21 CFR Part 11's Electronic Signatures
... 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?