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CAPA Software (Corrective and Preventive Action Software )

Optimally, global manufacturers approach compliance and regulatory issues in three steps. First, they remain vigilant for anomalies, actions or conditions that could have an undesirable effect. Second, they act quickly to evaluate the problem, address it and correct it with an action corresponding to its magnitude. Third, they take a long-term strategic approach to continuous improvement by swiftly eliminating the root cause of the issue and preventing it from happening again. CAPA software can help manage this process.

As part of its corrective action software, IQS provides a closed-loop, integrated system that helps manufacturers perform all three of these actions: the IQS CAPA software ably informs and addresses problems and provides the tool to help mitigate recurrence. After using the module to systematize documenting and tackling issues, you can then distribute learnings across the entire company.

Choose between using the industry best-practice workflow that comes with the IQS Corrective Action software or define and build your own.  All IQS quality management and compliance software features seamless integration with other modules within the IQS solution, providing flexible notifications, reporting and approvals that meet the needs of each stakeholder involved.

KEY BENEFITS OF USING IQS CAPA SOFTWARE

IQS Corrective and Preventive Action Software enables you to ensure timely issue management that meets or exceeds both regulatory and customer demands. To do so, it defines corrective and preventive actions, including responsibilities, notifications and escalations; records the impact of each action on your people, process and product; and captures and controls both internal and external failure quality costs.

Because it provides a definitive outline of actions as well as the potential consequences and costs of those actions, you may shift your focus from the “fire-fighting” of corrective actions to the lower-cost actions of prevention and detection.

CORRECTIVE ACTION REQUESTS

When a corrective action becomes necessary, IQS’s comprehensive Corrective and Preventive Action Software will link and track each individual product and process affected by the action. Then, it helps you verify all actions for containment and long-term effectiveness, in part by allowing you to cross-reference actions and issues to search for and identify potential threats of recurrence.

When the action has been implemented, the software records the trend, assigns the task (to an employee, customer or supplier) and documents the response while tracking progress of the remediation and the eventual outcome. It also helps prevent blind spots by rapidly sharing the status of the action with all global stakeholders involved.

ROOT CAUSE

Simply implementing a corrective action is insufficient. The root cause must be determined and terminated in order to prevent the incident from recurring. Using the central knowledge base in the IQS CAPA software, you can determine the root cause of the problem and develop a long-term solution to eliminate it while using a preferred process (e.g., 8D).

In order to do so, you may specify any details related to corrective actions: product, process, documentation, equipment, measuring device, training of employees, expectations and deliverables from and to customers, suppliers, etc., then link each corrective action request to an unlimited number of nonconformances/issues.

APPROVALS

With the IQS CAPA software, you can build your workflows -including the approval process, your way. It allows for unlimited employee, customer and supplier approvals on corrective action requests with electronic signatures, as well as integration with any email client in order to provide serial and parallel workflow approval routing.

IQS CAPA SOFTWARE PROVIDES DATA VISIBILITY OUTPUT

The holistic capabilities of the IQS corrective action software enable you to access and utilize the data in the way that best aids you in preventing, detecting and correcting issues. For example, it allows you to:

  • Analyze data and identify trends in product and process deficiencies to proactively find and eliminate them.
  • Build “action-based” workspaces to simplify follow-up on current, overdue and future problems as well as action items, preventive actions, etc.
  • View every corrective action requested/related to a customer or supplier over time.
  • View due date, delinquency and success reporting of all corrective actions by region, plant, responsibility and more.
  • Report and share corrective actions in industry-standard formats (e.g., 8D, 7D, etc.).

Key IQS Software System Functions

  • Plug and play, out-of-the-box functionality
  • Easy to use and intuitive interface
  • Easy configuration
  • Intelligent visual form builder templates and pre-configured reporting
  • Data visualization and analytics
  • Real-time notifications/validation
  • Cross browser compatible and mobile friendly
  • Collaboration at the form/record level
  • Comprehensive security and electronic signatures

Cloud-based, hosted EQMS

IQS’s browser-based EQMS resides safely in a highly secure environment to deliver these top benefits:

  • Up to date software features and functions
  • Improved reliability and less redundancy
  • Reduced administrative overhead
  • Thorough disaster recovery

LEARN MORE ABOUT THE CORE IQS PROCESSES:



 

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