GxP's hosted electronic Document Management Solution (eDMS) solution has been implemented by Food and Drug Analytical Services (FDAS) to manage routine quality control (QC) records for its customers.
FDAS is using the X-docs solution to store, manage and control vital records, ensuring regulatory compliance and improving laboratory efficiency to improve their customer offering.
The company required an eDMS to ensure that all manufacturing and testing processes were thoroughly validated and comply with Good Manufacturing Practice (GMP) and FDA 21 CFR Part 11 regulations.
A solution was needed that would keep records created through the drug-manufacturing process, building a complete history of each batch of drug product for safety and regulatory purposes.
FDAS looked to GxPi to implement an eDMS system that was regulatory compliant, ensuring quick and easy access to records, and offering clients and regulatory authorities a secure and transparent view of all product data.
GxPi's X-docs hosted paperless document-management solution is easy to use, ensures regulatory compliance and can be implemented and validated quickly.
The system is GMP compliant, enabling FDAS to manage quality documentation, templates and workflows, versions and revisions and create a full audit trail of all GMP documents.
The X-docs solution also overcomes the costs and complexity of managing traditional server-based solutions.
Through its consultancy services, GxPi also provides GMP and IT expertise to FDAS.
This combination of skills meant that GxPi could provide the FDAS team with an understanding of how the system would operate and the potential benefits before it was selected.
GxPi also provided its IT Quality Manager to act as the quality representative for X-docs during the organisation's recent MHRA inspection, answering questions from auditors on behalf of FDAS to guarantee compliance.
