

• The QA/Validation representative reviews the Variance and, if in agreement with the Resolution and Conclusion/Impact, approves the report by signing the “Approved By” space under the Conclusion/Impact section.

• Approved Variance Reports (or copies) are attached to the Variance Report.

PROTOCOL NAME: _______________________________________________________________

PROTOCOL #: ____________ REVISION______ VARIANCE REPORT (VR) #:______________

LOCATION OF VARIANCE: Page #_____________ Test Step #: ____________VR page #

|OBSERVATION: |

| |

| |

|By: | | | | | |

| |(name) | |(signature) | |(date) |

|RESOLUTION: |

| |

| |

| |

|By: | | | | | |

| |(name) | |(signature) | |(date) |

|By: | | | | | |

| |(name) | |(signature) | |(date) |

|CONCLUSION/IMPACT: |

| |

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|By: | | | | | |

| |(name) | |(signature) | |(date) |

|Approved By: | | | | | |

| |(name) | |(signature) | |(date) |

Appendix D: Install guides for E-Notebook SQL 12.0 E-Signatures add-on

Introduction

This document includes steps to install and configure the CambridgeSoft E-Notebook SQL 12.0 E-Signatures add-on. The installation procedure has three main components:

1. Installation and configuration of the E-Notebook database on SQL Server

2. Installation and configuration of E-Notebook Web service on the IIS middle-tier system

3. Configuration of the E-Notebook client to connect to the Web service

Prerequisites

Review and complete the checklists in section 11.5.3 before installation.

Creating a Long Term Archive (CSDocStore) Database

|Step |User Input/Action |Expected Results |Actual Results |Initial/Date |

| |Browse into the “\DataManagement Server | | | |

| |Setup\E-Notebook\Add-Ons\E-Signatures” folder | | | |

| |and select the ‘DocStore Database Setup’ | | | |

| |folder that is appropriate for your SQL Server| | | |

| |version. | | | |

| |Run ‘SetupCsltaDB.exe’. |The dialog box below appears: |  |  |

| |[pic] |  |  |

| |From the drop-down list select the name of | | | |

| |the SQL Server instance that hosts your | | | |

| |E-Notebook database. | | | |

| |Enter the proper administrative credentials | | | |

| |to connect to this SQL Server instance. | | | |

| |Enter the E-Notebook database name that you | |  |  |

| |want to use with the E-Signatures add-on and| | | |

| |click OK. | | | |

| |Select the instance name of the local SQL | |  |  |

| |server that you want to use to create the | | | |

| |Long-Term Archive (LTA) database. | | | |

| |Provide proper administrative credentials to| |  |  |

| |login to this SQL Server instance. | | | |

| |Choose a name and path for the LTA database.| | | |

| |Note: If the LTA database is created on a different SQL Server instance than that of the E-Notebook database, | |

| |a ‘linked server’ needs to be created. This linked server allows the ‘LTA User’ access to a limited view | |

| |defined within the E-Notebook database. | |

| |(Optional, see the note above) Enter a name | |  |  |

| |for the linked server. | | | |

| |Change the username and/or password for the | |  |  |

| |LTA database owner (CS_LTA) and LTA user | | | |

| |(CS_LTA_USER). The pre-filled password is the | | | |

| |same as the username. | | | |

| |Change the name of the ‘LTA User Role’ or | |  |  |

| |leave it at the pre-filled default. | | | |

| |[pic] | |

| |Click OK. |The LTA database will be created and two confirmation | | |

| | |dialogs will be seen. | | |

| | |[pic] | | |

| | | | | |

| | |[pic] | | |

|Conclusion re. A long term archive (CSDocStore) Database|All tests of the configuration meet |Pass ( | |

|is created |expected results. |Variance ( | |

Setup DocStore Webserver

1 Install and configure the CSDocStore webservice.

| Step |User Input/Action |Expected Results |Actual Results |Initial/Date |

| |Browse into the “\DataManagement Server | |  |  |

| |Setup\E-Notebook\Add-Ons\E-Signatures\DocStor| | | |

| |e Application Server\DocStore WebService” | | | |

| |folder. | | | |

| |Run |The Welcome screen appears. | | |

| |‘CambridgeSoft_ENotebook_CSDocStore_WebServic| | | |

| |e_12.01.msi’. | | | |

| |[pic] | | |

| |Click Next. |The screen below appears. |  |  |

| |[pic] | | |

| |Choose whether you accept the license |The screen below appears. |  |  |

| |agreement. If you have chosen to accept | | | |

| |the agreement, click Next. | | | |

| |[pic] | | |

| |Click Next. |The screen below appears. |  |  |

| |[pic] | | |

| |Click Install. |The screen below appears. | | |

| |[pic] | | |

| |Wait for the installation to finish and click|The completion screen appears. | | |

