“GXPi 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 UK Biotech

Computer Systems Compliance

Audits, gap assessments and risk-based methodologies providing practical solutions to help our customers achieve GxP compliance with their on premise, hosted, on-demand and mobile technology systems.

  • Subject matter expertise with GxP compliance, quality systems and testing for IS/IT systems including traditional on premise, dedicated hosted, on-demand (cloud) and mobile devices and applications
  • Computer systems compliance audits, gap assessments and action plans (21 CFR Part 11, EU Annex 11 and GAMP® compliance)
  • Computer systems validation (CSV) risk assessment, validation strategy, Validation Master Plan (VMP) preparation and CSV project management
  • Quality Management Systems (QMS) tailored to meet the needs of technology, software (including mobile applications) service providers to GxP regulated customers
  • Experience and proven methodologies for successfully delivering a range of GxP compliance improvement projects to customers working to FDA and EMA regulatory requirements
  • Audits of Software Suppliers, including those offering Software as a Service (SaaS), Infrastructure as a Service (Iaas), Platform as a Service, (PaaS)
  • Network and Infrastructure qualification (including mobile networks)
  • Data centre and Service Provider audits

Case Studies

  • Case Study: Computer Systems QMS Implementation and Enterprise System Validation Project Management Download
  • Case Study: Computer Systems GxP Compliance and Validation Strategy Download

Presentation Papers

  • ICH Q6B -implications for developers of biopharmaceuticals Download
  • Validating an EDMS – the lean and simply compliant way Download
  • The Paperless QMS Download
To find out more or to discuss your requirements please contact us by calling +44 115 924 8475 or email: info.ls@formpipe.com.