NuGenesis Technologies and VelQuest, Inc. Announce Integration Partnership
A pressing issue facing laboratory managers in recent years has been the allocation of resources between scientific productivity and GMP compliance. Underlying the challenge is an unwieldy paper trail of hand-written sample preparation and hard copy instruments reports. In addition, FDA regulation 21 CFR Part 11 requires companies operating in a GMP environment to manage electronic records according to the rule.
By operating in a paperless GMP environment, pharmaceutical companies can dramatically improve their scientific productivity, and simultaneously mitigate their compliance risk. The NuGenesis-VelQuest partnership delivers a comprehensive GMP solution to eliminate paper from the scientific data management process. The partnership will leverage NuGenesis Technologies' "print-to-database" instrument data capture solution, with VelQuests' electronic process management system.
The NuGenesis Toolkit allows VelQuest ePMC to programmatically extract result data from reports captured in the NuGenesis SDMS database. VelQuest users can review all laboratory results and supporting data in the context of the procedural detail used to generate the result. Likewise, NuGenesis SDMS users can view laboratory reports and instantly view the sample preparation information associated with individual results. For the first time, customers have an electronic means to perform an electronic audit, from procedure to result, and result to procedure.
"Our customers are looking forward to this partnership which will solve many existing problems of transcription errors, lost data, or reams of paper," says Bernie Prusaczyk, Vice President, Business Development for NuGenesis Technologies. "Prior to the NuGenesis-VelQuest integration, the paperless GMP laboratory was virtually unattainable."
"This collaboration is a significant step towards our goal of integrating with other leading data management tools," says Ed Halpin, Vice President of Business Development for VelQuest. "This integration provides our mutual pharmaceutical customers with substantial return-on-IT by mitigating compliance exposure and maximizing laboratory productivity."
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