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Good Products' eDMS selected by FDAS to support regulatory inspection

Good Products has announced that its g-docs Electronic Document Management Solution has been selected by Food and Drug Analytical Services (FDAS) to give an additional dimension to an existing cGMP facility. This implementation has been beneficial as the timing has coincided with FDAS's inspection by the Medicines and Healthcare products Regulatory Agency (MHRA). The innovative system from Good Products has helped FDAS to successfully show the system to the MHRA during their audit inspection as well as the process that enables regulatory compliant creation, management and storage of regulated documents.

FDAS is an independent contract testing laboratory offering a wide array of chemical and microbiological services to the pharmaceutical and healthcare sectors. 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's 21 CFR Part 11 guidance on electronic records and signatures. In addition, 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.

FDAS selected g-docs from Good Products thanks to the system's capabilities to track document version history, manage approvals and monitor and record changes in a regulatory compliant audit log. Incorporating the validated CoSign digital signature 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.

Following the implementation of g-docs in August 2009, Good Products has supported FDAS through their validation, training and the MHRA inspection. The company ensured that the document sets within g-docs were suitable for the inspection. An independent auditor was also employed to check the validation testing, examine the software development and test the QMS used for the FDAS project, ensuring that it was suitable. At the final stage, Good Products supplied their QA manager as the quality representative for the computer system on the day of the MHRA inspection, in order to answer any questions from the MHRA auditor.


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