Regulated IT & Compliance
Systems built to pass inspection.
CSV, GxP, FDA 21 CFR Part 11, SOX, UK GDPR, EU MDR. Compliant systems designed, delivered, and validated by people who've been in the room when the auditors arrive.
Our Depth
You can’t learn this from a textbook.
Regulatory compliance takes years of working inside regulated organisations to understand how regulations translate into practical IT decisions. Which controls actually matter. What inspectors look for versus what the guidance says they look for.
That experience — designing, implementing, and validating systems in environments where an audit finding can halt production — is what we bring. Not theory, but judgement built across hundreds of real compliance decisions.
What We Deliver
Compliance architecture, not compliance theatre.
Eight capabilities that keep your IT estate audit-ready.
Computer System Validation (CSV)
Validation documentation that stands up to inspector scrutiny. Risk-based strategies, IQ/OQ/PQ protocols, and traceability that doesn't fall apart under cross-examination.
GxP-Compliant Architecture
Architectures designed for GMP, GLP, GCP, and GDP from the ground up. Not a standard platform with compliance patched on afterwards.
FDA 21 CFR Part 11
Electronic records, electronic signatures, audit trails, and access controls that meet Part 11 in practice — not just in your validation summary.
SOX IT Controls
IT general controls, application controls, and access governance mapped to your control framework. Tested for audit readiness, not just documented.
UK GDPR & Data Protection
Data Protection Act 2018, UK GDPR, and privacy-by-design built into the systems we deliver. Data governance, retention policies, and subject access request processes that actually work.
EU Regulatory Compliance
EU MDR, IVDR, EU AI Act, and EMA requirements. Systems architecture designed for the regulatory landscape on both sides of the Channel.
Audit Readiness & Support
When the FDA, MHRA, EMA, or ICO arrive, you're ready. Documentation reviews, gap analyses, and on-site support for the days that matter.
Regulatory Change Management
Change control that keeps validated systems compliant through upgrades, patches, and configuration changes. The process that stops good intentions becoming audit findings.
Industries
Regulated industries we serve.
Regulated environments where compliance is not optional.
Life Sciences & Pharma
FDA, MHRA, EMA. GxP validation, Part 11 compliance, and IT architecture for organisations where systems are regulatory assets.
Aerospace & Defence
Supply chain traceability, controlled document handling, and IT infrastructure that meets the control expectations of aerospace and defence programmes.
Manufacturing
Shop-floor systems, MES integration, production data architecture, and IT infrastructure that supports quality and operational excellence.
Financial Services
SOX compliance, data governance, access controls, and IT architecture for organisations where regulatory scrutiny is constant.
Why VFS
Compliance built by practitioners, not theorists.
We’ve sat in audit rooms, reviewed findings, and rebuilt the systems that failed. Our architecture is informed by what inspectors actually look for — not what a framework document says they should.
Compliance isn’t a separate workstream. It’s built into every system from the start. And as AI tools become part of the regulated landscape, the compliance requirements are evolving — validated AI tooling, AI-aware change control, data governance that accounts for model access. We’re already building for that.
Work With Us
Ready to get compliance right?
Start with a compliance assessment. Or bring us in for full validation support. Your regulatory landscape, your terms.
Book a call