| |Next. | | | |

| |[pic] | | |

| |Click Finish. |The completion screen closes and the| | |

| | |installation is completed | | |

| | |successfully. | | |

|Conclusion re. The CSDocStore webservice is installed |All tests meet expected results. |Pass ( | |

|and configured. | |Variance ( | |

2 Confirming the Webservices settings

The CSDocStore Webservice installer attempts to set the correct properties for the webservice but it is good to confirm the setting. The two important settings are:

• Authentication method is set to allow anonymous access

• version is set to 2.0.x (with ‘x’ being the actual .Net 2.0 build that is installed on your system

The below steps are for a Windows 2003 Server with IIS6.

| Step |User Input/Action |Expected Results |Actual Results |Initial/Date |

| |Go to All Programs>Administrative Tools and | |  |  |

| |run the Internet Information (IIS) Manager. | | | |

| |[pic] | |

| |Browse to the CSDocStore Web site and open | |  |  |

| |the properties. | | | |

| |[pic] | | |

| |Select the Directory Security tab and click | |  |  |

| |the Edit button for Authentication and access| | | |

| |control. | | | |

| |[pic] | | |

| |Enable anonymous access should be checked | |  |  |

| |using the IUSR_MACHINE account. All forms of | | | |

| |authenticated access should be unchecked. | | | |

| |[pic] | | |

| |On the tab, make sure that the | | | |

| | version is set to use the .Net | | | |

| |Framework 2.0 (2.0.xxxx) | | | |

| |[pic] | | |

| |Click OK. | | | |

| |Note: On Windows 2003 if you installed IIS after the Microsoft .Net Framework 2.0 was installed, you need to | |

| |repair the IIS mapping. See for more information. | |

|Conclusion re. Running Web service installer |All tests meet expected results. |Pass ( | |

| | |Variance ( | |

3 Creating Certificates with a Private Key for CSDocStore

If you don't have the two certificates with a private key for the CSDocStore Webservice already (one to encrypt data to be sent to the server and one to be used for signing E-Notebook pages), they need to be created. Make sure that the certificates do not already exist. There should be one and only one certificate issued to "CS DocStore Exchange" and one issued to "CS DocStore Signature".

1 Checking for the issued certificates

Follow the steps below to determine whether the certificates already exist.

| Step |User Input/Action |Expected Results |Actual Results |Initial/Date |

| |Open Internet Explorer and select Internet |This screen shown below appears: | | |

| |Options from the Tools menu. Click the | | | |

| |Content tab. | | | |

| |[pic] | | |

| |Click Certificates and then the Trusted |The Certificates dialog box appears. |  |  |

| |Root Certification Authorities tab. Look | | | |

| |for certificates issued to: | | | |

| |CS DocStore Exchange | | | |

| |CS DocStore Signature | | | |

| |[pic] | |

| |If neither of these certificates exists, | |  |  |

| |follow the instructions in section 4.3.2 to | | | |

| |create the certificates. | | | |

2 Creating the certificates

If the certificates do not exist, follow the steps below to create them.

| Step |User Input/Action |Expected Results |Actual Results |Initial/Date |

| |Browse into the folder “\DataManagement | | | |

| |Server | | | |

| |Setup\E-Notebook\Add-Ons\E-Signatures\DocStor| | | |

| |e Application Server\DocStore Certificates” | | | |

| |Run ‘CSDocStoreCertificate.exe’. |The dialog box below appears. | | |

| |[pic] | |

| |Click Create. |The message below appears. | | |

| |[pic] | | |

| |Click OK. |The two certificates are now listed | | |

| | |under the ‘Trusted Root | | |

| | |Certification Authorities’ as shown | | |

| | |below: | | |

| |[pic] | |

3 Applying permissions to the issued certificates

The user or service account, under which the CSDocStore webservice is running, needs to have read permissions to these two certificates.

