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Corrective Action Management
Modernize Corrective Action Management with Trackmedium eQMS
Trackmedium's eQMS Corrective Action Management module manages the entire process from detection and investigation to resolution and closure. The process was previously known as CAPA. Designed for regulated industries, the module helps organizations ensure ISO and FDA compliance, reduce repeat issues and product recalls, and foster a culture of accountability and continuous improvement.
End-to-End Workflow Automation
Automate the full Corrective Action process from initiation and investigation to action plan routing, approvals, and closure with built-in alerts and escalations.
Root Cause Analysis Tools
Apply industry-standard methods like 5 Whys, Fishbone, and FMEA to uncover and address the true source of quality issues.
Risk-Based Prioritization
Evaluate and prioritize Corrective Actions based on severity, likelihood, and impact to focus resources where they matter most.
Supplier Collaboration via SCARs
Seamlessly issue and track Supplier Corrective Action Requests (SCARs), enabling external stakeholders to participate in Corrective Action resolution securely.
Configurable Forms & Workflows
Tailor Corrective Action forms, data fields, workflows, and notifications using drag-and-drop tools - no coding needed.
Compliance-Ready
Built to support ISO 9001, ISO 13485, FDA 21 CFR Part 11, ICH Q10, and other global regulatory frameworks.
Connected Platform
Trackmedium's eQMS Corrective Action Management module is part of our eQMS platform and fully integrated with other quality modules. It enables seamless connectivity, streamlined workflows, and complete traceability across all your quality processes.
Corrective Action Lifecycle at a Glance
Trackmedium's eQMS Corrective Action Management module supports the complete lifecycle:
Issue Detection, Trigger Corrective Actions from audits, nonconformances, complaints, or risk events.
Investigation & Root Cause Analysis, Identify underlying causes using tools like 5 Whys, Fishbone Diagram, and FMEA.
Risk Evaluation, Prioritize Corrective Actions based on severity, likelihood, and potential impact on quality and safety.
Action Planning & Execution, Assign corrective and preventive actions, define responsibilities, and monitor implementation.
Effectiveness Check, Validate outcomes to ensure the issue is resolved and that corrective actions are working.
Closure, Close the loop with full traceability, documentation, and regulatory readiness.
Built for Quality-Driven Industries
Trackmedium's eQMS Corrective Action Management module is trusted by organizations across both regulated and non-regulated sectors. Whether you need to comply with strict standards or simply want to drive operational excellence, Trackmedium eQMS adapts to your quality goals.
Regulated Industries
Ideal for organizations that must comply with global regulations and standards such as ISO, FDA, and 21 CFR Part 11.
Non-Regulated & Growth-Focused Sectors
Perfect for companies seeking to strengthen quality culture, reduce operational risk, and improve efficiency - even without formal compliance mandates.
Why Trackmedium eQMS?
Maximize Efficiency
Trackmedium's eQMS automated workflows simplify Corrective Action Management, reducing manual effort and minimizing errors for a more productive process.
Gain Real-Time Insights
Track and analyze Corrective Action progress with dynamic dashboards and audit-ready reports, helping to identify trends and prevent recurring issues.
Seamless Integration
Trackmedium's eQMS flexible architecture connects Corrective Action with other quality processes, eliminating data silos and ensuring a unified compliance ecosystem.
What Our Customers Are Saying
Trackmedium eQMS is proud to provide simple, globally accessible quality management solutions across all industries.
"Trackmedium eQMS has all the modules our organization requires to ensure systems are functional, and remain in compliance, while providing visibility and communication to our company. [It] ensured our users were completely trained and the system was operational in a remarkably short amount of time."
Larry Tyler
Quality Systems Manager
Quality Systems Manager
*Source: footnote 1
"The system is purchased with access to all available applications making it flexible to your needs. It is also customisable meaning that where an application doesn't quite fit your needs you can work with the Trackmedium team to easily customise to your requirements. This has made it a valuable and flexible tool in our company."
