EMA Annex 11 Computerised Systems FAQ Q&A, 2/11

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In January, 2011, the European Commission published a new version of Annex 11, Computerised Systems with an effective date of June 30, 2011.ﾠ

The European Medicines Agency (EMA) has published answers to frequently asked Annex 11 questions.ﾠ

Topics include spreadsheet validation, data security and retention, retrospective validation, periodic review, revalidation, and small device validation.