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Computer Systems Assurance & Validation

SUPPORT FOR LIFE SCIENCE PROVIDERS

Support for Life Science
Providers

Computer System Validation to cover all your GMP, GLP, GCP and QA/QC software applications. CompliancePath currently have 30+ active projects globally supporting clients in CSV/CSA compliance. 

Risk based methodology aligned with with new FDA guidance on CSV/CSA “Computer Software Assurance for Manufacturing, Operations and Quality System Software”

Our CSV/CSA approach is critically focussed on your “Intended Use” and impact to:

  • Product Quality
  • Patient Safety
  • Impact to Quality System Integrity

focus areas include

  • GxP Gap Analysis with “roadmap” solution
  • 21 CFR PART 11 Support
  • Data Integrity Assesments
  • Software Hazard Analysis (SHA) incorporating CompliancePath developed risk based methodology to provide cost & time project efficiencies

ACTIVE IN THE INDUSTRY

CompliancePath participates in the ISPE GAMP Americas steering committee and are active in the Scottish Life Science Associations global trade missions.

CompliancePath Principles led the revision to GAMP Good Practice Guide: IT Infrastructure Control and Compliance 2nd Edition released in 2017 which included the new scope of virtualized technologies to cover:

  • Cloud Computing
  • SaaS/IaaS/PaaS cloud based service model
  • The delivery of GxP applications “as a service”
  • Outsourcing and increased use of third-party data centres
  • CompliancePath Provide Qualification of cloud infrastructure from dedicated 3rd party Data Centre vendors to AWS and Azure.