Computer system validation Gantt chart template with IQ, OQ and PQ
An editable computer system validation Gantt chart: validation plan, requirements, risk, configuration, IQ/OQ/PQ scripts written alongside the build, deviations, traceability review, report and release.
What the computer system validation gantt chart template with IQ, OQ and PQ process is
Validating a computerised system is rarely slow because of the testing itself. It is slow because the scripts are written after the build, a failed step opens a deviation nobody has time for, and the traceability check at the end finds a requirement that no test covers. A timeline cannot fix that, but it shows where those waits sit before the project reaches them.
This template has four groups: Planning and risk, Specification and build, Test scripts and execution, and Reporting and release. It has 20 tasks and four milestones: "Validation plan approved", "Execution complete", "Validation report approved" and "Release system for use". "Write validation plan" (5 working days) and "Draft user requirements" (6) are the two starting tasks. "Assess risk to patients and data" (4) starts 2 days into the requirements, so the risk assessment sees the first draft instead of waiting for the finished one, and both feed "Validation plan approved".
The plan is a gate for the build, not for the scripts. "Write functional specification" (6) waits for "Validation plan approved". "Configure the system" (10) starts 3 days into the specification, and "Draft operating procedures" (5) starts 4 days into the configuration. The scripts are written while that work runs: "Write installation qualification script" (3) and "Write operational qualification script" (5) wait for the specification, and "Write performance qualification script" (5) waits only for the risk assessment, so it can be written against the requirements before the system is ready.
Execution is where the order matters. "Execute installation qualification" (3) needs both the configured system and its script. "Execute operational qualification" (8) follows it and its own script. "Resolve test deviations" (5) starts 3 days into the operational run, because failed steps surface early, and "Execute performance qualification" (8) waits for the deviations as well as its script. "Review requirements traceability" (3) starts after the operational run and finishes 1 day after performance execution, then "Write validation summary report" (4) and "Validation report approved" follow. "Release system for use" waits for that approval and for "Train users on approved procedures" (3). All durations are illustrative.
A timeline schedules the work. It does not make a system validated, compliant or approved, and it does not replace your validation procedure, your quality unit's decisions or the records you keep. For the neighbouring plans, see /templates/qms-implementation-gantt for the quality system around it, /templates/software-release-gantt for the release side of a software change, and /templates/change-control-process for how a change to a validated system is decided. For the planning method, see /guides/gantt-chart-dependencies. The same gate-and-sign-off logic runs through four neighbouring plans: /templates/clinical-trial-gantt-chart (a clinical study), /templates/medical-device-development-gantt-chart (device development), /templates/regulatory-submission-gantt-chart (a regulatory submission) and /templates/method-validation-gantt-chart (analytical method validation).
What this flowchart covers
In this template
- Four groups, Planning and risk, Specification and build, Test scripts and execution and Reporting and release, with 20 tasks and four milestones: "Validation plan approved", "Execution complete", "Validation report approved" and "Release system for use".
- Risk that starts early: "Assess risk to patients and data" starts 2 days after "Draft user requirements" starts, and "Validation plan approved" waits for both it and "Write validation plan".
- Scripts written beside the build: "Write installation qualification script", "Write operational qualification script" and "Write performance qualification script" run while "Configure the system" is in progress.
- A deviation loop inside the test window: "Resolve test deviations" starts 3 days after "Execute operational qualification" starts, and "Execute performance qualification" waits for it.
- A closing review with overlap: "Review requirements traceability" finishes 1 day after "Execute performance qualification" finishes, and "Release system for use" waits for "Validation report approved" and "Train users on approved procedures".
When to use this template
- You are validating a new or upgraded system and need to agree dates between the business owner, IT, quality and the supplier.
- You want to see how much of the schedule depends on writing scripts early, and what a long deviation does to the release date.
- A go-live date is fixed and you want to compare the finish date from the chart with the date you need.