Follow the steps below to apply the permissions

| Step |User Input/Action |Expected Results |Actual Results |Initial/Date |

| |Browse to the folder where the certificates | | | |

| |are created. | | | |

| |On Windows 2003 Server this will be: | | | |

| |C:\Documents and Settings\All | | | |

| |Users\Application Data\ | | | |

| |Microsoft\Crypto\RSA\MachineKeys\ | | | |

| |On Windows 2008 Server this will be: | | | |

| |C:\ProgramData\ | | | |

| |Microsoft\Crypto\RSA\MachineKeys\ | | | |

| | Note: The [AppData] folder is, by default, hidden on the Windows OS. | |

| |Sort the files by date so that it is easier | | | |

| |to see what the two certificates are that | | | |

| |were just created (the name will differ on | | | |

| |different systems) | | | |

| |[pic] | |

| |Select the last two created files (the two CSDocStore| | | |

| |certificates) and from the right click context menu | | | |

| |select Properties. Go to the Security tab. Click Add | | | |

| |and add the following user account: | | | |

| |Network Service (or the user account under which the | | | |

| |CSDocStore webservice runs if it was changed from the| | | |

| |default) | | | |

| |[pic] | | |

| |Add ‘read’ permissions on the certification files (default) of the user account| | |

| |that was added. | | |

| |[pic] | | |

|Conclusion re. Read permissions are applied. |All tests meet expected results. |Pass ( | |

| | |Variance ( | |

4 Create CSDocStore connection configuration file

The CSDocStore webservice needs to be configured with the proper entries to be able to connect to the database on the SQL Server. These settings are maintained in the ‘CSDocStoreConfig.xml’ file in:

[AppData]\CSDocStore

On Windows 2003 Server this will be:

C:\Documents and Settings\All Users\Application Data\CSDocStore

On Windows 2008 Server this will be:

C:\ProgramData\CSDocStore

Note that the [AppData] folder is, by default, hidden on the Windows OS.

| Step |User Input/Action |Expected Results |Actual Results |Initial/Date |

| |Browse into the “\DataManagement Server | | | |

| |Setup\E-Notebook\Add-Ons\E-Signatures\DocStore | | | |

| |Application Server\DocStore Configuration” | | | |

| |folder. | | | |

| |Run ‘DocStoreSetup.exe.’ | |  |  |

| |[pic] | | |

| |Enter the name of the computer that has the SQL | | | |

| |Server with the LTA database. | | | |

| |Enter the SQL Server instance under which the | | | |

| |LTA database runs. | | | |

| |Enter the name of the LTA database. | |  |  |

| |Enter the user ID and password for the LTA USER | |  |  |

| |account. | | | |

| |Click OK. |The dialog box below appears, | | |

| | |confirming the configuration file | | |

| | |was saved. | | |

| |[pic] | | |

5 Confirm functioning of CSDocStore Webservice

| |In the main IIS manager screen click the | | | |

| |‘CSDocStore’ service. | | | |

| |[pic] | |

| |In the right pane, right-click on |A new browser window should be | | |

| |‘CSDocStore.asmx’ and from the context menu |opened with the DocStoreService page| | |

| |select ‘Browse’. |showing. | | |

| |[pic] | |

| |Click the CountDocuments link, which will | | | |

| |display the sample page. | | | |

| |[pic] | |

| |To test whether the connection to the |A new browser window will be | | |

| |LTA database is successful, click |opened, showing an xml string | | |

| |Invoke. |that contains the number of | | |

| | |submitted documents. | | |

| |[pic] | |

|Conclusion re. If the xml with the amount of submitted |All tests meet expected results. |Pass ( | |

|documents is displayed, the CSDocStore webservice is | |Variance ( | |

|functioning. | | | |

E-Notebook Database Configuration for E-Signatures

For users to be able to use the E-Signatures options in the E-Notebook client, the database has to be configured accordingly. This configuration has to be done through a Notebook client (either remote or local if it was installed on the SQL Server).

