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Validation Services
Validation that proves the system works, not that the paperwork exists.
Computerised system validation and assurance, commissioning and qualification, process and cleaning validation, and test method validation for pharmaceutical, biotechnology and device manufacturers.
The problem
Most validation packages are thick in the wrong places.
The common failure is effort spread evenly: hundreds of scripted test steps on low-risk functions, and too little thought about the functions that actually affect product quality or data integrity. Inspectors see through it, and so do the people who have to maintain it.
Regulators have moved the same way. FDA final guidance on computer software assurance for medical device production and quality system software, issued in September 2025, asks manufacturers to concentrate assurance where the risk is. Process validation has been a lifecycle, from process design through continued verification, since FDA 2011 guidance for drugs and biologics; device process validation follows the QMSR and ISO 13485 clause 7.5.6. Analytical method validation for medicines now sits under ICH Q2(R2) and Q14.
We scale the effort to the risk and keep the evidence lean, traceable and defensible.
Talk to a specialist
Tell us the problem. A specialist replies, not a form robot.
What we do
What we deliver.
CSV and CSA
Risk-based validation of GxP computerised systems, from LIMS and eQMS to manufacturing and laboratory software, including 21 CFR Part 11 and data integrity.
What that means for you
- Testing focused where the risk is real
- Supplier evidence used, not repeated
- Part 11 controls verified, not assumed
Commissioning and qualification
IQ, OQ and PQ for equipment, facilities and utilities, with commissioning work carried into qualification.
What that means for you
- Protocols tied to user requirements
- Deviations handled inside the protocol
- Handover packages ready for operations
Process and cleaning validation
Process design, process performance qualification and continued process verification, plus cleaning validation with justified limits.
What that means for you
- A lifecycle approach from stage 1 to stage 3
- Worst-case selection with a written rationale
- Sampling and limits a reviewer can follow
Test method validation
Analytical and test method validation, and method transfer, for QC and device testing laboratories.
What that means for you
- Validation scaled to the purpose of the method
- Transfer protocols that work in the receiving lab
- Aligned to ICH Q2(R2) and Q14 for medicines and CLSI protocols for IVDs
Engagement write-ups appear here only once the client concerned has approved the wording in writing.We do not publish client names or outcomes without that approval.
How it runs
How a validation programme runs.
Inventory and risk assessment
Systems, equipment, processes and methods listed and ranked by impact on quality and data.
Validation plan
Approach, deliverables and acceptance criteria agreed before any protocol is written.
Execution
Protocols written and executed onsite or remotely, with deviations resolved as they arise.
Report and handover
Summary reports, traceability and a maintenance plan handed to your operations team.
Questions
Questions we get asked before the first call.
Can you move us from traditional CSV to CSA?
Yes. We start with a pilot system, show where effort drops and where the evidence gets stronger, and then update your procedures so the approach is repeatable.
Do you work onsite?
Yes, onsite, remote or hybrid depending on the work. Equipment and facility qualification usually needs people on site; much computerised system validation can be done remotely.
Can we bring in a validation engineer rather than a project?
Yes. You can bring in a CSV or CQV engineer on contract through our talent team, run a defined project under a statement of work, or hand us the whole programme.
Which regulations and standards do you work to?
In the US, 21 CFR Parts 11, 210 and 211, and Part 820, the Quality Management System Regulation, which incorporates ISO 13485:2016; in Europe, EU GMP Annex 11 and Annex 15; and industry practice such as ISPE GAMP 5 (second edition), applied in proportion to risk.
Related
Where to go next.
Validation backlog before an inspection?
Tell us the systems and the date. A specialist replies with a plan that fits the time you have.