This is a ready-to-use change request form for a single process historian tag or a small batch of related tags. A tag add, delete, rename, or a change to its compression deadband, scan rate, retention period, or audit trail scope alters what the historian captures or keeps, which makes it a GxP-relevant configuration change, not a routine engineering edit. This form routes that change through a data integrity impact assessment before it reaches production and feeds the outcome back into the tag register. Replace every <<FILL: ...>> placeholder with your own specifics. A filled specimen follows. This is general guidance to adapt and verify against your own procedures, not legal or regulatory advice; confirm each cited regulation against the current source before you rely on it.
Header
| Field | Entry |
|---|---|
| Form title | Historian Tag / Point Configuration Change Request |
| Form number | <<FILL: FORM-ID, e.g. FRM-AUT-031>> |
| Version | <<FILL: version>> |
| Parent SOP | <<FILL: process historian governance SOP ID>> |
| Change control reference | <<FILL: CC number, assigned on approval>> |
| Retention | <<FILL: aligned to the tag's own retention period, minimum>> |
Field definitions
| Field | Format | Required | Who | When |
|---|---|---|---|---|
| Historian / system | Text | Yes | Requester | At request |
| Tag name(s) affected | Text, one row per tag if more than one | Yes | Requester | At request |
| Current GxP classification | GxP-critical / GxP-supporting / non-GxP | Yes | Requester (from register) | At request |
| Change type | Add / delete / rename / compression / scan rate / retention / audit trail scope / security / other | Yes | Requester | At request |
| Current setting | Text or value | Yes, except for “add” | Requester | At request |
| Proposed setting | Text or value | Yes | Requester | At request |
| Reason for change | Text | Yes | Requester | At request |
| DI impact assessment | See section below | Yes | Process SME | Before approval |
| Approvals | Signature block | Yes | Automation / QA | Before implementation |
| Implementation record | Who, when, evidence | Yes | Automation | At implementation |
| Register updated | Yes/No | Yes | Requester | After implementation |
1. Change request
| Field | Entry |
|---|---|
| Historian / system | <<FILL>> |
| Tag name(s) affected | <<FILL>> |
| Current GxP classification | <<FILL>> |
| Change type | <<FILL>> |
| Current setting | <<FILL>> |
| Proposed setting | <<FILL>> |
| Reason for change | <<FILL>> |
| Requested by (name, date) | <<FILL>> |
2. Data integrity impact assessment
Answer every question that applies to the change type. Any “yes” that is not resolved before implementation stops the change.
| Question | Applies to | Answer | If yes, resolution required |
|---|---|---|---|
| Does this change affect whether a future excursion could be smoothed out of the record (a wider deadband, a slower scan rate)? | Compression, scan rate | <<FILL: Y/N>> | Show the arithmetic against the parameter’s control or alarm limits before approval. |
| Does this change reduce what gets captured for a GxP-critical tag? | Compression, scan rate, audit trail scope | <<FILL: Y/N>> | Requires QA sign-off and a documented rationale, not just automation sign-off. |
| Does this change shorten retention below the requirement in the tag register? | Retention | <<FILL: Y/N>> | Not permitted without a documented, QA-approved basis tied to the applicable predicate rule and marketing authorization. |
| Does this change affect data already in flight (an open batch, an ongoing CPV window)? | Any | <<FILL: Y/N>> | State how in-progress data is protected; do not implement mid-batch on a GxP-critical tag without a documented justification. |
| Does this change require retroactive review of already-stored data (for example, a rename that breaks tag mapping in existing reports)? | Rename, delete | <<FILL: Y/N>> | Identify affected reports and reconcile before closing the change. |
| Does the tag register need to be updated as a result? | All | <<FILL: Y/N, almost always yes>> | Update the register and reference this change control number in it. |
3. Approvals
| Role | Name | Signature | Date |
|---|---|---|---|
| Requester | <<FILL>> | ||
| Process / area SME (DI impact assessment) | <<FILL>> | ||
| Automation / system owner | <<FILL>> | ||
| Quality Assurance | <<FILL>> |
4. Implementation and verification
| Field | Entry |
|---|---|
| Implemented by (name, date) | <<FILL>> |
| Audit trail entry reference | <<FILL>> |
| Post-implementation check (setting confirmed as configured) | <<FILL: Y/N, evidence>> |
| Tag register updated (Y/N, date) | <<FILL>> |
| Change control closed by (name, date) | <<FILL>> |
Acceptance criteria
- Every question in the DI impact assessment that applies to the change type is answered before approval, not after implementation.
- A change that could hide a GxP-critical excursion carries a numeric justification, not just a stated intent.
- Retention is never shortened below the tag register’s requirement without a QA-approved, documented basis.
- The tag register is updated and cross-references this form’s change control number before the change is considered closed.
- Implementation is captured in the historian’s own audit trail, attributable to a named individual.
Revision history
| Version | Date | Author | Summary of change |
|---|---|---|---|
<<FILL: 1.0>> | <<FILL: date>> | <<FILL: author>> | Initial issue. |
Filled specimen
An example request to widen a compression deadband on a GxP-supporting tag, illustrative values only.
| Field | Entry |
|---|---|
| Historian / system | Site historian, bioreactor suite |
| Tag name(s) affected | BR101.AGIT.SP |
| Current GxP classification | GxP-supporting |
| Change type | Compression |
| Current setting | None (store all) |
| Proposed setting | 2 rpm deadband |
| Reason for change | Reduce storage volume on a setpoint tag that changes in discrete steps, not continuously |
| Requested by | J. Marsh, automation engineer, 03 September 2026 |
| Question | Answer | Resolution |
|---|---|---|
| Could a future excursion be smoothed out of the record? | Y | Agitation setpoint moves in fixed 5 rpm steps set by the recipe; a 2 rpm deadband cannot mask a real setpoint change, only sensor noise between steps. Arithmetic recorded in the tag register. |
| Reduces capture on a GxP-critical tag? | N | Tag is GxP-supporting, not GxP-critical; no compression change proposed for the paired GxP-critical BR101.TEMP.PV. |
| Shortens retention? | N | Retention unchanged at 10 years. |
| Affects data in flight? | N | No batch currently running on BR101 at implementation time. |
| Requires retroactive review? | N | No rename or deletion involved. |
| Register update needed? | Y | Register row updated same day, referencing CC-2026-0410. |
Approved by process SME (M. Osei), automation (J. Marsh), and QA (R. Gomez), implemented 05 September 2026, verified against the configuration screen, and the register updated the same day.
Common inspection findings this form prevents
- A compression or scan-rate change implemented directly by an engineer with no documented data integrity impact assessment.
- A retention period shortened informally, with no record of who approved it or why.
- A tag rename that breaks report tag-mapping, discovered only when a reviewer asks why a trend is empty.
- The tag register left out of date after a configuration change, so the register no longer reflects the live system.
- A change applied mid-batch on a GxP-critical tag with no documented justification for the timing.
How to adapt this form
- Set your form number and point the parent SOP reference to your actual historian governance procedure.
- If your historian change volume is high, consider a lighter-weight version of section 2 for non-GxP tags and reserve the full impact assessment for GxP-critical and GxP-supporting tags.
- Link the change control reference generated here into your electronic change control system rather than tracking it only on paper.
- Make “register updated” a closure gate: the change control record does not close until the register row is confirmed current.