1 Clean 12.0 database installation

| Step |User Input/Action |Expected Results |Actual Results |Initial/Date |

| |Copy the contents of the folder “\DataManagement Server | |  |  |

| |Setup\E-Notebook\Add-Ons\E-Signatures\Client Configuration” | | | |

| |to the Notebook client system. | | | |

| |Launch the E-Notebook client and login as an E-Notebook | |  |  |

| |administrator. | | | |

| |[pic] | | | |

| |In the collection tree, browse up to Everyone. Right-click | | | |

| |the Configuration collection and select Import. | | | |

| | [pic] |  |

| |Browse to the location where the contents of the folder | | | |

| |Client Configuration were copied to, select ImportPro.xml and| | | |

| |click Open. | | | |

| |[pic] | |

| |Enter the name of the server that has hosts the CDDocStore | | | |

| |webservice. | | | |

| |[pic] | | |

| |Select whether a witness is required for Biology and | | | |

| |Chemistry Notebook pages that are getting signed (based on | | | |

| |the type of transition). | | | |

| |[pic] |[pic] |

| |[pic] |[pic] |

| |[pic] |[pic] |

| |[pic] |[pic] |

| |Note: After all the selections are made, the import starts and can be monitored by looking at the E-Notebook | |

| |status bar. | |

| |[pic] | |

| |Note: When you browse to the ‘E-Signatures’ ‘Rendering Folder’ under ‘shared configuration’ it is possible | |

| |you see some errors because of a previously cached version on the computer you are working on. In that case, | |

| |close the E-Notebook client, browse to the temp folder of the user that is logged in and delete the following| |

| |two folders: | |

| |ENOffline | |

| |E-Notebook | |

| |After logging back in, the errors should no longer be seen. | |

|Conclusion re. |All tests meet expected |Pass ( | |

| |results. |Variance ( | |

2 Migrated database from E-Notebook 10.0, 11.0 or 11.5

Making the E-Signatures add-on functional with a database that was migrated from a previous E-Notebook SQL version is more complicated and usually requires in depth-knowledge of how to configure E-Notebook. Since most older databases have some form of custom configuration, it is not possible to create a general procedure that will work for everybody. It is highly recommended that CambridgeSoft Services be purchased to properly configure the E-signatures add-on for migrated databases.

This document will go over one specific scenario for an E-Notebook SQL 11.0 database that was cleanly installed and then migrated to version 12.0.

