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 …
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. …
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 …
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 …
“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 …
