Suite A CIP4 Operational Qualification



[INSERT COMPANY LOGO HERE][INSERT SITE ADDRESS HERE]Project Validation Planfor the[INSERT PROJECT NAME HERE]Document # [INSERT DOCUMENT NUMBER HERE]PREPARED BY:DISCIPLINEPRINTED NAMESIGNATUREDATEValidationAPPROVALS:DISCIPLINEPRINTED NAMESIGNATUREDATEValidationITEngineeringSystem OwnerQualityTable of Contents TOC \o "1-3" \h \z \u 1Purpose PAGEREF _Toc10708853 \h 42References PAGEREF _Toc10708854 \h 43System Description PAGEREF _Toc10708855 \h 44Scope of Changes PAGEREF _Toc10708856 \h 45Definitions PAGEREF _Toc10708857 \h 46Responsibilities PAGEREF _Toc10708858 \h 47Scope of the Plan PAGEREF _Toc10708859 \h 58Validation Approach PAGEREF _Toc10708860 \h 59Ongoing System Requirements PAGEREF _Toc10708861 \h 610Validation Deliverables PAGEREF _Toc10708862 \h 611Validation Activities PAGEREF _Toc10708863 \h 712Version History PAGEREF _Toc10708864 \h 8PurposeThis project Validation Plan (VP) defines the project scope, responsibilities, testing strategy, and deliverables for the qualification of [INSERT PROJECT SCOPE] at [INSERT LOCATION], performed under [INSERT CHANGE CONTROL].References21 CFR Part 11, “Electronic Records and Electronic Signatures”21 CFR Part 211, “Current Good Manufacturing practice for finished pharmaceuticals”[INSERT INDUSTRY GUIDANCE e.g. ISPE GAMP 5, “A Risk-Based Approach to Compliant GxP Computerized Systems”][INSERT SITE POLICIES AND PROCEDURES]System Description[INSERT SYSTEM DESCRIPTION]Scope of Changes[INSERT SCOPE OF CHANGES]DefinitionsTerm or AcronymDefinitionCFRCode of Federal RegulationsGAMPGood Automated Engineering PracticesIOQInstallation and Operational QualificationISPEInternational Society of Pharmaceutical EngineersVPValidation PlanResponsibilitiesA representative from each department with responsibilities indicated below shall approve this document. Signature indicates that the project validation plan has been reviewed in its entirety and the details herein are agreed upon. Quality shall be the final approver.Each department’s responsibilities related to project deliverables are detailed in Table 1, “Responsibility Matrix for Project Deliverables” below. Approvers indicated are the minimum required approvers.Table 1: Responsibility Matrix for Project DeliverablesDocumentValidationITEngineeringSystem OwnerQuality[INSERT DELIVERABLE]D, AAAAA[INSERT DELIVERABLE]AD, AA--[INSERT DELIVERABLE]AD, AA--[INSERT DELIVERABLE]D, EAAAA[INSERT DELIVERABLE]DAAAAKey:D = Draft, E= Execute, A = ApproveScope of the PlanValidation activities will provide documented evidence to a high degree of assurance that the [INSERT PROJECT SCOPE] accurately and reliably perform the functions intended for use at [INSERT LOCATION].The scope is all changes described in section REF _Ref10636011 \r \h 3. Validation Approach[ADD/DELETE SUBSECTIONS AS APPROPRIATE]Documentation of Test ResultsAll test results shall be documented following good documentation practices per [INSERT SITE SOP].Failures to meet acceptance criteria during qualification shall be documented per [INSERT SITE SOP].CalibrationMaintenance of the Qualified StateChange Control: Change control will be followed per [INSERT SITE SOP] following approval of the IOQ final reports. Requalification: Requalification may be performed per [INSERT SITE SOP]Ongoing System Requirements[ADD/DELETE SUBSECTIONS AS APPROPRIATE]Data Retention[INSERT SITE SOP] describes the requirements and methods for retention of system/software data.Backup/RestorationDocument Retention[INSERT SITE SOP] describes the retention requirements for the validation documents.Validation Deliverables[ADD/DELETE SUBSECTIONS AS APPROPRIATE]User Requirements Specification (URS)Functional Specification (FS)Design Specification (DS)Standard Operating Procedures (SOPs)Standard Operating Procedures for the systems in scope of this plan have been written and effective. SOPs may be redlined to support OQ testing if necessary. Redlined SOPs shall be attached to the qualification protocol and any revised operating SOP shall be effective prior to system go-live. Installation and Operational Qualification (IOQ)Summary ReportsA summary report will be created and approved at the completion of each validation protocol execution to document a summary of the testing activity and the readiness of the system for further qualification or GMP use.Validation ActivitiesThe validation scope is described in Table 3, Validation Scope Activity Matrix. The matrix identifies required deliverables for each system.Table 3 – Validation Scope Activity MatrixSystem NameURSFSDSIOQ[INSERT SYSTEM NAME][INSERT SYSTEM NAME]-[INSERT SYSTEM NAME]-[INSERT SYSTEM NAME]-[INSERT SYSTEM NAME]-[INSERT SYSTEM NAME]-[INSERT SYSTEM NAME]-Version HistoryVersionDateDescription of ChangeJustification1.0[DATE]New document[Change Control #] ................
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