New Software and IQ/OQ/PQ Validation Procedures for Syngene Systems Help Save Time Achieving 21 CFR, Part 11 and GMP Compliance
Product News Apr 14, 2008
Syngene, a world-leading manufacturer of image analysis solutions, has announced 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.”