Field Level User Guidance for FDA Compliance

Med device companies use PLM to tackle FDA rules and ever changing regulations, while instituting safeguards, create an adverse effect on product lifecycle and time to market. Users need to retain detailed information from training to follow policies and regulations while managing the product data and documentation. Entering bad or unnecessary data may be caught downstream and causing time wasting red-dos, corrections and re-flows of the approval cycle. PLM XL Assist+ provides guideposts for the user within Agile while managing the product data, changes and documents to prevent out of compliance entries and help the user prevent costly downstream mistakes.

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