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news.GxPi has deployed its hosted electronic document management solution (eDMS), x-docs, in Food and Drug Analytical Services (FDAS), to manage routine quality control (QC) records for its customers.
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FDAS will use x-docs to store, manage and control vital records, ensure regulatory compliance and for laboratory efficiency to improve customer offering.
FDAS needs eDMS to ensure that all manufacturing and testing processes are thoroughly validated and in compliance with good manufacturing practice (GMP) and FDA 21 CFR Part 11 regulations.
GxPi claimed that its x-docs hosted paperless document management solution is easy to use, can ensure regulatory compliance and can be implemented and validated quickly.
The system is GMP compliant and enables FDAS to manage quality documentation, templates and workflows, versions and revisions and create a full audit trail of all GMP documents. Additionally, GxPi also provides IT expertise to FDAS.
Larissa Taylor, technical director at FDAS, said: “As our company communicates with approximately 70 different clients at any one time, it is essential that we have a document management system that is reliable and easy to use.
“During our investigations of eDMS solutions on the market we found that many systems lacked the rigorous network security and validation procedures required by the pharmaceutical industry.
“We selected GxPi’s x-docs system to improve laboratory efficiency and comply with regulatory and legal requirements in a cost-effective way. The consultancy services offered by the company have added further value, enabling us to achieve efficient compliant processes.”