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.”
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.
Computer systems compliance audits, regulatory inspection readiness, gap assessments and action plans (21 CFR Part 11, EU Annex 11, GDPR and GAMP®).
Supplier audits (including SaaS, PaaS and co-location for internal and/or third-party service providers). Due diligence for outsourced organisation structures.
“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