A consulting firm has developed a preconfigured product life cycle management (PLM) service that medical device companies can rapidly implement. PLM Vivo for Medical Devices features a short set-up time, a structured design control process, and a validated, production-ready software system, enabling it to be implemented by manufacturers in as few as 16 weeks. The service is based on the consulting firm’s data templates, workflows, document templates, computer system validation templates, reports for internal and external audits, and a security model that meets the requirements specified by 21 CFR Part 11. The firm is a member of Oracle’s partner network, and the service is built on Oracle’s Agile PLM application.

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