10/21/2023 0 Comments Gamp category 1 examplesTest or Verification Reference (e.g., IQ, OQ, PQ)ġ.0 Text. All rights reserved.įorms 3-5 Example forms to assist with testingįorms 6-8 Example forms to assist with the process of managing a changeįorms 9-14 Example forms to assist with document managementįorm 15 Example format for a traceability matrixįorms 16-17 Example forms to support validation reportingįorms 18-20 Example forms to support backup and restoreįorms 21-22 Example forms to support performance monitoringġ5: Example Format for a Traceability Matrix 1.URS reference numberĢ. They may be used freely within your own organization however, they remain the property of ISPE, should not be used for commercial purposes, and are not available for resale. The GAMP 5 example templates, forms, checklists, and questionnaires are provided for your convenience. ![]() Please note that while every effort has been made to provide the Microsoft® Word documents in a reusable format, ISPE does not guarantee that they will appear correctly when opened in Microsoft® Word or another word processing application. The GAMP 5 example templates, forms, checklists, and questionnaires are provided in Microsoft® Word (suitable for Microsoft® Word 2000 or above) or Adobe® PDF format. The material is indicative only and intended to be neither exhaustive nor prescriptive. Where indicated, purchasers of GAMP 5 are free to use and modify this material for internal use within their organization only. No reproduction for commercial purposes, resale, or other commercial use of the whole or any part of this material is allowed without the written agreement of ISPE. GAMP 5 Example Forms Copyright in the whole and every part of this material is owned by ISPE. Form 1 Example risk assessment form Form 2 Example source code review form Forms 3-5 Example forms to assist with testing Forms 6-8 Example forms to assist with the process of managing a change Forms 9-14 Example forms to assist with document management Form 15 Example format for a traceability matrix Forms 16-17 Example forms to support validation reporting Forms 18-20 Example forms to support backup and restore Forms 21-22 Example forms to support performance monitoring ![]() ![]() ![]()
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