Computer Validation and Compliance
“With over 30 years’ experience using risk-based methods to provide practical solutions to help our customers achieve GxP compliance with their ‘on premise’, hosted, ‘on-demand’ and mobile computer systems.”
Key Benefits
Expertise
Subject matter expertise with GxP compliance, quality systems and validation testing for IS/IT systems including traditional on premise, dedicated hosted, on-demand (cloud) and mobile devices and applications.
Audit and Actions
Computer systems compliance audits, regulatory inspection readiness, gap assessments and action plans (21 CFR Part 11, EU Annex 11, GDPR and GAMP®).
Supplier Audits
Supplier audits (including SaaS, PaaS and co-location for internal and/or third-party service providers). Due diligence for outsourced organisation structures.
Related Files
“Formpipe has successfully provided a flexible and thorough QA consultancy support and advise service on a variety of strategic IT projects within our business.”
VP, Quality Assurance
