Helm Labs helps pharma, biotech, medical device and CRO teams move from document-heavy computer system validation to risk-based CSA — delivering 21 CFR Part 11, EU Annex 11 and Annex 22 compliance with audit-ready evidence.
Specialist computer system validation for life sciences — from a risk-based CSA pilot to Part 11 & Annex 11 data integrity and Annex 22 AI/ML validation.
Shift from document-heavy computer system validation to FDA / GAMP 5 Computer Software Assurance — focusing effort where patient safety and data-integrity risk actually is.
Achieve and evidence compliance with 21 CFR Part 11 and EU GMP Annex 11 — electronic records, e-signatures, audit trails and end-to-end data integrity built on ALCOA+ principles.
AI and machine learning are entering GxP fast, and almost nobody knows how to validate them. We bring your AI/ML systems into GMP compliance under the new EU Annex 22.
The regulators have moved on. Your validation approach should too.
Low-risk, evidence-led engagements that leave your team more capable than we found them.
We review your current validation approach, systems and risk profile to find the fastest, safest wins.
A risk-based CSA strategy and automation blueprint tailored to your processes and regulators.
We build automated qualification and regression suites, with audit-ready evidence.
Continuous validation, enablement and handover so your team owns the new way of working.
We are validation engineers who have spent years inside GxP-regulated programmes — computer system validation, data integrity and audit readiness. When we say you can cut validation effort by 50–70%, it's because we've delivered it, more than once.
Most validation teams know they should automate and adopt CSA. Almost none have the engineering depth to actually do it. That gap is exactly where we live.
Book a no-obligation consultation. We'll find where you can cut effort, reduce risk and get audit-ready — fast.
