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 – the constant discussion generating more questions than answers, and creating confusion over what does and…
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 to some) held within a rather dark records room. Obviously, this process is very time consuming…
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 ALCOA+ principles. GRK/GDocP is mandatory to ensure that your documentation — and your products…
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 ink”, as snipped from PIC/S Version 13 Good Manufacturing Practices, §4.7 Good Documentation Practices 4.7…
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….
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