GxP is a generic term for the compliance and validation process required by Life Science, Biotech and Healthcare organisations that host regulated data or critical applications. GxP compliance ensures that they are secure and always ready for audit and inspection against US 21 CFR Part 11 Electronic Record and Signatures, US & EU GMP Regulations, Health & Life Science impacting ISO guidelines, Eudralex Vol 4. Annex 11, MHRA guidelines and standards, NHS guideline and standards, The Health Insurance Portability and Accountability Act of 1996 (HIPAA), The Health Information Technology for Economic and Clinical Health (HITECH) Act. Gareth Lush, Commercial Director for DataVita said – “We are delighted about this announcement and our appointment of CompliancePath as they have a proven track record of delivering these services in the US. It means DataVita now has a unique offering for customers in the Life Science, Biotech and Healthcare sectors that removes the regulatory burden and enables hosting of IT services in a co-location datacentre.”
Hugh Devine, Managing Director of CompliancePath says – “After successfully proving our business model in the US, we were looking to enable our European customers with the same compelling combination of a validated GxP datacentre and our expertise to help customers transition services and maintain compliance. The GxP Hosting Service from DataVita includes everything a customer in the Life Science, Biotech and Healthcare sectors needs to meet their regulatory requirements in the datacentre, allowing them to focus on their core business.”
With the NHS moving towards Digital Health and Biotech/Life Science firms under increasing regulatory demands, the need for GxP compliance and validation services is increasing at a rate that is outpacing the available expertise. DataVita’s model of an on demand validated datacentre solution is the way forward to ease the pressure and allow the customers to focus on delivering their services.
