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The Part 11 Toolkit provides MS Access databases with:
| • | Audit Trails - All changes to system data are recorded. Deleted records are retained. The Part 11 Toolkit audit trail meets all requirements for 21 CFR 11.10e. |
| • | Password Protection - All databases require a valid UserID and password to access. Password protection is an element of limited system access, required by 21 CFR 11.10d. |
| • | User-Level Security - Users can be designated with specific privileges to add, edit or delete system data. Groups of users can either be permitted or denied access to specific program functionality or work-flows. User-level security is an element of limited system access and authority checks, required by 21 CFR 11.10d and 21 CFR 11.10g. |
| • | Electronic Signatures - Electronic signatures can lock data records, preventing accidental or intentional changes to the data. The Part 11 Toolkit electronic signatures meet all requirements for 21 CFR 11, subpart B. |
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