“GXPi is committed to continuous improvement and delivering the highest quality software products and solutions to our customers”
Product Quality Manager, GXPi
GXPi is committed to continuous 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 our customers’ expectations and complies with all relevant regulations and standards.
Regulations and Compliance
GXPi’s founders come from a regulatory and compliance background and their extensive experience with the standards and guidelines has been used when setting up our own internal processes. Some of the regulations and guidance we deal with are:
- US FDA: Title 21 CFR Part 11, Electronic Records and Electronic Signatures
- UK MHRA: Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007 – the ‘Orange Guide’
- EU Legislation Eudralex guidelines, e.g. EudraLex – Volume 4 Good Manufacturing Practice (GMP) Guidelines, including Annex 11 Computerised Systems
- Good Automated Manufacturing Practice (GAMP®) from the ISPE
- International Conference on Harmonization (ICH) Guidelines
- 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