Developing Custom Software in a Regulated Environment

1st June 2016

21 CFR Part 11 / Computer System Validation Tier 2 has significant experience of implementing systems to comply with the FDA’s 21 CFR Part 11, of which Computer System Validation (CSV) is one key part.  ‘Computer System Validation’, in summary is the documented process of ensuring that a system does what it is designed to […]

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Secure web portal for 14M Genomics

16th November 2015

14M Genomics is a cancer diagnostic company, based in Cambridge UK and working in partnership with The Wellcome Trust Sanger Institute, to enrich the understanding of the role of cancer genes in the biology of disease. In March 2015, 14M Genomics (14MG) and the European Organisation for Research and Treatment of Cancer (EORTC) announced a […]

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