| Field | Value |
|---|---|
| Document ID | QC-DI-002 |
| Title | Record Completeness & Traceability |
| Document Type | Authoritative QC Specification |
| Owner | Quality Unit (QU) |
| Approver | Quality Unit (QU) |
| Effective Date | TBD |
| Version | v1.2 |
| Change Control Reference | TBD |
Establish enforceable, objectively verifiable requirements ensuring all GMP records supporting quality decisions are complete, attributable, contemporaneous, legible, accurate, and traceable in compliance with 21 CFR Part 111.
This specification mitigates risk of undocumented activity, data falsification, traceability gaps, unsupported release decisions, and regulatory noncompliance.
Applies To: All GMP records supporting material status, batch production, laboratory testing, deviation management, CAPA, change control, and release.
Includes: Paper and electronic systems.
Compliant Record: Meets all acceptance criteria.
Nonconforming Record: Minor deficiency not impacting data integrity.
Invalid Record: Missing critical data, unverifiable attribution, or broken traceability.
Critical Data: Data required to support material status or release decision.
Escalation Trigger: Any record deficiency requiring mandatory entry into Deviation or CAPA workflow based on impact or recurrence.
Stop-Execution Condition: Execution must stop when traceability reconstruction is not possible or when missing critical data prevents support of material or batch history.
| Attribute | Compliant State | Nonconforming State | Invalid State | Escalation Trigger | Required QMS Process Entry | QU Authorization Required? |
|---|---|---|---|---|---|---|
| Attribution | Performer identified by signature or secure electronic ID with date | Minor attribution deficiency not affecting data integrity or decision support | Missing performer ID or unverifiable attribution | Missing performer identification | Deviation | If release impacted |
| Contemporaneity | Entry made at time of activity; no retrospective entry without documented justification | Minor delay documented without impact to data integrity | Post-event reconstruction without acceptable justification | Post-event reconstruction | Deviation | If disposition impacted |
| Completeness | All mandatory fields populated | Minor omission not affecting critical data or decision support | Missing critical data or blank mandatory fields affecting record integrity | Missing critical data | Deviation | Yes |
| Traceability | Lot linkage intact and reconstruction possible | Minor traceability issue correctable without loss of record linkage | Traceability gap or inability to reconstruct material or batch history | Traceability gap | Deviation + CAPA (if systemic) | Yes |
Failure of any critical attribute places the record in an Invalid State. Failure of noncritical attributes places the record in a Nonconforming State.
| Trigger Condition | Execution May Continue? | Required Action | QMS Process Entry | Workflow (W)? | QU Authorization (A)? | Required Record |
|---|---|---|---|---|---|---|
| All criteria met | Yes | Accept record | None | No | No | Approved GMP Record |
| Minor noncritical omission | Yes, if record remains traceable and decision support is not impaired | Correct entry | Deviation (if required) | Yes (if deviation required) | No | Corrected Record |
| Missing critical data | No | Invalidate record | Deviation | Yes | Yes (if release impacted) | Deviation Record |
| Recurring record failures | No | System evaluation | CAPA | Yes | Yes | CAPA Record |
QC-DI-002 defines entry criteria only. Investigation and resolution mechanics are governed by the QMS Deviation and CAPA procedures.
Invalid records require Deviation entry.
Systemic failures require CAPA entry.
Disposition decisions based on reconstructed data require QU authorization.
Execution must stop if traceability reconstruction is not possible.
Compliant State: All criteria satisfied.
Nonconforming State: Minor deficiency without data integrity impact.
Invalid State: Critical data missing or traceability compromised.
Escalation Trigger: Any invalid record affecting release decision.
Stop-Execution Condition: Inability to reconstruct material or batch history.
Changes require formal Change Control entry, impact assessment, and QU approval.
Independent Quality Unit approval is required prior to implementation.
No implementation is permitted without documented QU authorization.