[Translate to Spanish:] Controlled Document Excellence

[Translate to Spanish:]

Optimize document management and compliance


Strict global regulatory oversight intensifies the pressure as companies struggle to get their products to market while fully meeting regulatory requirements. Failures not only result in product delays, but often erode a company’s public image affecting market share and profits. Finding ways to increase revenues, while maintaining compliance and high levels of product safety is essential to maintaining a competitive edge. Compliance is a state, not an event.


Licensed to Cure for Medical Device (Quality based document control process) optimizes document management in a single, flexible electronic change control process that enables enterprise-wide collaboration to improve operational efficiency.  The structured library helps to manage the whole documents for the quality management system and enforces compliance for creating, managing and storing files in accordance with global regulatory bodies.  It provides a configurable and an easy-to-use solution that helps companies automate and effectively manage document control processes to help ensure compliance with FDA regulations, ISO quality standards, and other global regulatory requirements.


The 3DEXPERIENCE® Platform provides further support by providing central access to the entire document lifecycle from creation through obsolescence.

Principales ventajas

[Translate to Spanish:]

  • Lower costs and streamline operations with a central document repository
  • Personalized document control workflow, document lists, implementation, and templates.
  • Time saving creations with all reusable information, ability to incorporate further documents as required
  • Complete training traceability management, Track progress and status information per document.
  • Realtime collaboration on SOPs update
  • End to end consistency
  • Fully Auditable Change Control
  • Reduce errors and cycle times with automated revision management
  • Seamless Regulatory Compliance for the end to end product activities