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Developing An Automated GxP Workflow Integrated With 21 CFR Part 11 - Vimarsana News

Developing An Automated GxP Workflow Integrated With 21 CFR Part 11

Developing An Automated GxP Workflow Integrated With 21 CFR Part 11 By Sridhar Sarva, senior general manager, Freyr Moving from paper to paperless in the pharma and life sciences sector Regulated industries like pharma and medical devices are responsible for ensuring the quality and efficacy of their products to safeguard the public health. To do so, organizations are required to comply with applicable GxP workflows from the R&D stage until a drug or device reaches the end user. During this product development and compliance journey, organizations need to document and log/record every action...