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 in ensuring GMP compliance and successful audit findings.  Specific rules for documentation are required to meet PIC/S (quality standards and risk …

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 …