21 CFR Part 11's Electronic Signatures

bikahealth

... is back for discussion, Bika Health post, things might have changed since.

Please have a look at the Use Case in our current understanding, and comment. Which of the configuration objects have to be guarded, see shortlist in doc:

     1. Users
     2. Groups
     3. Analysis Services
     4. Methods
     5. Instruments
     6. Calculations
     7. Specifications
     8. Reference Definitions
     9. Reference Samples
     10. Clients?
     11. Suppliers?
     12. Sample Points?

Bests, Lemoene

lemoene

Updated in new doc
Edited with more detail and
NB, users also have to sign when data are created, e.g. registering Samples, or creating new setup objects