Electronic signatures (E-signatures) are becoming more and more commonly used in today’s world. Before electronic signatures were recognized and accepted legally, documents had to be manually signed by each of the signatories, stored and filed in squeaky compactors (compactus …
GMP Basics of Good Documentation Practices (GDocP)
Good documentation practice (GDocP) is a crucial component of regulatory compliance, including data integrity assurances.
Referred to in the industry as Good Recordkeeping Practice (GRK), the term good documentation practice generally involves adhering to …
The time has come for us to talk about the Data Integrity elephant in the GMP room. Despite Data Integrity being a hot topic in industry for the past 5 years, it continues to attract a lot of attention …
Yes, we are still talking about the very old issue of Good Manufacturing Practice Pens or GMP pens and the most suitable colour of ink for pharmaceutical manufacturing pens and other issues. The various codes simply refer to “indelible …
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 …
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 definitions are further explained with …
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 …
Data Integrity Violations
Source: Washington Post, Sept 26, 2015 – Thanks to Volkswagen
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 …
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 …
Pharmaceutical Cloud Computing
As we evaluate pharmaceutical cloud computing as an option we see pharma companies are slow to adopt cloud computing services, mainly because of the perceived data security / data integrity risk and fear of regulatory interpretations. I …
