This is a ready-to-use inventory that maps every distribution record type to the system that generates it, who owns it, what data-integrity controls exist today, and how critical it is to product quality and patient safety. It is the governance document that answers “where do we concentrate our review and 3PL oversight effort,” and it is the input to a risk-based audit trail review program. Replace every <<FILL: ...>> placeholder with your own specifics and keep it under change control. A worked specimen follows.
Document control header
| Field | Entry |
|---|---|
| Matrix title | Distribution Record Criticality and Ownership Map, <<FILL: SITE / NETWORK>> |
| Document number | <<FILL: MTX-ID>> |
| Version | <<FILL: version>> |
| Effective date | <<FILL: date>> |
| Owner | <<FILL: QA / distribution quality lead>> |
1. Purpose
Inventory every GDP-relevant distribution record type in <<FILL: SITE / NETWORK>>, its system of record, its owner, its current data-integrity controls, and its criticality, so review effort, 3PL audit scope, and remediation priority are set by risk rather than by convenience.
2. Criticality rating scale
| Rating | Definition |
|---|---|
| High | Directly supports a release, disposition, or recall-reach decision; an integrity failure could mean product of unknown or unacceptable condition reaches or is missed for a patient |
| Medium | Supports operational or investigative decisions but does not itself gate release or disposition |
| Low | Reference or administrative value; no direct quality or safety consequence if delayed or imperfect |
3. Record inventory matrix
One row per record type. Add rows as needed.
| Record type | System of record | Owner | Electronic / paper | Audit trail present? | Individual logins (no shared accounts)? | Retention defined? | Criticality | Notes / gaps |
|---|---|---|---|---|---|---|---|---|
<<FILL: e.g. transit temperature record>> | <<FILL: logger portal>> | <<FILL>> | <<FILL>> | <<FILL: Yes/No>> | <<FILL: Yes/No>> | <<FILL: Yes/No>> | <<FILL>> | <<FILL>> |
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
4. Third-party-held records
Records generated or held by a 3PL or other contract acceptor need an explicit access statement, since you own the responsibility even though you do not administer the system.
| Record type | Held by (3PL/vendor) | Your contractual access right confirmed? | Format of access (live query, periodic export, on-request) | Notes |
|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL: Yes/No>> | <<FILL>> | <<FILL>> |
5. Acceptance criteria
- Every distribution record type your network generates or relies on has a row; none are omitted because they seem minor.
- Every High-criticality record has a confirmed audit trail, individual logins, and a defined retention period; any “No” in these columns for a High row is a documented gap with an owner and a target date.
- Every third-party-held record has a confirmed contractual access right; an unconfirmed right on a High-criticality record is escalated, not left open indefinitely.
- The matrix is reviewed at a defined interval (
<<FILL: e.g. annually, or on any new system/3PL onboarding>>) and updated when a record type, system, or 3PL relationship changes.
6. References
EU GDP Guidelines (2013/C 343/01), Chapter 4 (Documentation) and Chapter 7 (Outsourced Activities). 21 CFR 211.142 and 211.150 (US warehousing and distribution procedures and records). MHRA GxP Data Integrity Guidance and Definitions; PIC/S PI 041-1. ICH Q9(R1), Quality Risk Management, for the criticality rating approach.
Confirm the current version and clause numbers of each reference before issue.
7. Revision history
| Version | Date | Author | Summary of change |
|---|---|---|---|
<<FILL: 1.0>> | <<FILL: date>> | <<FILL>> | Initial inventory. |
8. Approvals
| Role | Name | Signature | Date |
|---|---|---|---|
| Distribution quality lead | <<FILL>> | ||
| IT / validation | <<FILL>> | ||
| Supplier quality (for 3PL rows) | <<FILL>> |
Filled specimen
The following shows four illustrative rows. Values are illustrative.
| Record type | System of record | Owner | Format | Audit trail? | Individual logins? | Retention defined? | Criticality | Notes / gaps |
|---|---|---|---|---|---|---|---|---|
| Transit temperature record | Logger portal (vendor-hosted) | Cold-chain SME | Electronic | Yes | Yes | Yes, 1 year past expiry | High | None open |
| Dispatch / pick-pack record | WMS | Warehouse operations | Electronic | Yes | Yes | Yes | High | None open |
| Warehouse storage monitoring | BMS | Facilities | Electronic | Yes | No, shared facilities-team login on the BMS console | Yes | High | Gap: shared login on a High record; CAPA-2026-0091 open, target 2026-10-31 |
| 3PL dispatch record | 3PL’s WMS, not administered by us | Supplier quality | Electronic | Unconfirmed | Unconfirmed | Per quality agreement, confirm at next audit | High | Gap: access right stated in quality agreement but not yet tested; scheduled for the next 3PL audit |
The BMS row shows exactly the kind of finding this matrix is built to surface before an inspector does: a High-criticality record with a real control gap, now tracked to a CAPA with a target date instead of sitting undiscovered until an audit.
Common inspection findings this matrix prevents
- A distribution record type nobody had formally inventoried, discovered only when an inspector asks a question about it.
- A High-criticality record with a known control gap (shared login, no audit trail, undefined retention) that was never escalated because no single document forced the question.
- A 3PL-held record with an assumed but never-tested contractual access right.
- Review and audit effort spread evenly across all records instead of concentrated on the ones that actually gate a quality decision.
How to adapt this matrix
- Build the inventory from your actual distribution process map, not from a generic list; walk receiving through dispatch through returns and list every record each step generates.
- Rate criticality by consequence to the patient and to a recall, not by how much data volume a record produces.
- For every 3PL-held record, confirm the access right is not just written into the quality agreement but has actually been exercised and tested.
- Feed every “No” or “Unconfirmed” cell on a High-criticality row into your CAPA or gap-tracking system with an owner and a date; a matrix with open gaps and no tracking is not actually governing anything.