| Step |User Input/Action |Expected Results |Actual Results |Initial/Date |

| |Copy the contents of the folder “\DataManagement Server | | | |

| |Setup\E-Notebook\Add-Ons\E-Signatures\Client Configuration”| | | |

| |to the Notebook client system. | | | |

| |Login to the migrated database with ‘ELNAdmin’. | |  |  |

| |Expand the ‘Users’ group collection. | | | |

| |Expand the ‘Shared Configuration’ collection. | | | |

| |Expand the ‘Rendering Folder’ collection. | |  |  |

| |Right click on ‘Document Settings’ and from the context | |  |  |

| |menu select ‘Delete’. | | | |

| |[pic] | |

| |Confirm that you want to delete the folder. | | | |

| |[pic] | | |

| |Browse up to the ‘Everyone’ collection. | | | |

| |Expand the ‘Configuration’ collection. | | | |

| |Expand the ‘Rendering Folders’ collection. | | | |

| |Expand the ‘Rendering Folder US’ collection. | | | |

| |Right click on ‘Document Settings’ and from the context | | | |

| |menu select Copy. | | | |

| |[pic] | | |

| |Expand the ‘Users’ group collection. | | | |

| |Expand the ‘Shared Configuration’ collection. | | | |

| |Right click on ‘Rendering Folder’ and from the context menu| | | |

| |select Paste. | | | |

| |[pic] | | |

| |Browse to Everyone>Configuration>Rendering | | | |

| |Folders>Rendering Folder US. | | | |

| |Right-click Section Types and, from the context menu, | | | |

| |select Copy. | | | |

| |[pic] | | |

| |Browse to Everyone>Users>Shared Configuration. | | | |

| |Right-click on Rendering Folder and, from the context menu,| | | |

| |select Paste. | | | |

| |[pic] | | |

| |Right-click on the newly pasted folder named ‘Section Types| | | |

| |2’ and, from the context menu, select Rename. | | | |

| |Change the name to ‘Page Section Types’. | | | |

| |[pic] | | |

| |Right-click Section Types and, from the context menu, | | | |

| |select Delete. | | | |

| |Confirm deletion. | | | |

| |[pic] | | |

| |Right-click Page Section Types and from the context menu | | | |

| |select Copy. | | | |

| |Right-click Rendering Folder and from the context menu | | | |

| |select Paste Reference. | | | |

| |[pic] | | |

| |Change the name of the pasted reference to ‘Section Types’.| | | |

| |[pic] | | |

| |For each existing user, browse to: ‘[username] >User | | | |

| |Configuration. | | | |

| |Right-click Rendering Folder and, from the context menu, | | | |

| |select Delete. | | | |

| |[pic] | | |

| |Confirm deletion. | | | |

| |[pic] | | |

| |Browse to Users>Shared Configuration. | | | |

| |Right-click Rendering Folder and from the context menu | | | |

| |select Copy. | | | |

| |[pic] | | |

| |For each user, right-click User Configuration and from the | | | |

| |context menu select Paste Reference. | | | |

| |[pic] | | |

| |In the collection tree, browse up to Everyone. Right-click | | | |

| |the Configuration collection and select Import. | | | |

| |[pic] | | |

| |Browse to the location where the contents of the folder | | | |

| |‘Client Configuration’ were copied to, select | | | |

| |‘ImportPro.xml’, and click Open. | | | |

| |[pic] | | |

| |Enter the name of the server that has hosts the CDDocStore | | | |

| |webservice. | | | |

| |[pic] | | |

| |Select whether a witness is required for Biology and | | | |

| |Chemistry Notebook pages that are getting signed (based on | | | |

| |the type of transition) | | | |

| |[pic] |[pic] | |

| |[pic] |[pic] |

| |[pic] |[pic] |

| |[pic] |[pic] |

| |Note: After all the selections are made, the import starts and can be monitored by looking at the E-Notebook status bar. | |

Configure Adobe PDF printer on E-Notebook client

For all clients who want to use the E-Signatures functionality, it is required that Adobe Acrobat Std or Pro is installed. The PDF printer on these clients needs to have the option 'Rely on System Fonts only: do not use document fonts' unchecked.

| Step |User Input/Action |Expected Results |Actual Results |Initial/Date |

| |Open the Printers folder from the Control | | | |

| |Panel. | | | |

| |Right-click the Adobe PDF printer and from | | | |

| |the context menu select Preferences. | | | |

| |Uncheck Rely on System Fonts only: do not use| | | |

| |document fonts. | | | |

| |[pic] | |

Enhanced Security Configuration (optional)

The above installation and configuration of the LTA database and CSDocStore webserver uses default settings that can be applied on most systems. However, some environments require more tied-down security settings.

1 Configure CSDocStore Webservice with a domain account

1 IIS Server Changes

First, the domain account needs to have the relevant permissions set.

| Step |User Input/Action |Expected Results |Actual Results |Initial/Date |

| |Open a command prompt by going to Start>Run | | | |

| |and type: cmd . | | | |

| |Browse to | | | |

| |“C:\WINDOWS\\Framework\v2.0.x” | | | |

| |where ‘x’ is the exact version number of your| | | |

| |.Net Framework. | | | |

| |[pic] | | |

| |Run the following command where | | | |

| |‘domain\userName’ is the name of your domain | | | |

| |with the domain user account you want the IIS| | | |

| |service account to use: | | | |

| |aspnet_regiis.exe -ga domain\userName | | | |

| |Note: On Windows 2003, running the Aspnet_regiis.exe -ga command adds the account to the IIS_WPG group. On | |

| |Windows 2008, the user is added to the IIS_IUSRS group. Membership in these groups grants the account the Log on | |

| |as a batch job permission and ensures that the necessary file system and IIS metabase permissions are granted. | |

| |From the Control Panel run the ‘Local | | | |

| |Security Policy’. | | | |

| |From User Rights Assignment, select Deny log | | | |

| |on locally and add the domain account. | | | |

| |[pic] | |

| |[pic] | | |

The application pool under which the CSDocStore webservice is running determines what service account is used. If no other webservices are running on the IIS server the changes can be made to the ‘DefaultAppPool’, otherwise it is best to create a new application pool specific for the CSDocStore webservice.

