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SureQuality

Regulatory document discrepancy management and control is critical in the pharmaceutical regulatory document process. Verification and validation of document compliance, integrity and completeness must be tightly integrated with all elements of the regulatory document lifecycle. Now with SureQuality, you can ensure that required regulatory documents are not only collected automatically, but are accurate and free from document discrepancies. SureQuality provides a unified document discrepancy management solution that supports all phases of the eTMF regulatory document lifecycle.

SureQuality has modules that address the entire eTMF document lifecycle:

  • Document Discrepancy Discovery
  • Discrepancy Prioritization and Assignment
  • Discrepancy Resolution
  • Discrepancy Auditing
  • Discrepancy Communication

Control clinical trial regulatory documents using SureQuality™

Benefits

  • Minimize study regulatory document compliance risk
  • Enhanced profits through higher quality
  • Lower travel costs and expenses related to on-site auditing

Features

  • Discrepancy Reporting available to all users
  • Collaborative Discrepancy Notification with web based discrepancy application
  • Remote Auditing of Reg Doc archives
  • SureTrial Triple-View™ enables viewing document discrepancies, document and metadata
  • Management Reporting tools and Discrepancy Metrics

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