User requirements (URS)
Clear, testable requirements for a real LIMS, written from the users’ point of view.
Academy · Software Validation · 8 weeks
Computer system validation and GAMP 5 training.
Eight weeks of live online training in computer system validation, taught by the team that builds and validates LIMS and pharmacovigilance software — and practised on a working system.
- Duration8 weeks
- FormatLive online
- LevelQA & life-science
- StackGAMP 5 · CSV · Part 11
Bright Infonet’s Software Validation course is an 8-week live online program for QA and life-science professionals in India. You learn GAMP 5, computer system validation, URS, risk assessment, traceability, IQ/OQ/PQ protocols and 21 CFR Part 11 data integrity, and produce a complete validation pack for a working LIMS.
Many people in pharma QA, QC and IT are asked to validate systems without ever seeing how the software is built. This track connects the two: it is taught by a team that develops regulated software, including a LIMS and a pharmacovigilance platform, and writes the validation documents that go with it.
You start with GxP principles and GAMP 5 categories and lifecycle, then write a URS, run a risk assessment and build a traceability matrix. After that you draft and execute IQ, OQ and PQ scripts, and close with 21 CFR Part 11, EU Annex 11 concepts, ALCOA+ data integrity and the validation summary report.
Classes are live online, so working professionals across India can attend. We also explain how the risk-based thinking in FDA’s Computer Software Assurance guidance fits alongside traditional CSV, so your approach matches what reviewers now expect.
8 weeks · Live online · QA & life-science
The syllabus.
Learn computer system validation the way pharma auditors expect it — on a live LIMS.
- Weeks 1–2
GxP & GAMP 5
Categories, lifecycle, roles
- Weeks 3–4
URS, risk & RTM
Requirements, FMEA, traceability
- Weeks 5–6
IQ / OQ / PQ
Protocols, scripts, execution
- Weeks 7–8
Part 11 & data integrity
ALCOA+, audit trails, VSR
You’ll ship: A complete validation pack — URS to summary report — for a real LIMS.
What you produce
A validation pack you wrote yourself.
Every document is reviewed the way an auditor would read it.
Risk assessment
A risk-based analysis that decides where testing effort actually goes.
Traceability matrix
Every requirement linked to its risk, test and result, with no gaps left for an inspector to find.
IQ / OQ / PQ protocols
Test scripts with acceptance criteria, executed on a working system with evidence captured.
Part 11 assessment
Audit trails, e-signatures, access control and records checked against the regulation.
Validation summary report
The closing document that ties the pack together, including how deviations were handled.
How you learn
Validation from the builder’s side.
Taught by a GxP software team
Mentors build and validate regulated software, so you see both the system and the paperwork.
A live system to test
You execute scripts on a working LIMS rather than a slide of screenshots.
Document reviews
Written feedback on your URS, protocols and reports, as a QA reviewer would give it.
Risk-based thinking
How GAMP 5 and Computer Software Assurance ideas help you test what matters most.
Live online for professionals
Sessions you can join from anywhere in India, with recordings for revision.
Interview and audit readiness
Practice explaining your validation decisions the way you would to an interviewer or inspector.
Is this for you?
A good fit if…
- You work in pharma QA, QC, IT or a CRO and are asked to validate computerised systems.
- You are a life-science or pharmacy graduate aiming for CSV or QA roles.
- You are a developer or tester moving into regulated software.
- You want to practise on a real system and have your documents reviewed.
FAQ
Common questions.
What is the fee for the computer system validation course?
Fees depend on the track and format; contact us for the current fee and batch dates.
Who should take GAMP 5 training?
QA, QC and IT professionals in pharma, biotech, labs and CROs, plus life-science graduates and testers who want to work on validated systems.
Does the CSV course cover 21 CFR Part 11?
Yes. One module covers Part 11 requirements such as audit trails, electronic signatures and access control, along with EU Annex 11 concepts and ALCOA+ data integrity.
Do I need a coding background for the validation course?
No. The course focuses on validation documents and testing practice; basic comfort with software and spreadsheets is enough.
Do you offer placement after the CSV course?
We help with your portfolio of validation documents, reviews and interview preparation, but we don’t promise jobs.
Is Computer Software Assurance covered?
Yes. We explain how FDA’s risk-based Computer Software Assurance approach relates to traditional CSV and how to apply it sensibly.
Keep reading
Related pages.
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