Computer system validation is the process of ensuring that any technology component (software or hardware) is fulfilling its purpose in line with the regulatory guidelines for a certain industry. It is especially crucial in FDA-regulated industries like Biotech and Pharma, […]
Computer System Validation
You are working in Pharmaceutical/ Medical device company and heading the Quality, IT or Operations and accountable for the computer systems used in-house. Associating with these highly regulated industries means that regulators such as FDA, MHRA and TGA will scrutinize […]
Few of the mostly used acronyms used by validation professionals in industry are URS (User requirement specification), IQ (Installation qualification, OQ (Operational qualification), PQ (Performance qualification), DQ (Design qualification), UAT (User acceptance testing) and GxP (Good X practice) and many […]
About Regulatory Complaint CSV Pharmaceutical, Life science and healthcare are few of the industries which needs to operate under the scanner of various regulatory and quality bodies. They need to be ready always for rigorous audit sessions to ensure regulatory […]
A structured and defined validation approach is a backbone for successful implementation of the project and identification of issues at an initial stage of product life cycle in regulatory environment. Innovative and precise CSV practices ensure more effective, efficient and […]
Risk assessment, being an integral part of the validation should be robust enough to identify the key risks at initial stage for a successful validation and implementation of the software. Risk assessment with an effective mitigation plan and identified actions […]
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