This is a ready-to-use register for tracking every system and process a Validation Master Plan governs, so the VMP’s stated scope can be checked against reality at any time rather than reconstructed from memory. Replace every <<FILL: ...>> placeholder with your own specifics and keep the register current as systems are added, retired, or changed. A filled sample follows.
Purpose
This register records, for every system and process within the parent VMP’s scope, its GxP-impact category, its risk tier, its current qualification or validation status, and the dates of its last and next scheduled review, so the VMP’s scope statement can be verified against an actual, current inventory at any time.
Scope
Applies to every system, process, utility, and computerized system in scope under <<FILL: parent VMP document number>>, including items excluded from formal validation scope, which are recorded here with their exclusion rationale rather than omitted.
Field table
| Field | Format | Required | Who records it | When |
|---|---|---|---|---|
| System / process name | Text | Yes | Validation lead | On addition |
| Description | Text | Yes | Validation lead | On addition |
| GxP-impact test result | Pass, direct / Pass, indirect / Fail | Yes | Validation lead, per parent VMP methodology | On addition, re-scored on material change |
| Risk tier | 1 / 2 / 3, cross-referenced to the Validation Risk Classification Matrix | Yes | Validation lead | On addition |
| Qualification / validation status | <<FILL: e.g. Qualified, In progress, Not started>> | Yes | System owner | Ongoing |
| Date of last qualification/validation activity | Date | Yes | System owner | On completion of activity |
| Next periodic review due | Date, per the risk tier’s assigned interval | Yes | System owner | Ongoing |
| Owner (function) | Text, function not individual name | Yes | Validation lead | On addition |
| Exclusion rationale, if Tier 3 | Text | Yes, if Tier 3 | Validation lead | On addition |
Instructions
Add a row for every system or process at the time it enters GxP-relevant use, not retroactively at the next VMP review. Score the GxP-impact test and risk tier using the parent VMP’s methodology, cross-referencing the Validation Risk Classification Matrix rather than re-deriving the scoring logic here. Update the status and dates as qualification activity actually happens; a register showing a status that has not been touched since the system was added is itself a signal the register has gone stale. Retire a row, marking it clearly as retired with a date rather than deleting it, when a system is decommissioned.
Retention
Retain this register as a controlled, living document alongside the parent VMP, per <<FILL: site document retention procedure>>. Keep prior versions or a change history so “current version” is never ambiguous.
Filled sample rows
| System / process | Description | GxP-impact result | Tier | Status | Last activity | Next review | Owner |
|---|---|---|---|---|---|---|---|
| Chromatography data system | Generates and stores release-testing results for drug substance purity | Pass, direct | 1 | Qualified | <<FILL: date>> | <<FILL: 12 months from last activity>> | Computerized Systems |
| Shared team calendar / meeting scheduler | Internal tool used to schedule cross-functional meetings | Fail | 3 | Not applicable | Not applicable | Not applicable | N/A. Excluded: tool holds no product, process, or quality data of any kind |
Common findings this register prevents
- A VMP scope statement that does not match the current system inventory when the two are compared line by line, because no register was kept current between VMP reviews.
- A Tier 3 exclusion with no rationale recorded anywhere, indistinguishable from an oversight when reviewed later.
- A periodic review interval assigned in policy but not tracked against an actual due date for any specific system.
How to adapt this register
- Populate it from your actual current system and process inventory, not a list copied from another program or a prior employer’s template.
- Keep it updated in real time as systems are added, retired, or re-scored, not rebuilt from scratch at each VMP periodic review.
- Use it as the primary input to both the VMP Periodic Review Checklist and any VMP Gap Assessment Report; do not maintain two separate, potentially inconsistent inventories.