This is a ready-to-use register that inventories every electronic signature point in a computerized system workflow. It is the artifact that turns “the system has signatures” into a specified, testable set of signing requirements: what is signed at each point, the meaning, who is authorized, whether the signing is sequential within a continuous session (which drives the re-authentication logic), the method, and the binding and timeout controls that apply. Fill one row per signature point. It feeds the user requirements specification and the electronic signature OQ protocol. Replace every <<FILL: ...>> placeholder with your own specifics. A filled specimen follows. Verify each cited regulation against the current source before you rely on it.
Register control
| Field | Entry |
|---|---|
| Register title | Electronic Signature Point Register |
| Document number | <<FILL: FORM-ID, e.g. FRM-ESIG-004>> |
| Version | <<FILL: version>> |
| System name and ID | <<FILL: SYSTEM NAME / ID>> |
| Owner | <<FILL: system / process owner>> |
| Linked URS reference | <<FILL: requirement IDs>> |
| Linked OQ protocol | <<FILL: OQ-ESIG protocol ID>> |
Field definitions
| Field | Format | Required | Notes |
|---|---|---|---|
| Point ID | text, unique | Yes | A stable identifier for the signing point, for example ESP-01. |
| Workflow step | text | Yes | Where in the process the signing occurs. |
| Record / object signed | text | Yes | The exact record or object the signature binds to. |
| Meaning | controlled list | Yes | Authored, Reviewed, Approved, or a defined verb (11.50). |
| Authorized role(s) | list | Yes | The role(s) permitted to sign here; not named individuals. |
| In-session sequential? | Yes/No | Yes | Whether this signing can follow another in the same continuous session (drives 11.200(a)(1) re-authentication). |
| Method | text | Yes | Password two-component, biometric, or PKI/qualified. |
| Binding mechanism | text | Yes | Version link, content hash, or digital signature (11.70). |
| Timeout applied (min) | number | Yes | The inactivity timeout governing the session for this point. |
| Predicate rule / clause | text | Yes | The regulation the signing satisfies (for example batch release under 21 CFR 211.22). |
| Risk class | H/M/L | Yes | The consequence if this signature is repudiable or misapplied. |
Register
| Point ID | Workflow step | Record signed | Meaning | Authorized role(s) | In-session sequential? | Method | Binding | Timeout (min) | Predicate/clause | Risk |
|---|---|---|---|---|---|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
Instructions
- List every point in the workflow where a signature is applied, one row each. Do not omit administrative or acknowledgement signings.
- Set the meaning from the controlled list only; a meaning that reads “signature” with no verb is not acceptable.
- Name authorized roles, not individuals, so the register does not churn with personnel changes; the mapping of roles to people lives in the signing-account register.
- Mark “In-session sequential” Yes wherever a signer can reach this point directly after another signing without re-login, because those points must be tested for the subsequent-signing component logic.
- Assign a risk class from the consequence of a repudiable or misapplied signature at that point; batch release and QP certification are high.
- Trace each point to a requirement ID and to an OQ test case.
Retention
Retain the register for the life of the system plus the applicable records-retention period, and update it under change control whenever a signature point is added, removed, or re-scoped.
References
21 CFR Part 11, sections 11.50, 11.70, 11.200. EU GMP Annex 11 (Computerised Systems), electronic signatures, in-force 2011 version; the draft revision published 7 July 2025 renumbers electronic signatures to section 13. The predicate rule that requires the specific signing (for example 21 CFR 211.22 for quality-unit approvals, 211.194 for laboratory records).
Confirm the current version and clause numbers of each reference before issue.
Filled specimen
The following shows two rows completed for an example manufacturing execution system, so you can see the intended detail. The values are illustrative; replace them with your own.
| Point ID | Workflow step | Record signed | Meaning | Authorized role(s) | In-session sequential? | Method | Binding | Timeout (min) | Predicate/clause | Risk |
|---|---|---|---|---|---|---|---|---|---|---|
| ESP-04 | In-process weight verification | Batch record weighing step | Reviewed | Production reviewer | Yes | Password two-component | Version link + SHA-256 hash | 15 | 21 CFR 211.188 | Medium |
| ESP-09 | Batch disposition | Batch disposition record | Approved (QA release) | QA release authority | No | Password two-component | Version link + SHA-256 hash | 10 | 21 CFR 211.22 | High |
In this example ESP-09, the batch-release signing, is marked not in-session sequential and carries a shorter timeout and a high risk class, because a repudiable release signature is the most consequential failure on the system. ESP-04 is marked sequential because a reviewer signs several weighing steps in one session, so its subsequent-signing component logic must be tested. The register is what tells the OQ author exactly which re-authentication branches to exercise.
Common inspection findings this register prevents
- Signature points that were never inventoried, so some signings were never specified or tested.
- A meaning applied at a step that does not match the workflow (Approved where the procedure says Reviewed).
- Sequential in-session signings that were never tested for the correct subsequent-signing component.
- Timeout and method decisions made per system rather than per the risk of each signing point.
How to adapt this form
- Set the document number and system identity and link the register to the URS and OQ protocol.
- Add one row per real signature point in your workflow; expand the table as needed.
- Keep the meaning values aligned with the controlled list configured in the system.
- Use this register as the direct input to the OQ test-case selection, so every high-risk point has matching binding, manifestation, and re-authentication tests.
- Confirm every regulation in the references against the current published version before issue.