With the increasing need to secure sensitive information,Ā data integrityĀ is here to stay. What questions do you have about 21 CFR Part 11? Read on to find the answers to commonly asked questions on this topic. What is the trend in data integrity? The trend is towards assuring the data security….
Welcome to ourĀ 21 CFR Part 11 questions and answers blog, where Particle Measuring Systems answers commonly asked questions about bringing your quality system into the 21st century. For āoriginalā versions, we have a hybrid system where we print reports (and audit trails) from computer systems. Is the paper version considered…
The 2020 release of the EU GMP Annex 1 includes a new chapter on viable and non-viable environmental and process monitoring. Trend analysis and its impact on the contamination control strategy is now an essential activity that is referenced multiple times. We discuss the changes here.
