Validation plan
Scope, system description, GAMP category, roles, deliverables and acceptance criteria agreed up front.
Regulated software · CSV / CSA
Validation for any GxP system, ours or a vendor’s.
Validation for systems you already run or are about to buy — commercial LIMS, QMS, ERP modules, chromatography data systems and GxP spreadsheets.
- ScopeAny GxP system
- ApproachGAMP 5 · CSA
- LifecycleURS → VSR → review
- ApprovalYour QA team
Bright Infonet is a Panchkula-based software company that provides computer system validation as a service for any GxP system, including third-party software. We plan and write the deliverables from URS to validation summary report, apply CSA-style risk-based testing, assess suppliers and run periodic reviews. Your QA approves every document and the validated state.
Most systems that need validation were not built by the team validating them. A lab buys a commercial LIMS, a plant extends its ERP, quality adopts a new QMS tool, or an analyst builds a spreadsheet that now feeds batch release. Each one is a computerised system under GxP and needs evidence that it is fit for its intended use.
We run validation as a project of its own. We start with a validation plan and an inventory of what the system does, classify it under GAMP 5, assess risk per function, and then focus testing where patient safety, product quality and data integrity are at stake. Low-risk functions get lighter, unscripted assurance, in line with FDA’s Computer Software Assurance thinking.
Because we also build regulated software, our testers understand how audit trails, signatures and interfaces are implemented, and where they tend to break. After go-live, we can support change control and periodic reviews so the system stays in a validated state rather than drifting out of it.
Deliverables
The validation file, end to end.
URS
User requirements written with process owners, each one specific, testable and traceable.
Supplier assessment
Questionnaire or audit of the software vendor, so you can rely on their testing where it is justified.
Risk assessment
Function-level risk scoring that decides where scripted testing is needed and where lighter assurance is enough.
IQ / OQ / PQ
Installation, operational and performance qualification protocols, executed with evidence and deviations recorded.
Trace matrix & VSR
Requirements traced to tests, and a validation summary report drafted for your QA to approve.
Validation services
Where validation usually stalls.
New system validation
Validation of a commercial or custom system before go-live, planned alongside the implementation timeline.
Legacy remediation
Gap assessment of a system already in use, then the documents and tests needed to close the gaps.
GxP spreadsheet validation
Locked templates, verified formulas and controlled versions for spreadsheets used in GxP decisions.
Audit trail review
A defined process and checks for reviewing audit trails as part of routine data review.
Change control support
Impact assessments and regression testing for upgrades, patches and configuration changes.
Periodic review
Scheduled reviews of incidents, changes, access and backups that confirm the system is still in control.
Is this for you?
A good fit if…
- You bought a GxP system and the vendor’s validation package does not cover your intended use.
- An audit observation flagged a system as not validated or not reviewed periodically.
- Your QA team is stretched and needs experienced help writing and executing validation documents.
- You want to move from heavy scripted testing towards a risk-based CSA approach.
FAQ
Common questions.
What is computer system validation?
Computer system validation (CSV) is documented evidence that a computerised system used in GxP work does what it is intended to do, consistently, and keeps data trustworthy. It covers planning, requirements, risk, testing, reporting and ongoing control.
What is the difference between CSV and CSA?
CSA (computer software assurance) is FDA’s risk-based way of thinking about the same goal. It puts more effort into high-risk functions and accepts lighter, unscripted testing for low-risk ones, instead of scripting everything.
Can you validate software you did not build?
Yes. Most of our validation work is for third-party systems. We assess the supplier, use their documentation where justified, and test your configuration and intended use.
Which documents do you deliver?
Typically a validation plan, URS, supplier assessment, risk assessment, configuration or functional specification, IQ/OQ/PQ protocols with executed evidence, traceability matrix and a draft validation summary report.
Who approves the validation?
Your Quality Assurance team. We prepare documents and support execution, but approval of protocols, results and the validated state stays with the regulated company.
How often should a validated system be reviewed?
At a frequency set by its risk, often yearly for critical systems. A periodic review checks changes, incidents, access, backups and audit trails since the last review.
Keep reading
Related pages.
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