Computer system validation that holds up under audit, not just at go-live
We plan, execute, and document the validation of your computerized systems against GxP, so every result is accurate, every record is traceable, and every system holds up the moment a regulator asks how you know. From risk assessment through periodic review, compliance is built into the system, not bolted on before an inspection.
Validating systems for global life sciences leaders
Systems we validate
GxP compliance rests on four disciplines
Whatever the system and whatever the regulation, a validation program that actually holds up under audit comes back to the same four things, done consistently rather than once.
Document
Every requirement, test script, deviation, and result is captured with a full, timestamped audit trail, so “it works” is never just a claim.
Qualify
Installation, Operational, and Performance Qualification (IQ/OQ/PQ) prove the system does what its specification says, in the environment it actually runs in.
Secure Data
Data integrity controls built on ALCOA+ principles keep records attributable, legible, and accurate from the moment they’re captured to the day they’re archived.
Maintain
Periodic review and change control keep a validated system in a state of control long after go-live, not just on the day it was signed off.
The lifecycle below shows how these four disciplines map onto a real validation project, from the first requirement to final sign-off.
The validation lifecycle, stage by stage
A rigorous V-model, applied consistently whether we’re validating a LIMS, an ERP module, or a patient-facing app.
User Requirements Specification
We work with your process owners to capture what the system must do, in testable, unambiguous language that becomes the backbone of every test that follows.
Functional & Design Specification
The vendor’s or your team’s design is checked line by line against the URS, with every requirement traced forward before a single test script is written.
Installation Qualification
We verify the system is installed correctly, in the right environment, with the right configuration, matching what was specified and nothing else.
Operational Qualification
Every function is tested against its specification, including edge cases and negative testing, with results captured as objective evidence, not summarized after the fact.
Performance Qualification
The system is proven under real operating conditions, with real users and real process data, that it consistently does what it’s meant to do in production.
Periodic Review & Change Control
Validation doesn’t end at go-live. We schedule periodic reviews and run every change through a controlled process, so the system stays in its validated state for as long as it’s in use.
Three pillars of a validation program that actually holds up
From the first requirement to the final signature.
- URS, FS & DS authoring. We translate business and regulatory requirements into specifications your vendor and your auditors can both work from.
- Protocol authoring & execution. IQ, OQ, and PQ protocols written to be executable, not just theoretical, then run and documented by qualified validation engineers.
- Traceability matrix. Every requirement is traced through design, testing, and sign-off, so a gap is visible long before an inspector finds it.
Documentation built for the standard you’re actually being measured against.
- GAMP 5 categorization. Every system is risk-classified against GAMP 5 categories, so the depth of testing matches the actual risk, not a one-size-fits-all checklist.
- 21 CFR Part 11 & EU Annex 11. Electronic records and signatures are assessed and documented against both frameworks, wherever your systems and data cross borders.
- SOPs & validation master plans. We write the standard operating procedures and master plans that turn a one-off project into a repeatable, auditable program.
Compliance is a state you maintain, not a milestone you pass.
- Periodic review. Scheduled reviews reassess a system’s validated state against how it’s actually being used, catching drift before it becomes a finding.
- Change control. Every patch, configuration change, or upgrade is impact-assessed and, where needed, re-validated before it goes live.
- Data integrity & ALCOA+. Access controls, audit trails, and data governance are reviewed against ALCOA+ principles, not just at validation, but for the life of the system.
Built to the standards regulators actually check
Whether we’re validating a LIMS, an ERP module, or a patient-facing app, these are the frameworks every validation package is measured against.
GAMP 5
Every system is categorized under GAMP 5 (Good Automated Manufacturing Practice), so the scope and depth of testing is proportionate to risk, not a blanket checklist applied regardless of what the system actually does.
21 CFR Part 11
Electronic records and electronic signatures are assessed for authenticity, integrity, and confidentiality, matching the FDA’s requirements for computerized systems used in regulated processes.
EU Annex 11
For systems and data crossing into the EU, we validate against Annex 11’s requirements for computerized systems, including supplier assessment and data integrity throughout the system lifecycle.
ALCOA+ Data Integrity
Attributable, legible, contemporaneous, original, and accurate, plus complete, consistent, enduring, and available: we build data integrity controls around all nine principles, not just the headline five.
The people behind the validation
Mike aligns validation programs with real regulatory and business risk. With 14+ years of technology consulting experience, he has guided pharma and healthcare clients through system implementations that had to be right the first time.
Tom Tsang
Systems Architect
Tom designs the technical backbone of every validated system we touch, from LIMS integrations to ERP configurations, so the architecture itself is built to hold up under IQ, OQ, and PQ.
Rachel Li
Compliance & Data Governance
Rachel leads our compliance and data governance practice, translating GAMP 5, 21 CFR Part 11, and Annex 11 into documentation and controls that pass both internal QA review and regulatory inspection.
Common questions about validation
Installation Qualification (IQ) confirms the system is installed correctly. Operational Qualification (OQ) confirms each function works as specified. Performance Qualification (PQ) confirms the system performs consistently under real operating conditions, with real users and real data.
GAMP 5’s risk-based categorization is built for exactly this question. We assess each system against its intended use and regulatory impact first, then size the validation effort to match, rather than applying the same depth of testing everywhere.
It depends on system complexity and GAMP 5 category, from a few weeks for a low-risk, configured off-the-shelf tool to several months for a bespoke, high-risk system with complex integrations. We scope timelines against your go-live date early, not after testing has already started.
The system enters periodic review and change control. Every patch, configuration change, or upgrade is impact-assessed, and where needed, re-validated, so the system stays in its validated state for as long as it’s in use.
Yes. Retrospective validation and remediation of legacy systems is common work for us, particularly ahead of an audit or after a gap has been identified internally.
Ready to bring your systems into a validated, audit-ready state?
Tell us which systems you’re running and where you are in the lifecycle. We’ll show you the fastest compliant path to sign-off.
