Today, computerized systems used in production and business processes of an organization constitute an integral component of all biopharmaceutical industries and laboratories - including R&D and production of pharmaceuticals, medical devices, biotech, clinical trials and other industries that serve these fields. The healthcare authorities which inspect the biopharmaceutical products require the manufacturers to demonstrate a quality system that defines a...
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Today, computerized systems used in production and business processes of an organization constitute an integral component of all biopharmaceutical industries and laboratories – including R&D and production of pharmaceuticals, medical devices, biotech, clinical trials and other industries that serve these fields. The healthcare authorities which inspect the biopharmaceutical products require the manufacturers to demonstrate a quality system that defines a comprehensive and homogenous perception for the computerized systems’ which will ensure their consistency, traceability, defined validation processes and full compliance with the regulatory requirements.
Quality Assurance of computerized systems in a regulated environment includes a definition of policy and work procedures, implementation of processes based on software development life-cycle, change control and a constructed validation process which are a direct result of a risk assessment procedure.
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