The role of data quality systems in pharmaceutical organizations has grown faster than any other function during the last 15 years. During this period, a small group dedicated to traditional Compliance grew and expanded to include Quality Experts in areas such as validation, product release, operations, sterility assurance, and other…
Question:Ā āWhat is the need of taking a non-viable particle count after a power outage for an hour. Our Class C area is stabilizing after 30 minutes of a power cut?ā There are several reasons for deploying your Non-Viable Environmental Monitoring Program following a power outage, but primarily it is to…
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….
