A review of the draft update to EU and PIC/S Annex 11 Computerised Systems Can you remember what mobile phone you had in 2011? Was it even a smart phone? And now can you imagine how your life would work without one? And yet in that time the Good Manufacturing Practice (GMP) annex that dictates…
Data integrity continues to be a focus during US FDA inspections. A number of warning letters issued by the FDA in 2022 highlight the importance of Data Integrity compliance. In the warning letters issued, the FDA references the FDA’s guidance on Data Integrity; “Your quality system does not adequately ensure the accuracy and integrity of…
Cannabis Seed to sale software and other computer software in general, can be a blessing to some, and a curse to others. Either way, the usefulness of paperless technology cannot be stated enough, especially in a Pharma 4.0 era. Many industries have experienced the “paper-fatigue” that arises from the requirement to generate piles and piles…
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 frequently hear, “How do you validate the cloud?” or “What will the regulator say?”, but most…
At the beginning of last year (2014), I posed the above question “Should Requirements Traceability Matrices (RTMs) be formally controlled documents?” on LinkedIn because I wanted to get thoughts from people working in the pharmaceutical industry regarding how they went about it. I thank all those that have taken the time to respond. In essence,…
“We have just concluded several regional training sessions with Sion Wyn on IT compliance and Computer System Validation for the drug, device and vet industries. The course curriculum was developed with industry representatives to incorporate current issues and perceived looming mega trends; providing a real world view for the next 2 years. While developing the…
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