Data integrity refers to maintaining and assuring the accuracy and consistency of data over its entire life-cycle, and is a critical aspect to the design, implementation and usage of any system which stores, processes, or retrieves information. Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality.
The introduction to the FDA guidance reads:
FDA expects that data be reliable and accurate (see the “Background” section). CGMP regulations and guidance allow for flexible and risk-based strategies to prevent and detect data integrity issues. Firms should implement meaningful and effective strategies to manage their data integrity risks based upon their process understanding and knowledge management of technologies and business models."
The draft guidance can be accessed here.
Posted by Dr. Tim Sandle
No comments:
Post a Comment
Pharmaceutical Microbiology Resources