CAPA Management

Resolve root causes faster by connecting quality events directly to engineering, design, and supplier data, so every corrective action moves at the speed your business demands.

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A Slow CAPA Process is a Competitive Liability
What is CAPA Management?
Corrective and Preventive Action (CAPA) management is the structured process of identifying, investigating, and resolving the root causes of product quality issues and non-conformances. Propel builds that operational backbone directly into the product lifecycle, so modern manufacturers can close quality problems faster, prevent recurrence, and stay audit-ready.
Closed-Loop Issue Resolution
Closed-loop CAPA management connects the initial quality event—complaint, non-conformance, or failed inspection—directly to investigation, action, and effectiveness verification across every affected team.
Cross-Functional Accountability
When CAPA workflows aggregate all relevant inputs in one place with engineering, quality, and supply chain working from the same data, accountability becomes visible and resolution accelerates.
Audit-Ready Records, Always
Regulators consistently cite CAPA as one of the top FDA inspection deficiency areas. Unified product data means always-maintained complete, traceable CAPA records so an audit or inquiry can be satisfied in minutes to hours, not days.

Propel Closes the Loop From Issue to Resolution

Connected Quality Data
Propel connects CAPA directly to engineering, BOMs, and the unified product thread. When a quality event surfaces, teams trace it to the affected part or component immediately without dealing with manual hand-offs or siloed records. Root cause investigation starts with the right data already in front of the right people.
Compliance Built In
Every CAPA action is captured with full audit history and traceability, supporting ISO 13485, 21 CFR Part 820, and 21 CFR Part 11 out of the box. Automated approval matrices, pre-defined compliance templates, and digital FDA submission capabilities keep modern manufacturers a step ahead of regulatory scrutiny.
Intelligent CAPA Workflows
Propel aggregates complaints, NCMRs, and SCARs into configurable CAPA workflows that tell every team member what's required, by whom, and when. AI-powered processing accelerates root-cause analysis, auto-generates training content from SOPs, and helps teams close issues faster while staying audit-ready.
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More Capabilities
Complaints Management
NCMR Processing
Supplier Corrective Action Requests
Document and Change Control
Training Management
Complaints Management
Fully configurable complaint workflows use decision trees to automatically determine global regulatory reportability requirements. This reduces compliance risk and ensures that every complaint is properly evaluated before it escalates, with direct linkage into CAPA for complete issue traceability.
NCMR Processing
Non-Conforming Material Reports capture supplier and material information and integrate directly with CAPA and audit workflows. Failed inspections trigger NCMRs automatically, so no non-conformance slips through without disposition, corrective action, and a clear compliance record.
Supplier Corrective Action Requests
Propel manages Supplier Corrective Action Requests (SCARs) in streamlined, configurable workflows alongside CAPA and NCMR. Quality teams gain a consolidated view of supplier-related corrective activities, improving supplier performance and reducing the time spent coordinating remediation across disconnected systems.
Document and Change Control
Affected document revisions are tied to CAPA workflows with automated approval matrices, real-time redlines, and full audit history. When a corrective action requires an SOP or policy update, Propel links that revision directly to the CAPA record and also drives training assignments automatically.
Training Management
Document revisions auto-trigger training plans such that corrective actions are reinforced through verified learning. Training assignments, quizzes, and completion data flow into quality analytics, giving compliance teams real-time visibility into whether corrective actions have been operationalized across the workforce.
Concept To Customer Solutions for Fast-Moving Product Companies
Propel QMS
Complete quality management system that unifies part, process, and supplier quality to deliver safer products, higher customer satisfaction, and increased profits.
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Propel One
Natively integrated agentic AI automates workflows, surfaces insights, and accelerates every team across PLM, QMS, and PIM from concept to customer.
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Supplier Community
Secure partner management extends quality workflows, BOM collaboration, and supplier onboarding across your value chain so you launch better products faster.
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Surmodics Cut Change Process Time From 278 Days to 73 Days
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Clearing engineering roadblocks
A fully paper-based change and CAPA process requiring five forms and twenty signatures was replaced with a unified PLM/QMS ecosystem on Propel. Surmodics compressed their change cycle by 74% and accelerated change impact assessments by 73% through a phased digital transformation.
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FAQ
How does Propel connect CAPA to engineering and product data?
Propel links quality events directly to the affected BOMs, components, and part records within the unified product thread. When a CAPA is opened, engineering teams are notified immediately and can trace the issue to its source without switching systems. This connection dramatically reduces the time between issue identification and root cause resolution, while ensuring effectiveness.
Can Propel handle CAPA alongside complaints, NCMRs, and SCARs in one system?
Yes. Propel aggregates complaints, non-conforming material reports, and supplier corrective action requests into a single, connected quality workflow. Each event type feeds into the CAPA process with configurable forms, automated routing, and full traceability, so quality teams manage all corrective activity from one platform rather than coordinating across disconnected tools.
How does Propel support CAPA compliance for FDA- and ISO-regulated manufacturers?
Propel is built to support ISO 13485, 21 CFR Part 820, and 21 CFR Part 11 with pre-defined compliance templates, automated approval matrices, and complete audit history on every CAPA record. For medical device manufacturers with adverse event reporting obligations, Propel also supports digital FDA MedWatch submissions with full acknowledgements and traceability.

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