Corrective Action Preventive Action - CAPA System

Corrective Action Software

Compliance events are often the result of complaints, audits, incidents, adverse events and more within your organization. Effectively manage and address your organization’s adverse events with EtQ’s Corrective Action solution.

Corrective Action Software

EtQ's Corrective and Preventive Action (CAPA) software allows you to generate a corrective action or preventive action request that routes through review, root cause, corrective action taken, and verification stages. This Corrective Action tracking software generates multiple reports automatically, providing an effective mechanism for tracking the source and costs of problems.

The corrective and preventive action module is a central component to achieving compliance for many organizations. EtQ Reliance has a comprehensive CAPA system within the software that provides a methodical process-based approach to conducting corrective actions or preventive actions. From the EtQ Reliance solution, you can select from a variety of CAPA types, whether related to a customer, internal, based from an audit, or one you configure. The initialization of the corrective action forms begin with the basic information about the adverse event that needs investigation. EtQ’s integrated platform enables you to inherit data from other modules, such as complaint handling, audit management, meetings, or any one of the dozens of modules within EtQ Reliance. The form is intuitively laid out to ensure that the user is able to accurately define the nature of the event, and any potential containment.

Risk Management tied into Corrective Action

EtQ’s CAPA software module is built with risk in mind. Risk management and risk assessment are critical components to filtering and determining the severity of an adverse event. Within the EtQ Reliance CAPA module, you can conduct both initial and later risk assessment, using quantitative tools to calculate risk rankings. This helps to further define the criticality of the corrective action, and provides better visibility into which CAPAs are pose the highest risk.

You can't fix what you can't see. Check out the importance of risk assessment

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Built with traceability in mind

The corrective preventive action module is designed with a configurable workflow that guides the CAPA through the process, which is defined and configured to meet your organizations unique needs. From root cause analysis, to the development of action plans, to verification of effectiveness – the corrective action module is designed to provide complete traceability of the data within the record at each phase. The goal for most companies is to be “inspection-ready” – ensuring that there is a clearly defined story of the event from its detection to correction. With EtQ’s CAPA system, you can easily generate a CAPA history report, which provides a snapshot report of the entire event. This way, rather than search across multiple data points within your corrective action system, you can demonstrate your compliance in a single click, with a single report. That is what makes EtQ’s CAPA software module so powerful; it provides the visibility and control to the more central point in your compliance system – the corrective preventive action process.

Click through the workflow to see how EtQ can help.

Launch CAPA System Investigation

  • Active filtration minimizes the number of investigations and optimizes the use of resources
  • Initiate investigations for confirmed adverse events
  • Define instigation activities and assignments
  • Optionally route investigation plan for review and approval
  • Relevant data will automatically be inherited from source applications such as nonconformance, supplier quality, audit management, etc.
  • Automatic dual link between investigation and source application
  • Use risk management to measure and track risk mitigation
  • Automatically lookup and display related investigations
  • Intuitive Drag & Drop configuration of the form, fields, workflow etc. using EtQ Designer in EtQ Reliance

Root Cause Analysis with EtQ's CAPA Software

  • Automatically assign investigation tasks and activities to team members
  • Separate records will be created for each assignment to track and record progress and deliverables
  • Investigation leader will automatically be notified once all assignments have been completed
  • Ability to close investigation at this stage if CAPA is not required

CAPA Software Planning & Approval

  • Initiate CAPA system plan for confirmed investigations
  • Define entire CAPA system plan in one simple intuitive table format
  • CAPA system plan includes assignments to individuals, groups or roles
  • Intuitive graphical workflow options
  • Once the plan has been approved, separate records will automatically be created and assigned based on the plan to track and record progress and deliverables

CAPA Software Verification & Closure

  • CAPA project leader will automatically be notified once all assignments have been completed
  • Additional actions be configured based on completion of activities such as automatic routing or document creation
  • Automatic assignments and notifications for CAPA activity verification
  • Show risk mitigation history
  • Single click to print a PDF record of the complete CAPA history and all related activities

Reporting & Charting with EtQ's CAPA Software

  • Single click to print a PDF record of the complete CAPA history and all related documents and activities
  • Intuitive drag & drop report builder in EtQ Reliance
  • More than 30 out of the box reports and charts
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