Key Benefits


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

  • Compliance and Innovation
  • ISPE DIA Workshop Mobile App
  • ISPE GAMP Nordic GxP compliance for mobile apps
  • The Cloud infrastructure Compliance and security

“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