IQE - CAPA: Managing Non-Conforming Events

MediaLab's IQE application is designed to provide laboratories with the power to automate non-conforming event management processes while reducing cost and supporting the quality improvement program. Our Intuitive Quality Engine (IQE) helps your laboratory meet corrective and preventive action standards as outlined by CAP, Joint Commission, ISO, and other accrediting bodies. Start by using our online form templates or create your own. Allow employees to create events as problems arise. MediaLab will route your event through each phase of the event management lifecycle, from initial event description through closure and change effectiveness evaluations.

Integrated into MediaLab's suite of quality software, IQE blends beautifully with our Document Control, InspectionProof, and Compliance & CE systems. Easily annotate changes to SOPs and policies and provide training updates to lab team members to fulfill change control requirements.

Features include:

  • Template and custom form building to capture the optimum data fields for your laboratory
  • Routing nonconforming events to appropriate individuals
  • Track progress of events as they flow through the CAPA process phases
  • Collaboration functionality with staff in and outside of the lab department
  • Assign corrective and preventive action (CAPA) tasks to employees as desired
  • Automated notifications and escalation options for critical issues
  • Robust reporting and dashboards
  • Cross-laboratory, cross-department, cross-location reporting for "big picture" clarity
  • Collection of approval signatures (meeting 21 CFR Part 11 regulations)
  • Cloud-based, NO MORE PAPER FORMS!
  • Full integration with MediaLab's software modules

Web-Based Convenience

Your data and statistics are accessible for administrators online 24/7 in MediaLab's secure, safe client portal. IQE provides one standardized, centralized system to collect, trend, collate reports, search for events, and more during inspections and audits.

Audit-Ready Records and Reports

Reports and report shortcuts. Trending, tracking, dashboards, easy searching, flagging/sorting/storing events for easy retrieval. Use standard reports or filtered by user defined criteria. View all events by type, location, date, and more. Your data is viewable at the click of a button in real-time, all the time. Export your data into PDF and Excel reports for quality committee presentations.

Cutting Risk and Costs

Repeated non-conforming events and their subsequent investigation and mitigation cause avoidable risks and costly man hours over time, especially without an automated system in place. IQE will help your laboratory easily view and monitor your important metrics within our real-time reports and dashboards to prevent recurrence of nonconformities. Follow-up tasks are scheduled, employees are notified, processes are made efficient.

Process Improvement at its Best

Our risk analysis and root-cause tools aid in the prediction and deterrence of laboratory non-conformities and deviations. Your lab admin team will have the functionality needed to determine changes/improvements needed for effective quality improvement. Embrace the true meaning of continuous quality improvement.

Paperless

No need for paper forms or spreadsheets managing your nonconforming event data. Increase your CAPA productivity using our centralized online system. Supporting documentation for events are uploadable directly in the platform. Save events, reports, screenshots, and signatures directly in the system.

Fully Flexible and Customizable

Use custom forms, custom elements, and data appropriate for entire lab or for different departments. Customize workflows, collaborations, and approval requests.

Role-Driven

Provide access to management team members with permissions appropriate for their role and department. Allow employees to start events without worry. Only those granted permission can see event outcomes, changes, and resolutions.