Industry Solutions

Biological Product Deviation Reporting

Blood establishments must comply with the FDA's 21 CFR 600.14 and 21 CFR 606.171, which require reporting of any event associated with the manufacturing, testing, processing, packing, labeling, storage, holding or distribution of a licensed biological product or a blood or a blood component. Events in which the safety, purity, or potency of a distributed product may be affected must be reported to the Center for Biologics Evaluation and Research (CBER) within 45 calendar days from the date of discovery of the deviation.

Many blood centers and manufacturers have been challenged with adequately assessing, recording, coding, and reporting BPDRs in a timely fashion and in accordance with FDA mandates. Manual processes and paper-based systems are key factors contributing to these challenges.

TrackWise

TrackWise enables your organization to improve compliance and reduce safety risk by enabling it to record and manage potential deviations, the BPDR processes, and all related investigation and CAPA processes. TrackWise improves the process by providing an integrated system to electronically classify each deviation using product deviation codes that categorize the deviation or unexpected event according to FDA requirements. TrackWise enables your organization to generate all BPDR reports directly from the system, streamlining the reporting process.

With TrackWise, your organization will ensure compliance while employees become more productive as they access records from a user friendly, web-based interface. Integrated dashboards provide detailed work assignments for end users, and built-in trend detection helps your organization's quality unit recognize growing problems before they spiral out of control.

Benefits

  • Ensure compliance with industry regulations, including 21 CFR Part 210, 211, 820, 600, 601, 606, 610, GMPs, ISO standards, and others.
  • Meet FDA's 45 day requirement for BPDR reporting as a result of increased visibility and full automated escalation.
  • Reduce risk of misreporting by enforcing consistent and harmonized processes and procedures across the organization.
  • Eliminate the potential of lost reports by electronically and securely managing all information in a centralized, scalable, and reliable system.
  • Shorten BPDR completion and approval time as a result of automated workflow and electronic signatures.
  • Increase visibility and reduce safety impact by notifying other blood centers automatically when deviations or errors occur.
  • Improve decision-making and increase control by accessing critical information through TrackWise's built-in enterprise reporting system and management dashboards.