Tag: GxP compliance

How to Perform a Data Integrity Risk Assessment for Critical GMP Systems Step-by-Step Guide: Performing a Data Integrity Risk Assessment for Critical GMP Systems Ensuring data integrity is a fundamental requirement within pharmaceutical Good Manufacturing Practice (GMP). Considering the regulatory mandates under 21 CFR Part 11 in the US, Annex 11 in the EU, and…

Read More “How to Perform a Data Integrity Risk Assessment for Critical GMP Systems” »

Common Data Integrity Failures in QC Labs and How to Prevent Them Understanding and Preventing Common Data Integrity Failures in QC Laboratories Data integrity is a foundation stone in pharmaceutical manufacturing and quality control. Ensuring the accuracy, completeness, and reliability of data generated in Quality Control (QC) laboratories supports compliance with GxP principles and regulatory…

Read More “Common Data Integrity Failures in QC Labs and How to Prevent Them” »

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…

Read More “Audit Trail Review in GMP: Designing a Practical, Risk-Based Program” »