This is a ready-to-use periodic report for the data criticality and risk classification program as a whole, distinct from the per-stream assessment form completed for one record stream at a time. It answers the question a quality management review actually asks: is the classification program covering everything it should, and is the picture getting better or worse. Replace every <<FILL: ...>> placeholder, attach the supporting per-stream assessments, and route it through your normal document control, review, and approval. A worked filled specimen follows. Verify each cited regulation against the current source before you rely on it.
Document control header
| Field | Entry |
|---|---|
| Document title | Data Criticality and Risk Classification Program Review |
| Document number | <<FILL: report ID, e.g. DCR-PROG-2026-02>> |
| Version | <<FILL: version, e.g. 1.0>> |
| Effective date | <<FILL: effective date>> |
| Document owner | <<FILL: role, e.g. Data Governance Lead>> |
| Review period | <<FILL: dates covered>> |
| Site(s) / scope | <<FILL>> |
1. Purpose
This report rolls up the data criticality and risk classification program across the record-stream inventory at <<FILL: site / scope>>, confirms coverage is complete, summarizes the priority-band distribution, tracks drift since the last review, and lists open gaps with owners and due dates. It feeds the quality management review and confirms the program is doing what it exists to do: making sure control effort lands where consequence and likelihood are highest.
2. Coverage completeness
| Field | Entry |
|---|---|
| Total GxP record streams in the data stream inventory | <<FILL>> |
| Streams with a current classification (within the review cycle) | <<FILL>> |
| Streams unclassified or overdue for re-classification | <<FILL: count and list, or "None">> |
| Coverage percentage | <<FILL>> |
An unclassified or overdue stream is a program gap in its own right, independent of what its classification would eventually show. List every one with a target date to close it.
3. Priority-band distribution
| Priority band | Number of streams | Percentage of total | Change since last review |
|---|---|---|---|
| Critical / High | <<FILL>> | <<FILL>> | <<FILL>> |
| Medium | <<FILL>> | <<FILL>> | <<FILL>> |
| Low | <<FILL>> | <<FILL>> | <<FILL>> |
A rising Critical/High count is not automatically a problem, new high-consequence systems come online, but it should be explainable. A Critical/High count that keeps climbing with no corresponding explanation is worth a closer look at whether the scoring has drifted looser or tighter over time, or whether classifications are being inflated to justify existing (or insufficient) control levels rather than the reverse.
4. Control-depth conformance
For a sample of streams in each priority band, confirm the actual control depth in place matches what the band requires.
| Priority band | Streams sampled | Streams meeting required control depth | Gaps found |
|---|---|---|---|
| Critical / High | <<FILL>> | <<FILL>> | <<FILL>> |
| Medium | <<FILL>> | <<FILL>> | <<FILL>> |
| Low | <<FILL>> | <<FILL>> | <<FILL>> |
This is the step that catches a classification that exists on paper but never actually changed what happens operationally, a High-priority stream classified correctly a year ago whose audit trail is still reviewed only monthly because nobody updated the review schedule to match.
5. Drift and re-classification triggers
| Field | Entry |
|---|---|
| Streams re-classified this period due to a system change | <<FILL>> |
| Streams re-classified this period due to a process change | <<FILL>> |
| Streams re-classified this period due to a deviation or inspection finding | <<FILL>> |
| Streams re-classified purely on the periodic cycle | <<FILL>> |
| Triggered re-classifications missed (a known change happened but classification was not revisited) | <<FILL: count and list, or "None">> |
A high count of missed triggered re-classifications signals the classification program is not wired into change control the way it should be.
6. Open gaps and corrective actions
| Gap | Priority | Owner | Due date | Status |
|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | Open / Closed |
7. Acceptance criteria for this review
- The data stream inventory is reconciled against an independent source (IT asset register, calibrated instrument list, or equivalent) and coverage is stated as a real percentage, not assumed complete.
- Every unclassified or overdue stream is listed with a target closure date.
