Life Sciences

Life Science and Medical Device organizations face the challenge of authoring, approving and managing compliant documents to support a number of different processes. If you are not utilizing a document management system, maintaining document compliance becomes increasingly more challenging as the company grows. We have developed a series of scalable and compliant document management solutions that will underpin your process.

Compliant Migration and Import

  • Import Documents from External Sources
  • Migrate Documents from Legacy Document Management Systems
  • Capture Emails and Documents on the User's Desktop
  • Complete Document Audit Trail
  • Reporting for System Validation Packages

Quality Document Management

  • Pre-Configured Quality Document Lifecycles
  • 21 CFR Part 11 Electronic signature support
  • Document Distribution
  • Hooks for Training System Integration
  • Periodic Review Notifications
  • Easy to Use Approval
    Matrix

Medical Device Tracking

  • Track Medical Devices Disposition from Distribution
  • Automated Workflow with Dyanamic Fax Creation
  • Automated Physician Follow-Up
  • Workflow that complies with 21 CFR Part 821
  • 21 CFR Part 11 Electronic signature support
  • HIPAA Compliant to ensure patient privacy