Computer Systems Assurance & Validation
SUPPORT FOR LIFE SCIENCE PROVIDERS
Support for Life Science
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:
focus areas include
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: