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


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

Sweden Office

Erik Lindeberg, 

VP Sales & Marketing

Telephone: +46 70 710 36 52

UK Office (HQ)

Mark Stevens, 

MD Life Science

Telephone: +44 115 924 8475

US Office

Anders Terp, 

MD North America

Telephone: +1 571 220 7645

Indian Office

Erik Warn, 

MD Sigma India

Telephone: +91 733 848 5007

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