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Pharmaceutical Processing News
News Release from: Aitken Scientific | Subject: v:kit
Edited by the Processingtalk Editorial
Team on 04 June 2007
Taking control of analytical validation
Aitken Scientific has successfully produced specialist software for the NLG Analytical v:kit series of fully traceable and 21 CFR Part 11 compliant validation kits for HPLC and GC
The NLG Business Development Manager Stephen Luke explained, "Aitken Scientific were selected for this project due to their experience in developing software for laboratory use, in our case with chromatography systems, and their expertise in programming for 21 CFR Part 11 compliance" v:kit provides a cost-effective and timesaving solution for the operational and performance qualification (OQ/PQ) of HPLC and GC instrumentation - key to maintaining regulatory compliance in analytical laboratories
This article was originally published on Processingtalk on 25 Apr 2008 at 8.00am (UK)
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Advanced statistical process analysis for GxP
New in Europe from Aitken Scientific is an advanced statistical process analysis package, the Comply Skyline product, for validated environments in the biotech and pharmaceutical industries
Each kit contains the standard operating procedures, documentation, materials and bespoke software required for data analyses to produce traceable results against user defined pass/fail criteria.
Aitken Scientific adhere to Good Automated Manufacturing Practice (GAMP) guidelines for computer system validation and offer a high quality software development service for companies of all sizes.
Having developed the robust v:kit software, they have been able to supply immediate technical support and seamlessly maintain contact with NLG customers as and when required, regardless of their locality.
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