| Step |User Input/Action |Expected Results |Actual Results |Initial/Date |

| |Launch IIS Manager and right-click | | | |

| |Application Pools. | | | |

| |From the context menu select New>Application | | | |

| |Pool. | | | |

| |[pic] | |

| |Give a name to the new pool that will be used| | | |

| |for the CSDocStore webservice. | | | |

| |[pic] | | |

| |Right-click the newly created application | | | |

| |pool and, from the context menu, select | | | |

| |Properties. | | | |

| |[pic] | |

| |Go to the Identity tab and click the | | | |

| |Configurable radio button. Enter the domain | | | |

| |account and password. Click OK and confirm | | | |

| |the password. | | | |

| |[pic] | | |

| |[pic] | | |

| |Expand Web Sites>Default Web Site and | | | |

| |right-click CSDocStore. From the context menu| | | |

| |select Properties. | | | |

| |[pic] | |

| |On the Virtual Directory tab, select the | | | |

| |newly created application pool from the | | | |

| |drop-down list. | | | |

| |[pic] | | |

| |In a command prompt type ‘iisreset’ to | | | |

| |restart the IIS server and have the changes | | | |

| |take effect. | | | |

| |[pic] | | |

|Conclusion re. IIS Server Changes | |Pass ( | |

| | |Variance ( | |

2 Add ‘Read’ permissions to the Windows Temp folder

When invoking the CSDocStore webservice, temporary files are created in the Windows temp folder. The newly assigned domain service account needs to have write access to this folder to create these files.

| Step |User Input/Action |Expected Results |Actual Results |Initial/Date |

| |Browse to “C:\WINDOWS” and right-click the | |  |  |

| |‘Temp’ folder. From the context menu select | | | |

| |Properties. On the Security tab, click the | | | |

| |Add button and add the domain account. Give | | | |

| |the account ‘modify’ permissions. | | | |

| |[pic] |  |  |

|Conclusion re. The Windows Temp file has Write | |Pass ( | |

|permissions. | |Variance ( | |

3 Change Permissions on CSDocStore Certificates

The new CSDocStore service account needs to have read access to the "CS DocStore Exchange" and "CS DocStore Signature" certificates that were created in the Windows certificates folder in section 4.3. This can be done by either deleting the certificates and re-create them as described in section 4.3, or only change the file permissions to give full control to the domain account. Since the name of the two certificates will be different on each system it might be difficult to determine which ones the CSDocStore certificates are if more certificates were added on the computer. In that case, it is recommended to delete the certificates from Internet Explorer and re-create them.

| Step |User Input/Action |Expected Results |Actual Results |Initial/Date |

| |Browse to “C:\Documents and Settings\All | |  |  |

| |Users\Application | | | |

| |Data\Microsoft\Crypto\RSA\MachineKeys”. | | | |

| |Find the two certificates. | |  |  |

| |Go to the security settings and give ‘Read’ | | | |

| |permissions to the domain account. | | | |

| |Note: After making all the changes to the CSDocStore webservice, it is recommended that the steps in section | |

| |4.5 are followed to confirm the service is functioning. | |

|Conclusion re. CSDocStore certificates have Read access.|All tests meet expected results. |Pass ( | |

| | |Variance ( | |

2 Change ‘LTA User’ password

During the database creation process two users are created in the SQL Server logins; the ‘LTA Database Owner’ and ‘LTA User’. Only the ‘LTA User’ (with password) is used during the creation of signed E-Notebook pages. The password is stored as an encrypted string in the CSDocStoreConfig.xml file (in “[appdata]\CSDocStore” on the webserver) in the tag.

Whenever the password for the LTA User is updated on the SQL server it is essential that the encrypted password in the CSDocStoreConfig.xml file is also updated. The same application is used as in section 4.4 to update the CSDocStoreConfig.xml file.

| Step |User Input/Action |Expected Results |Actual Results |Initial/Date |

| |On the webserver, browse into the | |  |  |

| |“\DataManagement Server | | | |

| |Setup\E-Notebook\Add-Ons\E-Signatures\DocStor| | | |

| |e Application Server\DocStore Configuration” | | | |

| |folder. | | | |

| |Run ‘DocStoreSetup.exe’ | | |  |

| |Note: The current values will be read in from the CSDocStoreConfig.xml file so only the new password should | |

| |have to be entered. But it is recommended that the values are checked. | |

| |Confirm the name of the computer that has the| | | |

| |SQL Server with the LTA database. | | | |

| |Confirm the SQL Server instance under which | | | |

| |the LTA database runs. | | | |

| |Confirm the name of the LTA database. | | | |

| |Enter the user ID and new password for the | | | |

| |‘LTA USER’ account. | | | |

| |[pic] | | |

| |Click OK. |A dialog appears, confirming the | | |

| | |modified configuration file was | | |

| | |saved. | | |

| |[pic] | | |

|Conclusion re. The LTA User password is changed. |All tests meet expected results. |Pass ( | |

| | |Variance ( | |

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