- You want a repeatable skeleton for validation projects that each system team can adapt to its own procedure.
The plan, task by task
Every task in the chart with its length in working days and what it waits for. A dependency is a step number; SS is start-to-start, FF is finish-to-finish, and +n is a lag in working days.
| # | Task | Group | Working days | Depends on |
|---|---|---|---|---|
| 1 | Write validation plan | Planning and risk | 5 | |
| 2 | Draft user requirements | Planning and risk | 6 | |
| 3 | Assess risk to patients and data | Planning and risk | 4 | 2SS+2 |
| 4 | Validation plan approved | Planning and risk | Milestone | 1, 3 |
| 5 | Write functional specification | Specification and build | 6 | 4 |
| 6 | Configure the system | Specification and build | 10 | 5SS+3 |
| 7 | Draft operating procedures | Specification and build | 5 | 6SS+4 |
| 8 | Write installation qualification script | Test scripts and execution | 3 | 5 |
| 9 | Write operational qualification script | Test scripts and execution | 5 | 5 |
| 10 | Write performance qualification script | Test scripts and execution | 5 | 3 |
| 11 | Execute installation qualification | Test scripts and execution | 3 | 6, 8 |
| 12 | Execute operational qualification | Test scripts and execution | 8 | 9, 11 |
| 13 | Resolve test deviations | Test scripts and execution | 5 | 12SS+3 |
| 14 | Execute performance qualification | Test scripts and execution | 8 | 10, 13 |
| 15 | Execution complete | Test scripts and execution | Milestone | 14 |
| 16 | Review requirements traceability | Reporting and release | 3 | 12, 14FF+1 |
| 17 | Write validation summary report | Reporting and release | 4 | 15, 16 |
| 18 | Validation report approved | Reporting and release | Milestone | 17 |
| 19 | Train users on approved procedures | Reporting and release | 3 | 7, 15 |
| 20 | Release system for use | Reporting and release | Milestone | 18, 19 |
How it works
Start the plan and the requirements together
Keep "Write validation plan" and "Draft user requirements" as separate starting tasks, and replace the durations with how long your own approvers take.
Let risk start on a draft
"Assess risk to patients and data" is linked start-to-start with a lag of 2 days to the requirements. Change the lag if your assessors need more of the requirements first.
Gate the build on the plan
"Write functional specification" waits for "Validation plan approved". Move that link if your procedure lets design start earlier, and add your own tasks such as supplier assessment or data migration.
Write the scripts during the build
Keep the three script tasks beside "Configure the system" so they are ready when execution starts. If your scripts need a configured system to be written, link them to it instead.
Give deviations room
"Resolve test deviations" has 5 working days and starts during the operational run. Lengthen it if retests are likely, and watch how the finish date of "Execute performance qualification" moves.
Add owners, share and export
Put the responsible person in People, share the chart with IT, quality and the business owner, and export a PDF or CSV for the project file when you need a copy.
Frequently asked questions
How long does computer system validation take?
It depends on the system, its risk and your procedure. The template adds up to a plan of a few months of working days with illustrative lengths. Replace them with your own and read the finish date from the chart.
Does the chart validate the system or prove compliance?
No. It schedules the work. Validation is the evidence you produce and the decisions your quality unit makes. The chart shows when each part is meant to happen.
Why are the test scripts written in parallel with the build?
Because they depend on the specification and the requirements, not on the finished system. Writing them early takes them off the critical wait before execution. If your scripts need the configured system, change the links.
Can I use this for a cloud or supplier-hosted system?
Yes, with changes. Replace "Configure the system" with your own configuration and supplier-assessment tasks, and keep the plan, risk, execution and report gates.
How do I plan a revalidation after a change?
Copy the chart and shorten it to the tasks the change affects. For how the change itself is decided, see /templates/change-control-process, and for overlapping work in a plan, see /guides/gantt-chart-overlapping-tasks.