Tag: Data Governance

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EU GMP Annex 11 versus FDA 21 CFR Part 11 comparison for computerized systems and electronic records

Annex 11 vs 21 CFR Part 11: Comparison and GMP Requirements

Comparison of Annex 11 and 21 CFR Part 11, with practical takeaways on validation, governance, risk management, audit trails, electronic...
Good Documentation Practice (GDocP) in GMP, highlighting the role of structured, controlled documentation in ensuring data integrity, regulatory compliance, and trustworthy pharmaceutical records.

Good Documentation Practice (GDocP) in Pharma

A practical guide to Good Documentation Practice (GDocP) in pharma, covering ALCOA++, data integrity, inspections, electronic records, and compliance controls....
ALCOA++ in GMP: Practical Data Integrity for Labs and Manufacturing - Featured Image

ALCOA++ in GMP: Practical Data Integrity for Labs and Manufacturing

Explore ALCOA++ in GMP: practical data integrity principles that keep records accurate, traceable, and inspection-ready....
IDMP Ontology what is it and how to use it in your organization - featured image

IDMP Ontology: What It Is and How It Can Be Used in Your Organization

IDMP Ontology explained: how it supports regulatory data, improves data governance, and prepares your pharma organization for SPOR and ISO...

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