- The priority-band distribution and its change since the last review are stated, with an explanation for any material shift.
- A sample of streams in each band was checked for actual, operating control-depth conformance, not just the classification decision on paper.
- Missed triggered re-classifications are identified and addressed, not silently absorbed into the next periodic cycle.
8. Conclusion
State, in one or two sentences, whether the classification program is providing complete, current, and operationally reflected coverage of the record-stream inventory, citing the coverage percentage and any material gap.
9. References
MHRA “GxP Data Integrity Definitions and Guidance for Industry” (March 2018). PIC/S PI 041-1, Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments. EU GMP Annex 11, paragraph 11 (periodic evaluation). ICH Q9(R1), Quality Risk Management.
Confirm current versions before issue.
10. Attachments
| No. | Attachment |
|---|---|
| 1 | Current data stream inventory |
| 2 | Per-stream classification assessments sampled for control-depth conformance |
| 3 | Corrective action records for open gaps |
11. Revision history
| Version | Date | Author | Summary of change |
|---|---|---|---|
<<FILL: 1.0>> | <<FILL: date>> | <<FILL: author>> | Initial issue. |
12. Approvals
| Role | Name | Signature | Date |
|---|---|---|---|
| Author (Data Governance Lead) | <<FILL>> | ||
| Reviewer (QA) | <<FILL>> | ||
| Approver (Quality Head) | <<FILL>> |
Filled specimen
The following shows an abbreviated rollup for an example annual program review. The company, counts, and gaps are illustrative; replace them with your own.
| Field | Entry |
|---|---|
| Review period | Calendar year 2026 |
| Coverage | 212 of 220 record streams currently classified (96 percent); 8 unclassified, all newly onboarded systems pending initial assessment, target closure 30 Sep 2026 |
| Priority-band distribution | Critical/High: 34 (16 percent, up from 29 last year, explained by 5 new AI-assisted inspection and analytics streams brought into scope); Medium: 98 (46 percent); Low: 80 (38 percent) |
| Control-depth conformance sample | Critical/High: 10 sampled, 9 conforming, 1 gap (audit trail reviewed monthly instead of per-run); Medium: 8 sampled, 8 conforming; Low: 5 sampled, 5 conforming |
| Missed triggered re-classifications | 1: a LIMS interface change in March 2026 was not accompanied by a re-classification review; caught during this program review, not at the time of the change |
| Open gaps | GAP-2026-04, audit trail review frequency mismatch on Critical/High stream, Major, owner QC Lab Manager, due 15 Oct 2026, Open. GAP-2026-05, change-control trigger for re-classification not consistently applied, Major, owner Data Governance Lead, due 30 Nov 2026, Open |
| Conclusion | The classification program provides 96 percent coverage with a clear plan to close the remainder. One control-depth gap and one process gap (missed triggered re-classification) were identified and opened as corrective actions; the rising Critical/High count is explained by genuine new AI-assisted systems, not scoring drift |
The value of this report is in the two things a per-stream assessment cannot show on its own: whether the program’s coverage is actually complete against an independent count, and whether a classification that looked right on paper is still driving the right control in practice a year later.
Common inspection findings this report prevents
- A classification program that looks complete because nobody checked it against an independent system count.
- A rising Critical/High count with no explanation, leaving an inspector to wonder whether scoring has drifted.
- Classifications that are correct on paper but never triggered the control-depth change they implied.
- A system change that should have triggered re-classification, discovered only at the next scheduled program review instead of at the time of the change.
How to adapt this report
- Set your document number, owner, and review period in the header.
- Reconcile your coverage count in section 2 against an independent source, not just the classification tracker itself.
- Set your control-depth conformance sample size in section 4 to be statistically meaningful for your portfolio size.
- Wire section 5’s trigger tracking into your change control and deviation systems so missed triggers surface here rather than nowhere.
- Confirm every regulation in section 9 against the current published version before issue.