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Computer system validation, connected from URS to summary report, in Matrix Validate

Validate eQMS, LIMS, ERP and in-house GxP applications with requirements, risk and testing linked in one system, following the GAMP 5 V-model your auditors expect.

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Matrix Validate test execution dashboard on a laptop

The challenge

Why CSV takes longer than it should

  • Test execution on paper or PDFScripts are printed or filled in a PDF tool, and evidence is pasted in afterwards. Proving the record was made at the time of testing is hard.
  • Trace matrices rebuilt by handURS, functional specs, risk assessments and test scripts sit in separate files, so the trace matrix is rebuilt every time something changes.
  • Vendor releases never stopEvery SaaS release and patch needs an impact assessment and regression testing, often across several systems at once.
  • Templates drift between systemsEach system gets its own copy of the protocol template, and over time no two validations look the same.
  • More systems every yearTeams now build internal tools with low-code and AI, and every one that touches GxP data has to be validated.
  • Inspections expect it on requestAuditors ask for signed protocols, executed scripts with evidence and a complete trace matrix, and they expect them quickly.

The solution

The V-model as connected data

Matrix Validate keeps every requirement, risk, test and result as its own item, so traceability is built as you work rather than assembled at the end.

  • URS, FS and DS as itemsEach requirement has its own ID, fields, version history and approval, and can be reused across systems.
  • Risk-based test scopeAssess each requirement in line with GAMP 5 and ICH Q9(R1), then scale the testing to the risk, as FDA's CSA guidance encourages.
  • Scripts traced to what they testEvery test script links to the requirements and risk controls it verifies. Trace rules flag anything left untested.
  • Execution with evidenceRecord pass or fail per step with comments, screenshots and attachments, and link failed steps to an issue or CAPA.
  • Change impact in one clickWhen a requirement or vendor version changes, every linked item downstream is flagged for review.
  • Signed deliverablesGenerate the validation plan, trace matrix and validation summary report from live data and sign them with Part 11 compliant e-signatures.

From URS to validation summary report

One project per system, or several systems in one project, organised the way your SOPs already describe.

01

Plan

Start from your own validation template. Record the system, vendor, version and GAMP 5 category, and set who reviews and approves.

02

Specify

Write or import user, functional and design requirements as items. Lock them for review and approve them with an e-signature.

03

Assess risk

Score each requirement or function for patient safety, product quality and data integrity impact, and decide the depth of testing.

04

Write test scripts

Author scripts with steps and expected results, or let the built-in AI draft them from your requirements for a person to review.

05

Execute

Run scripts step by step. Capture results, evidence and comments as you test, and raise deviations against the exact step.

06

Report and sign

Produce the trace matrix and validation summary report, sign them, and export them as PDFs to your QMS or document system.

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FAQ

01What is computer system validation (CSV)?

Computer system validation is the documented evidence that a computerised system used in GxP work does what it is intended to do, reliably and consistently. It follows a lifecycle: user requirements, specifications, risk assessment, testing and a summary report, then periodic review and change control for as long as the system is in use.

02What is the difference between CSV and CSA?

Computer Software Assurance (CSA) is a risk-based way of doing validation. FDA finalised its Computer Software Assurance guidance for production and quality system software in September 2025. It asks teams to focus testing effort on features with the highest risk and to cut documentation that adds no value. Matrix Validate supports both: you record the risk of each requirement and scale the testing to match.

03Which GxP systems can I validate with Matrix Validate?

Any configured or custom computerised system, typically GAMP 5 categories 4 and 5: eQMS, LIMS, ERP, document management, lab software, cloud and SaaS applications, and tools built in-house.

04Can we import the test scripts we already have?

Yes. Existing requirements and test scripts in Word or Excel can be imported and structured into items, so you do not have to start from a blank page.

05How does Matrix Validate handle vendor releases and periodic review?

Copy the validated project, apply the vendor's release notes, and the impact analysis shows which requirements and tests are affected. Rerun only the scripts that need it and redline the documents to show exactly what changed.

06Where can I see the whole product?

Read the Matrix Validate overview for every capability, or book a demo to see a CSV project for a system like yours.