21 CFR Part 11's Electronic Signatures

edited February 2020 in Functionality

... 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


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