Only some days are left before the updated revision of Annex 15 will come into operations.
Did you apply a quality risk management approach used for qualification and validation activities in the meantime?
Have you implemented validation protocols which defines the critical systems, attributes and parameters and the associated acceptance criteria?
Did you implement a reference to the current EMA guideline on Process Validation?
What about Verification of Transportation? Or how are systems and /or equipment mapped between Qualification acc. Annex 15 and Computer Validation acc. Annex 11.
From the 1. October the new Annex 15 will be used as the reference for inspections. Make sure that your internal processes, SOPs, definitions, and approaches are in compliance with the new requirements of EU Annex 15 for Qualification and Validation.
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