Validation Project Plan

This is a ready-to-use validation project plan for a single computerized system. It sits below the validation master plan and above the individual protocols: it names the system, fixes the GxP and risk decision, scopes the deliverables, assigns the roles, and sets the schedule and the rule for declaring the project done. Replace every <<FILL: ...>> placeholder with your own specifics, set your document numbers and dates, and route it through your normal document control, review, and approval. A worked filled specimen follows the template so you can see how a completed version reads. Verify each cited regulation against the current source before you rely on it.

Document control header

1. Purpose

This plan defines the approach, deliverables, roles, schedule, and acceptance criteria to validate <<FILL: SYSTEM NAME>> for its intended GxP use at <<FILL: site / scope>>. The objective is to establish, with documented evidence, that the system is fit for its intended use, that the records it holds meet ALCOA+ data integrity expectations, and that it is released into operational use in a controlled, traceable state. This plan governs the validation project only; ongoing operation, change control, and periodic review are governed by the procedures named in section 11.

2. Scope

2.1 In scope

This plan covers the validation of <<FILL: SYSTEM NAME>> version <<FILL: software version>>, including the application, its configuration, the supporting infrastructure qualification status it depends on, the interfaces listed in section 4, and the data migration listed in section 4 (where applicable). It covers the validation lifecycle from planning through the summary report and release into operational use.

2.2 Out of scope

This plan does not cover <<FILL: list out-of-scope items, e.g. non-GxP modules, future phases, third-party systems validated under their own plan>>. Infrastructure qualification (servers, network, virtualization, database platform) is assumed complete and is referenced, not re-performed here; see assumptions in section 9.

3. System description

State plainly what the system does and what records it owns. An inspector reads this section first to understand what is at stake; vague descriptions invite scope creep and challenge.

4. GxP determination and risk classification

4.1 GxP assessment

4.2 GAMP 5 software category and system risk

Classify the software per GAMP 5 (Second Edition) and set the overall validation rigor from category and process risk together. The category drives how much you specify and test; process risk drives how hard you challenge the high-impact functions.

A functional risk assessment (per section 5.3) refines this within the system: not every function carries the same risk, so test effort follows the high-risk functions. State here that the depth of each deliverable is set by this classification, so the plan reads as risk-based rather than one-size-fits-all.

5. Validation strategy

5.1 Lifecycle approach

State the lifecycle model you will follow (for example a specify-and-verify V-model, or a Computer Software Assurance critical-thinking approach that scales effort to risk). The FDA CSA guidance, current version issued 3 February 2026, supports using unscripted and ad hoc testing for lower-risk features and reserving scripted testing for high-risk features. Name which approach this project uses and why.

5.2 Reuse of supplier evidence

Where supplier testing, vendor IQ/OQ packs, or audited supplier quality records are reused to reduce duplicate effort, name the supplier assessment that justifies the reuse and state which deliverables consume that evidence. Reuse is acceptable when the supplier assessment supports it; it is not acceptable as an unexamined shortcut.

5.3 Functional risk assessment

A functional risk assessment is a deliverable of this project (section 6). It scores each GxP function by severity, probability, and detectability, sets the test depth per function, and feeds the traceability matrix. High-risk functions receive scripted, evidence-heavy testing; low-risk functions receive lighter verification.

6. Deliverables

The deliverables below are scaled to the classification in section 4. Mark any deliverable not applicable with a written justification rather than silently dropping it.

7. Roles and responsibilities

Name actual people or roles in your approved version. A reviewer expects the person who approves the work to be independent of the person who executes it.

8. Schedule

Show dependencies, not just dates. The most common schedule failure is starting IQ before the infrastructure it sits on is qualified.

9. Assumptions and constraints

List every assumption the plan depends on, because each one is a risk if it proves false.

• <<FILL: e.g. The hosting infrastructure is qualified under IQ reference ___ and remains under change control.>>
• <<FILL: e.g. The supplier assessment dated ___ supports reuse of vendor IQ/OQ evidence.>>
• <<FILL: e.g. The system clock is synchronized to a controlled time source and time zone is fixed.>>
• <<FILL: e.g. No GxP data is migrated; or, data migration is covered by plan ___ .>>
• <<FILL: e.g. SaaS provider change notification and audit-trail access are contractually assured.>>
• Constraint: <<FILL: e.g. fixed go-live date, frozen configuration baseline, resource availability>>.

If an assumption is later shown false, that triggers a deviation under section 12 and may require re-planning, not a quiet workaround.

