Part 11 / Annex 11 Computer Systems Validation (CSV) is implemented in order to increase the integrity, accountability and security of the spreadsheets and achieve GxP Compliance. CSV enables the level and rigor of specification and verification applied to spreadsheets to be based on spreadsheet risk, complexity, and novelty. This hands-on seminar will provide the attendees with the tools for successful computer systems validation for Excel Spreadsheets.
Spreadsheets are a very powerful and useful tool in the GxP environment especially when coupled with the fact that it is easy to build spreadsheet applications without much training. However, this results in spreadsheets being among the most under-documented systems used in GxP environments because:
Users regard them as part of the desktopThe ease with which applications can be built without much trainingThe data processing power that they can haveLack of knowledge that spreadsheets need to be validatedLack of knowledge on how to validate spreadsheets
Consequently, Spreadsheets have become low hanging fruit during FDA or other regulatory inspections and many warning letters have been issued.
Lecture 1: Types of SpreadsheetsLecture 2: Excel Validation at a High LevelLecture 3: FDA Use of Excel SpreadsheetsLecture 4: Excel Validation Master Plan (VaMP)
Lecture 5: Excel Risk Assessment & RequirementsLecture 6: Excel Functional & Design SpecificationLecture 7: Verification & Testing for Excel CSVLecture 8: Quality Assurance for Excel CSV
Laura Wood, Senior Manager
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics:Pharmaceuticals,Drug Discovery,Pharmaceutical Manufacturing
INDUSTRY KEYWORD: HEALTH PHARMACEUTICAL
SOURCE: Research and Markets
Copyright Business Wire 2018.
PUB: 05/02/2018 03:31 PM/DISC: 05/02/2018 03:31 PM
Copyright Business Wire 2018.
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