Document control for life sciences

Manage regulated content through each step in the development process from discovery to delivery with effective document control tools.

Document Locator gives companies in life sciences, including pharmaceuticals, biomedicals, and medical device manufacturers, the document control tools necessary to manage regulated content through each step in the development process, from discovery to delivery. It provides the foundation to improve quality and collaboration, and meet FDA regulatory compliance.

Regulatory compliance for life sciences document control

Enact the procedural and administrative controls for compliance with regulations such as 21 CFR Part 11. Structured management of regulated content in research and development, operations, and marketing at pharmaceutical, biotechnology, and other life sciences companies includes the following benefits:

  • Secure document archiving and audit trail
  • Automated workflow for reviews and approvals
  • PDF Creation with digital signatures
  • Analyze document and process trends in integrated reports
  • Scanning of case and research file archives
  • Partner collaboration with secure web-access options
  • Document template management, review, and approval
  • Email notifications
  • Easy search retrieval
  • Protocols, methods, and test record controls

Managing records in life sciences

With Document Locator you can automate reviews and approvals – and capture an audit trail of every event for regulatory and quality overview. Integrated records management allows you to accurately capture, identify, store, and dispose of records properly.

Be eCTD-ready

Be ready for eCTD submissions. Document Locator sets the framework for capturing the required information in an organized environment necessary for future eCTD submissions.

TMF Reference Model made easy

Automate the build-out of folder structures according the TMF Reference Model (Trial Master File Reference Model). The entire TMF Reference Model is a set of instructions on how to arrange a large hierarchical tree and folder structure, with all of the information laid out clearly. It provides a standardized taxonomy and metadata. Much of the structure and properties needed to manage files in accordance with eTMF can be automated in Document Locator.

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