How long must executed batch records be retained?
Executed batch records are retained for at least one year after the expiry date of the batch, and never less than five years from release.SOP-QA-014 §6.2
6.1 Records listed in Annex A are controlled documents. 6.2 Executed batch records shall be retained for a minimum of one year after the expiry date of the batch, and in no case less than five years from the date of batch release. 6.3 Retention periods for electronic records apply equally to their audit trails.
Which supplier was audited in the third quarter?
No answer. The documents provided do not contain this information.no source · refused
Nothing is shown here because nothing was cited. The system does not fill the gap with a plausible sentence.
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About the founderIn development: an AI-in-Quality decision assessment and a GxP document Q&A system. See projects
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Every answer shows the document it came from.
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When the source is not there, it says so.