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, gap assessments and action plans (21 CFR Part 11, EU Annex 11 and GAMP® compliance)

Supplier Audits

Supplier audits (including SaaS, PaaS and co-location for internal and/or third-party service providers

Relaterade filer

 

Compliance and Innovation

1398KB
 

ISPE DIA Workshop Mobile App

968KB
 

ISPE GAMP Nordic GxP compliance for mobile apps

1561KB
 

The Cloud infrastructure Compliance and security

774KB
 

“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, 

Vice President Sales & Marketing

Telephone: +46 70 549 85 04

info.ls@formpipe.com

UK Office (HQ)

Mark Stevens, 

Managing Director, 

Life Science

Telephone: +44 115 924 8475

info.ls@formpipe.com

US Office

Steve Griffith, 

Vice President of US Business Development, 

Life Science

Telephone: +1 571 220 7645

info.ls@formpipe.com

Global Partner Enquiries

Ben Saxton, 

Head of EU Sales, 

Life Science

Telephone: +44 115 924 8475

info.ls@formpipe.com

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