URL details: www.compliancezen.com/compliance_zen/2015/03/more-fda-data-integrity-faqs.html#comments
URL title:
Compliance Zen: More FDA Data Integrity FAQs
URL description:
FDA updated its FAQ page on Good Manufacturing Practices with several data integrity and Part 11 related questions and answers, including: Why does FDA object to using actual samples to perform system suitability testing? Why is FDA concerned with the use of shared login accounts for computerized systems? The answer to the latter should be obvious. You can't prove the authenticity of the data or hold the data owner accountable if you cannot identify who actually created or modified the data. Shared logins b
URL keywords:
FDA, part 11, data integrity, GMP, recordkeeping, data integrity consultant, data integrity auditor, data integrity help, data i
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