Data Integrity

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Good Documentation Practices (GDocP) | GMP Basics

GMP Basics of Good Documentation Practices (GDocP)
Good documentation practices (GDocP) are key components of GMP compliance.  Good record-keeping not only helps you during regulatory inspections (GMP audits), it is mandatory to ensure your documentation …

data measurements

MHRA: Data Integrity defined?

In July 2016, the MHRA released a draft document for consultation entitled MHRA GxP Data Integrity Definitions and Guidance for Industry.  As the name suggests, it is a glossary of DI terms where the …

Surprised man

US FDA continue to find Data Integrity violations

Within the last 30 days, the US FDA released two new Warning Letters and yes-you guessed it, all contain data integrity violations. Lets look them below:
Falsifying test data from a stability batch
The latest Warning Letter is …

data-integrity

Ensuring Data Integrity Through ALCOA

The acronym ALCOA has been around since the 1990’s, is used by regulated industries as a framework for ensuring data integrity, and is key to Good Documentation Practice (GDP). ALCOA relates to data, whether …