Computer System Validation
Prove the system works, not that the binder is thick.
Every GxP system you rely on, from your eQMS to your LIMS to the cloud platforms running your trials, has to be validated and stay validated. We assure them the modern way: scaled to real risk, defensible to any inspector, and free of the paperwork that never protected anyone.
Assurance, Not Paperwork
For years, validation meant printing test scripts no one reads. Computer Software Assurance changed the rules, and we validate to risk, not to volume.
The FDA’s Computer Software Assurance guidance rebuilt validation around critical thinking: intense, scripted testing where patient safety and data integrity are on the line, lighter evidence where they are not. Done well, it produces systems that are genuinely reliable and audits that are genuinely fast. We bring that risk-based judgment to GAMP 5, 21 CFR Part 11, and EU Annex 11, so your validation holds up without holding you back.
The Shift
From paperwork marathon to real assurance.
The Old Way
Document for its own sake
- Exhaustive scripts for every function, high risk or not
- Screenshots of features nobody uses
- Vendor testing repeated from scratch
- Binders that impress no one and protect nothing
- Validation as a one-time snapshot
Our Way
Risk-based assurance
- Testing intensity scaled to patient and data risk
- Critical thinking, targeted where it matters
- Credit for validated supplier and platform testing
- Evidence an inspector actually respects
- A validated state maintained across the lifecycle
Capabilities
End to end, plan to retirement.
Strategy
Validation Planning
Validation plans, user and functional requirements, and a risk strategy that sets the right depth before a single test runs.
Risk
Risk Assessment & GAMP 5
System categorization, risk assessments, and supplier evaluations that decide what to test rigorously and what to leverage.
Testing
IQ, OQ & PQ Execution
Installation, operational, and performance qualification with scripted and unscripted testing, and full traceability.
Compliance
Part 11 & Annex 11
Electronic records and signatures, audit trails, and access controls assessed and remediated against both frameworks.
Integrity
Data Integrity
ALCOA+ assessments, audit trail review strategy, and the controls that keep your records defensible over time.
Lifecycle
Lifecycle Governance
Periodic review, change control, remediation of legacy validation, and controlled decommissioning of retired systems.
Systems We Validate
Whatever runs your GxP operation.
From on-premise legacy platforms to modern SaaS, we validate the systems your quality, lab, manufacturing, clinical, and enterprise teams depend on.
Quality & Document
Lab & Manufacturing
Clinical & Safety
Enterprise
Cloud & Infrastructure
Emerging
Work With Us
Validate smarter, not harder.
Tell us which systems you need validated or remediated. We will pair you with a senior validation lead and respond within one business day.
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