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Computer system validation, ScotlandComputer system validation for regulated manufacturing
Regulated manufacturers need their computerised systems validated and kept validated, from the first plan to the final report
Records that have to stand up to an audit
For manufacturers working under a quality system, a computerised system has to be validated, and it has to stay validated as the business and the system change. Medical device and other regulated manufacturers need that work done carefully, and done by someone who has done it
The validation work, end to end
Planning
A validation plan scoped to the system, its intended use and your quality system
Risk
Risk-based thinking that shows where testing effort needs to go
Testing
IQ/OQ/PQ protocols, written and executed, with results recorded as you go
Traceability
Requirements linked to tests, so nothing falls through the gaps
Your QA templates
I work to your templates and procedures, so the documents fit how your team already works
The validation lifecycle
Six steps, from the plan to the periodic review
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CSV planning
Service: CSV
The old way: Validation is an afterthought, with no agreed plan for what to test
With the system: A validation plan scoped to the system, its intended use and your quality system
The outcome: Everyone agrees what validated means before testing starts
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Risk assessment
Service: CSV
The old way: Everything is tested equally, or only what is easy to test
With the system: Risk-based thinking shows where testing effort needs to go
The outcome: Effort goes where it matters for product quality and data integrity
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IQ/OQ/PQ protocols
Service: CSV
The old way: Testing is informal and the results are scattered
With the system: Protocols are written and executed, with results recorded as the testing happens
The outcome: A clear record of what was tested and what happened
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Traceability matrix
Service: CSV
The old way: It's hard to show that every requirement was tested
With the system: Requirements are linked to tests, so nothing falls through the gaps
The outcome: Coverage you can show to an auditor
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Validation report
Service: CSV
The old way: The outcome is spread across documents and emails
With the system: A clear summary of what was tested, what was found and the outcome
The outcome: One report your QA team can review
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Periodic review
Service: CSV
The old way: Systems drift away from how they are actually used, and nobody notices
With the system: Validated systems are checked against how they are used
The outcome: Systems stay in a validated state as things change
What you get
- A validation plan and a risk assessment for the system
- IQ/OQ/PQ protocols, written and executed
- A traceability matrix linking requirements to tests
- A validation report with a clear summary of what was tested, what was found and the outcome
- Periodic review, checking validated systems still match how they're used
Questions about validation
Who is this for?
Medical device and other regulated manufacturers working under a quality system who need a computerised system validated, or existing validation brought up to date and kept that way
What do you deliver?
A validation plan, a risk assessment, IQ, OQ and PQ protocols written and executed, a traceability matrix, a validation report and periodic review
What regulations have you worked with?
I've worked in an FDA-regulated environment and done 21 CFR Part 11 training through work, which covers electronic records and signatures
What systems have you validated?
Systems including MES, Polarion and a range of equipment systems
Can you work to our own templates?
Yes, I'm happy to work to your QA templates and procedures so the documents fit how your team already works
Do you work in Scotland?
Yes, I'm based in Glasgow and work with manufacturers in Scotland
How do we start?
Tell me about the system and what your quality team needs, twenty minutes is usually enough to scope it
Get a system validated
Tell me about the system and what your QA team needs, twenty minutes is usually enough to scope it
Book a free 20-minute chatBring the system and its intended use