10. Acceptance criteria for the project

The validation project is complete and the system may be released into operational use only when all of the following are true:

• Every applicable deliverable in section 6 is executed, reviewed, and approved, or is marked not applicable with a written justification.
• All requirements in the URS are traced forward to a specification and a test, and every test traces back to a requirement, with no orphan tests and no untested requirements.
• All planned test cases are executed; every test result is pass, or has a closed deviation with a documented, justified disposition.
• All deviations raised during the project are closed, with any that remain open at release formally assessed as not affecting fitness for intended use and accepted by QA.
• The Part 11 and data integrity assessment confirms audit trail, access control, and (where used) electronic signatures meet the applicable requirements, with any gaps remediated or risk-accepted in writing.
• Operational SOPs and training (use, administration, backup and restore, disaster recovery) are in place and approved before go-live.
• The validation summary report is approved by QA and states the validated configuration baseline and the release decision.

11. Operational handover and ongoing control

On release, the system passes to operational control. Name the procedures that take over so the plan does not leave a gap after go-live.

12. Deviation handling

Any departure from this plan, any test failure, and any assumption shown false is recorded and assessed before the project is declared complete.

1. Record the deviation against the affected protocol or deliverable, with the observed result, the expected result, and the immediate impact.
2. Assess impact on patient safety, product quality, and data integrity, and on the validated state of any function already tested.
3. Classify and route per <<FILL: deviation SOP-ID>>; minor deviations may be dispositioned within the test record, significant ones require investigation and CAPA.
4. Where a fix changes configuration or code, re-test the affected function and update the traceability matrix.
5. Do not release the system while any deviation that affects fitness for intended use is open. Document the disposition of every deviation in the summary report.

13. References

21 CFR Part 11 (electronic records and electronic signatures). 21 CFR 211.68 (automatic, mechanical, and electronic equipment). 21 CFR Part 820 (Quality Management System Regulation, QMSR, effective 2 February 2026, incorporating ISO 13485:2016 by reference) for device systems. EU GMP Annex 11 (Computerised Systems). EU GMP Annex 15 (Qualification and Validation), 2015 revision. FDA Guidance, Computer Software Assurance for Production and Quality Management System Software, issued 3 February 2026 (superseding the 24 September 2025 final). GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems, Second Edition (ISPE). ICH Q9 (Quality Risk Management). PIC/S PI 011 (Good Practices for Computerised Systems in Regulated GxP Environments). ISO 13485:2016, where the system supports a medical device.

Confirm the current version and clause numbers of each reference before issue.

14. Revision history

15. Approvals

Filled specimen

The following shows the classification, deliverables, and acceptance sections completed for an example configured laboratory system, so you can see the level of detail an inspector expects. The company, system, and numbers are illustrative; replace them with your own.

In this example the team set the rigor from a category 4, high-risk classification, reused vendor OQ only after a documented supplier assessment, applied scripted testing to the result-calculation and e-signature functions while keeping low-risk screens light, traced every requirement, and released against a named configuration baseline with one minor deviation formally risk-accepted. That sequence is exactly what a reviewer is expected to see.

Common inspection findings this plan prevents

• A system in GxP use with no validation plan, or a plan written and approved after testing was already done.
• One depth of validation applied to every system regardless of GAMP category or risk, with no rationale for the effort spent.
• Vendor IQ/OQ evidence reused with no supplier assessment to justify the reuse.
• Requirements that are never tested, or tests that trace to no requirement, found when the traceability matrix is requested.
• Test failures recorded as passes, or deviations left open at release with no impact assessment or QA acceptance.
• A validated system released with no audit trail review, backup/restore, or change control procedure in place, so it falls out of control the day after go-live.
• A SaaS or cloud system treated as validated without confirming audit-trail access, change notification, and the supplier’s quality status.
• No defined configuration baseline, so the validated state cannot be distinguished from later undocumented changes.

How to adapt this plan

1. Set your document number, owner, parent VMP, and summary report number in the header.
2. Complete the GxP determination and the GAMP 5 category and risk in section 4 honestly; the rest of the plan scales from that decision.
3. Mark each deliverable in section 6 applicable or not applicable, and justify every N/A in writing.
4. Replace the schedule in section 8 with real dates and show the true dependencies, especially infrastructure qualification before IQ.
5. List every assumption in section 9; each false assumption becomes a deviation, so name them up front.
6. Point the cross-references in sections 11 and 12 to your real change control, periodic review, backup, access, and deviation procedures.
7. Confirm every regulation in section 13 against the current published version before issue.