Validation & Compliance
Need a regulated system validated, or a validation program that holds up in an inspection? Risk-based computer system validation and compliance for pharma, biotech and medical device teams. Aligned with FDA expectations, 21 CFR Part 11, EU Annex 11 and GAMP 5.
What teams come to us for
Validation takes too long
Document-heavy CSV slows every release, and the effort is not tied to real risk.
We are not sure we would pass an inspection
Audit trails, access controls and spreadsheets may not hold up to Part 11 and data integrity scrutiny.
New technology is outpacing our SOPs
Cloud, SaaS, AI and machine learning systems need validation approaches our procedures do not yet cover.
Validation and compliance services
Risk-based software assurance built to the FDA's final CSA guidance. Spend validation effort where patient and product risk is highest.
Learn more →CSV to CSA transitionMove your validation program from document-heavy CSV to the FDA's risk-based CSA model. Less paperwork, and more assurance where risk is highest.
Learn more →Part 11 / CSA readinessA fixed-scope review of your Part 11 controls and CSA maturity. It ends with a board-ready gap report and a prioritized action plan.
Learn more →Data integrityA fixed-scope review of your GxP data integrity posture. It ends in a gap report and a remediation plan, so you find the exposure before an inspector does.
Learn more →Inspection readinessBe ready for an inspection, or respond to one with credibility. We focus on computer systems, data integrity and Part 11.
Learn more →Periodic reviewKeep your systems validated between projects. A recurring, CSA-aligned program maintains a documented state of control.
Learn more →AI/ML & GenAI validationValidate the AI used in regulated quality, manufacturing and lab systems. Assurance is scaled to intended use and process risk.
Learn more →Cloud & vendor qualificationQualify the vendors and cloud platforms your validation depends on. Then keep cloud systems in a validated state as they change.
Learn more →LIMS, MES & manufacturingLab and manufacturing systems are where data integrity is won or lost. We validate them with a focus on high-risk functions.
Learn more →eQMS validationValidate your electronic quality management system as configured for your processes. We work to Part 11, Annex 11 and CSA expectations.
Learn more →CRO & clinical systemsValidate the systems your studies depend on, from protocol to inspection-ready. Evidence is traceable, risk-based and built for sponsor audits.
Learn more →Cell & gene therapyValidate the systems that carry a therapy from collection to infusion. Identity- and safety-critical systems come first.
Learn more →Validated ALM & test managementMove validation off paper and into a validated ALM or test management tool. We set it up, validate it and support your team after go-live.
Learn more →GMP & validation trainingTraining built on the systems your team actually runs: a private curriculum designed around your SOPs, your processes and your inspection history, taught by the practitioners who validate these systems in production.
Learn more →Complaint & supplier qualityGxP consulting and embedded contractors for medical device and diagnostics quality, built to the QMSR and FDA’s current inspection program.
Learn more →GxP systems we’ve validatedSearch 170+ systems across 12 categories that our team has validated.
Learn more →What we deliver
- Regulatory compliance against FDA regulations, GxP, 21 CFR Part 11, EU Annex 11 and GAMP 5
- Risk-based validation aligned with GAMP 5 and FDA Computer Software Assurance (CSA)
- Data integrity assessments and security controls
- IT vendor audits, software validation audits and data integrity audits
- Validation of Excel spreadsheets, ERP, QMS, LIMS, Veeva, SAP and other GxP software
- Clinical systems: Medidata Rave, Oracle InForm (EDC), Veeva Vault eTMF and Veeva Vault CTMS
- Regulatory information management with Veeva Vault RIM Suite
- End-to-end work from lab equipment commissioning and qualification through computer system validation
Systems and tools
- SAP
- Veeva Vault
- Medidata Rave
- Oracle InForm
- TrackWise Digital
- Waters Empower
4 steps, clear deliverables
- 01
Assess
Inventory GxP systems and classify each by intended use and process risk.
You receive: System inventory and risk classification
- 02
Plan
Right-size the validation approach, leveraging vendor evidence where it is justified.
You receive: Validation plan
- 03
Execute
Test high-risk functions first, with scripted and unscripted assurance as risk requires.
You receive: Test evidence and traceability matrix
- 04
Sustain
Keep systems validated through change control and periodic review.
You receive: Audit-ready validation summary report
Want to know what this would take for your systems? Start with a short scoping call.
Current on the rules that change how you validate
- July 2025
- ISPE publishes the GAMP Guide: Artificial Intelligence
- Sept 2025
- FDA finalizes its Computer Software Assurance guidance
- Feb 2026
- QMSR takes effect, aligning device quality rules with ISO 13485
- In draft
- EU GMP Annex 11 revision and new Annex 22 on AI
- HandbookSQA Solution Handbook: IT Validation, Quality, and Compliance for Clinical-Stage Pharma
- GuideSAP S/4HANA Validation Guide for Life Sciences
- Checklist2025 Validation Readiness Checklist: A Comprehensive Cross-Industry Guide
Who we do this for
- Pharma & biopharma
- Biotech
- Medical devices
- Cell & gene therapy
- CROs & clinical
Related services
Questions we hear most
What is computer system validation (CSV)?
CSV confirms that a computer system works correctly and produces results consistent with its intended use. It is required for GxP-regulated systems.
Why does regulatory compliance matter?
Compliance helps ensure products meet safety and quality standards. It also reduces the risk of 483 observations and warning letters.
How do you ensure data integrity?
We run data integrity assessments against ALCOA++ and verify security controls such as audit trails, unique accounts and e-signatures.
Which standards do you work to?
We work to 21 CFR Part 11, EU Annex 11, GAMP 5 and FDA CSA guidance. We also support quality programs under FDA 21 CFR Parts 211 and 820, ISO 13485 and EU MDR.
Related work
Not sure where to start?
A fixed-fee Part 11 and CSA readiness assessment shows your exposure and a prioritized plan.