# Validation Summary Worksheet

Version 2.0 · Updated 2026-09-21 · Release

Summarise completed testing, unresolved deviations, residual risks, and the conclusion supporting release.

Adapt this template to your intended use, applicable requirements, and approved procedures.

## When to use it

Use before documenting the corresponding assessment or decision.

## Information needed before starting

- Approved intended use and functional-risk assessment
- Available supplier and local evidence
- Test environment, representative data and competent reviewers

## Field instructions

- **Proposed use:** Define the precise use proposed for release, including users, functions, environment and excluded actions.
- **Evaluated configuration:** Identify the exact version and local settings covered by the evidence; explain differences from the proposed release configuration.
- **Acceptance basis:** Reference approved requirements, risks and predefined acceptance criteria. Identify any changes and their justification.
- **Evidence reviewed:** List the executed tests, supplier evidence and other reviewed records, including identifiers, versions and material limitations.
- **Unresolved issue:** Identify each remaining deviation or evidence gap, its impact, owner and proposed restriction or follow-up.
- **Impact rationale:** Explain why the remaining issue does or does not affect the proposed use, referencing controls and supporting evidence.
- **Decision:** Record the supported use or restriction, the evidence and unresolved issues behind it, and the accountable decision owner.
- **Follow-up:** Assign each unresolved finding or additional check to an owner and due date; state the completion evidence required.
- **Monitoring:** State what will be compared or monitored, against which baseline, by whom and how often. Define discrepancy thresholds and the response.
- **Reassessment:** Define changes, incidents, performance signals or dates that require review of the release conclusion.

Could the conclusion still be defended if the reviewer only had the linked evidence and this record? An approval signature cannot replace a missing technical basis.

## Completed fictional example

Fictional teaching example; replace its values with your own assessed facts and evidence.

| Field | Completed example |
| --- | --- |
| Proposed use | eQMS CAPA workflow with defined routing |
| Evaluated configuration | Release 8.4, route configuration RC-12 |
| Acceptance basis | Approved requirements, assessed failures, defined evidence plan |
| Evidence reviewed | Supplier package, local tests, defect resolution, access checks, operating readiness |
| Unresolved issue | Dashboard spacing issue; no lost information or altered meaning in assessed views |
| Impact rationale | Does not affect routing, approval, or required record content within the assessed scope |
| Decision | Authorized use within the defined scope, subject to the organization’s approval process |
| Follow-up | Named owner and correction date in controlled issue record |
| Monitoring | Routing exceptions and export issues |
| Reassessment | Supplier, configuration, process, or permission changes affecting the claims |

## Blank template

System / record ID: ____________________

Prepared by / date: ____________________

Required review / approval under local procedure: ____________________

| Field | Your entry |
| --- | --- |
| Proposed use | ____________________ |
| Evaluated configuration | ____________________ |
| Acceptance basis | ____________________ |
| Evidence reviewed | ____________________ |
| Unresolved issue | ____________________ |
| Impact rationale | ____________________ |
| Decision | ____________________ |
| Follow-up | ____________________ |
| Monitoring | ____________________ |
| Reassessment | ____________________ |

## Related guidance

- [Make the release decision](https://csvtocsa.com/learn/release)

- [Review a SaaS release decision](https://csvtocsa.com/case-studies/saas-eqms-weekly-releases)

Canonical page: https://csvtocsa.com/worksheets/release-decision