Errors and Deviations Management

The Joint Commission for Accreditation of Healthcare Organizations (JCAHO) College of American Pathologists (CAP), the American Association of Blood Banks (AABB), and the FDA all require that blood facilities have systems in place to manage the documentation, investigation, and corrective action of errors, accidents, and deviations. Manufacturers are also required to report Biological Product Deviation Reports 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 meeting these requirements as a result of using paper based and manual processes. Failure to implement adequate and reliable systems has resulted in ineffective root cause analysis and repeat problems. Deviation and investigation management is an important component of the overall quality management system and requires an integrated, closed-loop approach.

TrackWise Error Management and Deviation Management Solutions

TrackWise addresses these challenges and enables blood and tissue collection centers and manufacturers to manage errors, accidents, and deviations as part of their enterprise Quality Management System (QMS). With TrackWise, your organization will ensure compliance while your employees become more productive as they access records from a user friendly, web-based interface, completely eliminating paper based forms.

TrackWise ensures zero "missing in action" deviations, improves the biological deviation reporting process, and automates workflow, enabling your organization to reduce deviation cycle time and improve quality.

Benefits

• Ensure compliance with industry regulations, including 21 CFR Part 210, 211, 820, 600, 601, 606, 610, GMPs, ISO standards, and others.
• Reduce risk by enforcing consistent and harmonized processes and procedures across the organization.
• Eliminate the potential of lost information by electronically and securely managing all information in a centralized, scalable, and reliable system.
• Decrease BPDR reporting time and lower costs by consolidating disparate systems, increasing efficiently, and improving quality.
• Increase visibility and reduce safety impact by notifying other blood centers automatically when deviations or errors occur.
• Increase accountability as well as collaboration by assigning investigations to responsible parties and monitoring due dates through interactive dashboards.
• Improve efficiency and reduce record closure time by automating your workflow and implementing fully electronic review and approval processes.
• Take proactive steps to eradicate repeat errors by improving root cause analysis with built-in decision trees and drill-down selection lists.
• Ensure an effective, closed-loop CAPA process by relating problem analysis and root cause to CAPA planning, implementation, and verification, as well as to effectiveness measurement.
• Improve decision-making and increase control by accessing critical information through TrackWise's built-in enterprise reporting system and management dashboards.