Catherine Bennett
Head of Quality and ESG
Head of Quality and ESG
*Source: footnote1
"Finally I have found a system that is both highly functional, fully linked between modules and flexible. I have tried many systems over very many years, but never found one that actually meets all my requirements - until Trackmedium. I thoroughly enjoy using this system."
Jane Wymer
QHSE Coordinator
*Source: footnote1
Frequently Asked Questions
What is Corrective Action Management (previously known as CAPA)?
Corrective Action Management is a structured process for identifying, investigating, and resolving nonconformities so they do not happen again. The process was previously called CAPA (Corrective and Preventive Action), and many companies still search for CAPA solutions, which is why we include both terms.
Why do some companies still use the term CAPA?
Although ISO 9001 removed “preventive action” in its 2015 update, industries such as life sciences, automotive, and aerospace still use the word CAPA. Trackmedium uses the modern term Corrective Action Management, while also supporting CAPA terminology to make it easy for organizations familiar with the older standard to find us.
How does Trackmedium Corrective Action Management compare to CAPA solutions from competitors?
Competitors like MasterControl and ETQ emphasize compliance and automation. Trackmedium delivers the same regulatory strength with a faster setup, easier user adoption, and real-time collaboration across teams and suppliers. Unlike traditional CAPA tools, Trackmedium is cloud-based and integrates seamlessly with other QMS processes.
What are the main steps in the Corrective Action process?
The lifecycle includes detection of the issue, investigation, risk evaluation, action planning, implementation, effectiveness verification, and closure. Trackmedium automates these steps, ensuring nothing is missed and every record is audit-ready.
Can Corrective Actions (CAPAs) be linked to other quality processes?
Yes. Corrective Actions can be created from audits, nonconformance reports, customer complaints, or incidents. This integrated approach is a growing trend across QMS platforms because it gives organizations a single source of truth for quality data.
What methods are available for root cause analysis?
Trackmedium supports industry-recognized methods such as Fishbone Diagram, 5-Why Analysis, and 5P Analysis. These structured tools help organizations address the true root cause rather than treating only the symptoms.
How are action items managed and tracked?
Each Corrective Action generates action items with clear owners, deadlines, and verification requirements. Dashboards and automated notifications ensure tasks stay on schedule, a capability highlighted by leading CAPA software providers.
Can a Corrective Action (CAPA) be closed without implementing actions?
Yes. If the record is a duplicate, obsolete, or created in error, it can be closed with justification. This keeps the system clean, avoids wasted effort, and maintains a complete compliance trail.
How is the effectiveness of a Corrective Action verified?
Trackmedium includes a dedicated effectiveness check step. If the solution is proven effective, the record is closed. If not, it can be re-opened, ensuring that only successful actions are finalized. This approach aligns with industry best practices.
Does Trackmedium support supplier corrective actions (SCARs)?
Yes. Organizations can issue Supplier Corrective Action Requests, often still called supplier CAPAs. This feature lets suppliers directly participate in investigations and corrective measures, strengthening the overall supply chain.
How does the module support compliance with ISO and FDA requirements?
Trackmedium ensures full traceability of actions, approvals, and verifications. It supports compliance with ISO 9001, ISO 13485, FDA 21 CFR Part 11, and other standards, helping companies prepare confidently for audits and inspections.
Which industries benefit most from Corrective Action Management (CAPA)?
Regulated industries such as pharmaceuticals, medical devices, automotive, and aerospace rely heavily on CAPA for compliance. Non-regulated sectors like technology, construction, and manufacturing also use it to reduce risks, improve efficiency, and cut costs.
See more questions
Ready to Take Control of Corrective Action Management?
Close the loop on quality issues faster with a modern, integrated Corrective Action Management system.
Close the loop on quality issues faster with a modern, integrated Corrective Action Management system.
