Lack of data integrity is a key reason for breaching compliance.
Shweta Nair, Sr. Product Manager - Biotechnology, at Advanced Instruments, sat down with Angela Bazigos, CEO of Touchstone Technologies Silicon Valley and a co-author of 21 CFR part 11 FDA guidelines.
From this resource, you will come away with the following:
- How becoming FDA 21 CFR part 11 compliant can benefit your lab organization
- How organizations can acheive data integrity
- Differences between 21 CFR part 11 and EU Annex 11
- Data integrity maintenance with closed, open or hybrid systems