New Software and IQ/OQ/PQ Validation Procedures for Syngene Systems Help Save Time Achieving 21 CFR, Part 11 and GMP Compliance

April 20th 208 Cambridge, UK: Syngene, a world-leading manufacturer of image analysis solutions, is delighted to announce that it has produced new software and validation information for its Dyversity, G:BOX and GeneGnome range of image analysis systems. This makes them ideal for scientists in pharma and biotech companies that want to rapidly attain GMP (Good Manufacturing Practice) compliance for their image analysis data.

Syngene’s expert software development team spent many research hours ensuring both image and written data generated by GeneSnap and GeneTools, Syngene’s powerful image acquisition and analysis software (integral to Dyversity, G:BOX and GeneGnome systems) can be integrated into a 21 Code of Federal Regulations (CFR), Part 11 environment. Additionally, its technical team produced clear, detailed Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) procedures for the Dyversity, G:BOX and GeneGnome systems allowing scientists to quickly and easily validate these image analysers on-site.

Laura Sullivan, Syngene’s Divisional Manager explained: “Syngene has for more than a decade produced market leading gel documentation systems to comply with Good Laboratory Practice (GLP). With the increase in manufacturing of protein and DNA based therapeutics, we have found them being used to generate data in a production, as well as research context. Therefore, we are pleased to provide a vital link in the quality chain with new software and validation information that will help our users achieve GMP compliance with a Syngene system more easily.”

Laura concluded:” Attaining GMP compliance with our systems will allow scientists in pharma and biotech companies to use them to generate high quality data to present to the FDA or other regulatory authorities and means that Syngene’s Dyversity, G:BOX and GeneGnome image analysers can be used with confidence in both the research and manufacturing of biological therapeutics.”

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For Further Information Contact:
Jayne Arthur, Syngene, Beacon House, Nuffield Road, Cambridge, CB4 1TF, UK.
Tel: +44(0) 1223-727123 Fax +44 (0) 1223-727101
Email: jayne.arthur@syngene.com  Web site: www.syngene.com 

Editor Contact:
Dr Sue Pearson, PO Box 170, Hitchin, Hertfordshire SG5 3GD, UK.
Tel/Fax + 44(0) 1462-635327 Email: sue6.pearson@ntlworld.com

Note to Editors

About Syngene

Syngene is a world-leading supplier of integrated imaging solutions for analysis and documentation of gel-based information. Syngene’s systems are used by more than 10,000 research organisations and over 50,000 individual scientists world-wide and include many of the world’s top pharmaceutical companies and major research institutes.

Syngene, founded in 1997 is a division of the Cambridge based Synoptics Group. The Group’s other divisions, Syncroscopy and Synbiosis, specialise in digital imaging solutions for microscopy and microbial applications respectively. Synoptics currently employs over 40 people in its UK and subsidiary operation in Frederick, USA.