Good Products has announced that its G-docs Electronic Document Management Solution has been selected by Food and Drug Analytical Services for an existing cGMP facility.
This has coincided with the FDAS inspection by the Medicines and Healthcare products Regulatory Agency (MHRA).
The system enables regulatory compliant creation, management and storage of regulated documents.
In preparation for the MHRA audit and due to the number of regulated documents, FDAS required a validated Electronic Document Management Solution (eDMS) that would provide flexibility in creating and storing documents electronically.
FDAS also sought a system that enabled the addition of electronic signatures in compliance with the FDA 21 CFR Part 11 guidance on electronic records and signatures.
It was essential that a number of client areas could be created within the chosen system so that confidential documents could be accessed only by specific users.
G-docs tracks document version history, manages approvals, and monitors and records changes in a regulatory compliant audit log.
Incorporating the Cosign product, G-docs allows FDAS to apply eSignatures to documents for approval and release.
G-docs is hosted remotely from the laboratory area in a validated data centre with a dedicated secure server that can be accessed by FDAS, minimising capital, implementation and maintenance costs.
The system implemented at FDAS also includes various custom workflows, ensuring that documents are reviewed and approved by the authorised personnel prior to final release and publication.
