How "DI healthy" are your systems? Want a Free Data Integrity Checklist?

How "DI healthy" are your systems? Want a Free Data Integrity Checklist?

Since the MHRA released their data integrity guide back in March 2015, there has been a constant drip-feed of articles, blogs, commentary, and more worryingly, more guidance on the topic of Data Integrity. Lets add a free Data Integrity Checklist to the list! The acronym “NADDIG” was jokingly introduced by Trevor in the PharmOut office….

US FDA continue to find Data Integrity violations
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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 to an API manufacturer who acknowledged to the inspector during the inspection that a laboratory analyst substituted a reference…

When good employees turn bad (or just sloppy) – controlling the 3 drivers for data integrity violations

When good employees turn bad (or just sloppy) – controlling the 3 drivers for data integrity violations

Data Integrity Violations   Data Integrity violations or data errors can happen in 3 ways: fat finger errors (an accidental lapse by an operator), falsification (a rogue operator who enters false results) and fraud (collusion by a number of people). In this blog post, we’ll investigate how to reduce the risk of all three. With…

Why is Data Integrity still a ‘hot topic’ and why do we continue to discuss it?

Why is Data Integrity still a ‘hot topic’ and why do we continue to discuss it?

The review of data is the basis of everything that we do in the industry. It is the foundation of regulatory filings, controls in manufacturing, the checks in laboratory analysis, assurance of product release and so on. We continue to discuss DI issues as they continue to appear in US FDA Warning Letters, EU non-compliance…