WE WORK WITH
21 CFR Part 11Â
ISO 13485Â
GAMP 5
EU GMP Annex 11
FDA CSA guidance
NIST AI RMF
COMPLIANCE, QUALITY AND TRUSTED AI
Four solutions, one standard of evidence
Each engagement is risk-based, documented and built to be audit-ready from the first day, including the AI you adopt.
Computer Software Assurance (CSA)
Risk-based computer system validation and computer software assurance, aligned with GAMP 5, FDA expectations and 21 CFR Part 11. We help healthcare and life sciences organizations establish and maintain computerized systems that are compliant, reliable and inspection-ready. WHAT WE SUPPORT: · Validation strategy and master planning. · CSA adoption and risk-based CSV methodology. · GAMP 5 lifecycle deliverables. · User requirements (URS). · Requirements management. · Risk assessments. · Requirements traceability. · Test planning. · Test execution and documentation. · 21 CFR Part 11 compliance for electronic records and signatures. · Data integrity and audit-ready documentation.
Quality Management Systems
Quality management systems built to ISO 13485 and FDA requirements: procedures, templates and records your team can run day to day, and that hold up in an audit. WHAT WE SUPPORT: · ISO 13485 QMS implementation. · SOP and procedure development. · CAPA and change control processes. · Validation and quality templates.
Audit and Inspection Readiness
Independent checks that your quality system works in practice, before an auditor or inspector tests it. WHAT WE SUPPORT: · Internal audits. · Supplier quality reviews. · CAPA effectiveness reviews. · FDA inspection and ISO audit preparation. · Ongoing compliance monitoring.
Trusted AI in Healthcare
AI in validated systems, without the inspection risk. We extend risk-based CSV/CSA to the AI tools and AI features you adopt. WHAT WE SUPPORT: · AI use cases ranked by their impact on patient safety, product quality and data integrity. · Validation of the AI you use: generative AI assistants such as Microsoft Copilot, ChatGPT and Claude, AI features inside vendor software, and your own models. · Change control when a model, prompt or vendor AI feature is updated. · A named, qualified person accountable for every GxP decision AI supports. · Audit trails and Part 11-ready records for AI outputs. · AI governance procedures and templates your quality team can run.
100+
50+
enterprise applications reviewed for CSV compliance
global IT applications with a validation strategy set
years in software and regulated technology, most recently as global process owner for CSV/CSA at GE HealthCare
30+
FOUNDER'S TRACK RECORD AT GE
WHO WE HELP
Why Atriant
Medical device companies​
Led by a former process owner
Your work is led by the former global CSV/CSA process owner at GE HealthCare, who defined the procedures and templates used across the business.
Risk-based, not paperwork-based
Effort goes where patient safety and data integrity are at risk, following GAMP 5 and the FDA's CSA approach.
Pharma
Biotech
Senior, hands-on delivery
You work directly with the founder from the first call to the final report. No hand-off to a junior team.
Ready for trusted AI
Digital health
Validation approaches that extend to cloud, automation, AI tools and vendor AI features, with a person accountable for every GxP decision.
Implementing a new system, moving to CSA, or adopting AI in a GxP process?
Start with a 30-minute conversation. You will speak directly with the founder, not a sales team.