“A Partnership in Data Traceability: 21 CFR part 11, the CryoMed controlled-rate freezer, and Your Lab/Production Processes”
Data traceability and maintaining a clear chain of custody for information is an obstacle that most GMP Laboratories face upon start-up, particularly when it comes to maintaining the requirements of 21 CFR part 11. In order to meet the requirements of 21 CFR part 11, a “partnership” must be formed between the equipment in the laboratory and the internal GMP processes at your site. Please join us for an in-depth look at how the Thermo Scientific CryoMed controlled-rate freezer supports your path to maintaining 21 CFR part 11 requirements. We will explore how the CryoMed maintains data and records as well as discuss the clauses of 21 CFR part 11 that require a partnership between equipment and your internal processes.