GxPi's x-docs Electronic Document Management Solution Achieves Regulatory Compliance for FDAS
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GxPi has announced that hosted x-docs, the company's hosted electronic Document Management Solution (eDMS) solution, has been successfully implemented by Food and Drug Analytical Services Ltd. (FDAS) to manage routine quality control (QC) records for their customers.
FDAS is using x-docs to store, manage and control vital records, ensuring regulatory compliance and improving laboratory efficiency to improve their customer offering.
FDAS is an independent contract testing laboratory serving the pharmaceutical, biopharmaceutical, veterinary and nutraceuticals sectors and primarily offers routine QC and stability testing throughout the drug manufacturing lifecycle.
The company required an eDMS to ensure that all manufacturing and testing processes are 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 access to records and offering clients and regulatory authorities a secure and transparent view of all product data.
GxPi says that its x-docs hosted paperless document management solution 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 both 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 their 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. There were no reported findings on x-docs from the MHRA audit which is a significant success.
FDAS is using x-docs to store, manage and control vital records, ensuring regulatory compliance and improving laboratory efficiency to improve their customer offering.
FDAS is an independent contract testing laboratory serving the pharmaceutical, biopharmaceutical, veterinary and nutraceuticals sectors and primarily offers routine QC and stability testing throughout the drug manufacturing lifecycle.
The company required an eDMS to ensure that all manufacturing and testing processes are 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 access to records and offering clients and regulatory authorities a secure and transparent view of all product data.
GxPi says that its x-docs hosted paperless document management solution 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 both 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 their 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. There were no reported findings on x-docs from the MHRA audit which is a significant success.
