Quality and Compliance

Quality Policy

GxPi is committed to continual improvement and delivering the highest quality software products and solutions to our customers.

We have developed our Quality Management System on x-docs™ to ensure a consistently high level of quality, which meets or exceeds all relevant regulations and standards.

Regulations and Compliance

GxPi founders come from a regulatory and compliance background so that our development and build processes incorporate that extensive experience with the standards and guidelines, including:

US FDA: Title 21 CFR Part 11, Electronic Records and Electronic Signature
US FDA: Guidance for Industry for Computerized Systems used in Clinical Systems
US FDA: Title 21 CFR on Good Clinical Practices
GAMP 5 from the ISPE
GLP Guidance
GCP Guidance
International Conference on Harmonization (ICH) Guidance
Data Protection expectations as outlined in UK Data Protection Act 1998, EU Directive 95/46/EC and US HHS Title 45 CFR Parts 160 and 164