Tag: Annex 11

Audit Trail Review in GMP: Designing a Practical, Risk-Based Program

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Audit Trail Review in GMP: Designing a Practical, Risk-Based Program Audit Trail Review in GMP: Designing a Practical, Risk-Based Program In the pharmaceutical manufacturing industry, maintaining data integrity is a foundational regulatory expectation demanded by authorities such as the FDA, EMA, and MHRA. Integral to this objective is the implementation of effective and practical audit…

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Data Integrity, ALCOA+ & Part 11 / Annex 11

Electronic Records and Signatures: Aligning EU Annex 11 and 21 CFR Part 11

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Electronic Records and Signatures: Aligning EU Annex 11 and 21 CFR Part 11 Comprehensive Guide to Electronic Records and Signatures Compliance Under EU Annex 11 and 21 CFR Part 11 Pharmaceutical manufacturers and regulatory professionals worldwide face an evolving regulatory landscape concerning the management of electronic records and signatures. Ensuring data integrity and compliance with…

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21 CFR Part 11 – Electronic Records & Signatures

Data Integrity & 21 CFR Part 11: A Step-by-Step, Inspection-Ready Guide for US/EU/UK Pharma — PharmaGMP

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Data Integrity & 21 CFR Part 11: A Step-by-Step, Inspection-Ready Guide for US/EU/UK Pharma — PharmaGMP Data Integrity & 21 CFR Part 11 — Step-by-Step, Inspection-Ready Guide Data integrity means your records are trustworthy enough for life-and-death decisions. Regulators expect records that are ALCOA+—Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available. When…

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Data Integrity & 21 CFR Part 11 Compliance

Computer System Validation (CSV): A Step-by-Step, Inspection-Ready Guide for GxP Computerized Systems — PharmaGMP

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Computer System Validation (CSV): A Step-by-Step, Inspection-Ready Guide for GxP Computerized Systems — PharmaGMP Computer System Validation (CSV) — Step-by-Step, Inspection-Ready Guide for GxP Computerized Systems Computer System Validation (CSV) ensures that GxP computerized systems are fit for purpose, consistently reliable, and capable of generating and protecting records that regulators trust. Whether you run a…

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Computer System Validation (CSV) & GxP Computerized Systems