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…
With the increasing need to secure sensitive information, data integrity 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….
Data Trending and Alert/Action Levels definition are new requirements in the latest EU GMP Annex 1, Revision 12 draft. Trends allow you to quickly and easily identify changes in your cleanroom data and leverage this to make effective decisions, changes, and adjustments often before problems occur. Here we discuss three…