cGxPCurrent Good X Practice (FDA compliance; X can mean: Clinical, Laboratory, Manufacturing, Pharmaceutical,)
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QUMAS is the only vendor that offers a suite of products that enables life sciences companies to achieve complete, enterprise-wide compliance with a broad range of regulations and initiatives including 21 CFR Part 11, cGxP, Sarbanes-Oxley, eCTD, Clinical Operations, Regulatory Affairs and Change Control.
The DSA enables pharmaceutical manufacturers to isolate their cGxP and non-cGxP areas on different servers while maintaining a common window to both domains.
In Life Sciences, for example, Ross provides cGxP compliant transaction processing and work flow systems for materials management, manufacturing, financials and the extended life science supply chain.
For this purpose, there are FDA and cGXP regulations that control the manufacturing process from product design up to final packaging.
QUMAS's comprehensive suite of compliance management applications has been developed specifically for regulated industries and ensures corporate compliance with the full spectrum of global regulations, including Investment Company Act 38a-1, the USA PATRIOT Act, Sarbanes Oxley, 21 CFR Part 11 and cGxP.
QUMAS applications include built-in best practices that support a broad range of regulatory requirements including Sarbanes-Oxley, HIPAA, 21 CFR Part 11, cGxP, Six Sigma Content Management and others.