To ensure the reliability of data in the laboratory, it is necessary to collect knowledge about the principles of ALCOA+, data management, and practical techniques.
The lack of data reliability is the main reason for FDA warning letters.
In 2017, 65% of all warning letters mentioned data reliability issues. The main reason is that the data is unreliable, which can be prevented through appropriate solutions. The greater risk of not working in a compliant manner lies in the prohibition of imports, product recalls, and even the closure of production factories.
For laboratories that must comply with GLP, GMP, and GAMP regulations, it is important to have records or written evidence of all relevant analyses that can be inspected by a second party and used for auditing. Simply storing results is not enough, each result set must be complete and contain all relevant metadata.
Reliability of data in compliance with 21 CFR Part 11 and EU Appendix 11
The US FDA and the European Commission have developed standards to ensure reliable and trustworthy electronic records and electronic signatures in computerized systems regulating the pharmaceutical industry. Some pharmaceutical companies recently require instruments that are not connected to a computer to obtain 21 CFR Part 11 certification for the use of instrument firmware. But according to experts, independent instruments do not comply with the compliance and concepts of 21 CFR Part 11, and if used as a feasible solution, may lead to data loss or worse.
Use general software for data management
General software can play a critical role in lean automation data reliability solutions. General software such as Mettler Toledo's labx or stare only needs to be validated once, and each new analytical instrument only needs to be modified through change control because the software, data management, audit trail, user management, result flow, etc. have already been validated.