Validation Plan
Define scope, roles, deliverables, entry/exit criteria, environment requirements, and version control rules so the validation effort is auditable.
A clear validation document demonstrates that software performs as intended, reduces audit risk, and supports defensible release decisions. It consolidates evidence, defines acceptance criteria, and provides a single source of truth for cross-functional reviewers and regulators.
Teams that commonly prepare or review a Software Validation Document span quality, regulatory, IT, and business stakeholders.
Final sign-off typically requires a cross-functional approval to confirm completeness, traceability, and risk mitigation prior to production release.
Responsible for the overall validation program and final QA sign-off. Reviews test coverage, anomalies, corrective actions, and confirms that acceptance criteria are met before endorsing release.
Ensures the document satisfies regulatory and corporate policy requirements. Verifies traceability, retention, and audit evidence, then provides formal authorization for record retention.
Define scope, roles, deliverables, entry/exit criteria, environment requirements, and version control rules so the validation effort is auditable.
A traceability matrix linking system requirements to test cases, expected results, and pass/fail status to demonstrate full coverage.
Detailed test steps, test data, acceptance criteria, and environmental setup instructions enabling reproducible execution and objective results.
Tabulated results, evidence links, defect logs, and disposition of failures, including root-cause analysis and corrective actions.
Document identified risks, severity, mitigations, and residual risk after controls are applied to support release decisions.
Formal sign-off section with dated signatures from accountable stakeholders confirming acceptance and release authorization.
| Field | Configuration |
|---|---|
| Validation Plan | Attach as PDF; require initials on each page |
| Test Protocols | Enable version control and evidence attachments |
| Traceability Matrix | Link cells to source documents and test artifacts |
| Approvals Routing | Route role-based; require sequential sign-off |
Ensure the chosen platform supports secure signing, audit trails, and the file formats you use.
Confirm platform encryption and retention capabilities to meet legal and internal policy requirements before selecting storage or signing workflows.
Allow adequate time per protocol to reproduce and investigate failures
Allocate 3–5 business days for cross-functional review
Set a firm date before planned deployment
Archive final document immediately after approvals
Confirm retention schedule before disposal starts
Plan acceptance clears testing to begin and defines acceptance criteria.
All test protocols are run and results are documented with evidence.
All critical deviations resolved and verified by QA sign-off.
Authorized stakeholders sign the final validation record for archive.
| Criteria | Software Validation Document | Verification Test Report |
|---|---|---|
| Purpose | demonstrate system fitness | show test execution details |
| Required by Regulator | often | sometimes |
| Includes Test Results | ||
| Signed by QA | usually |
| signNow | DocuSign | Adobe Sign | PandaDoc | HelloSign | |
|---|---|---|---|---|---|
| Starting Price | $8/user/mo | $15/user/mo | $14/user/mo | $19/user/mo | $15/user/mo |
| Free Trial | Yes, 7-day trial | Varies | Varies | Varies | Varies |
| Bulk Send | Yes | Yes | Yes | Yes | Yes |
| Audit Trail | Yes | Yes | Yes | Yes | Yes |
| HIPAA Compliant | Yes | Yes | Yes | No | No |
| Envelope Cap | No envelope cap | 100 envelopes/user/year | Varies | Varies | Varies |