Corrective & Preventive Action (CAPA)

Streamline non-conformance, CAPA, and Supplier Corrective Action (SCAR) with best-practice configurable workflows, supplier and customer collaboration, and full audit-trail compliance.

Business Challenge Key Features Business Benefits

Business Challenge

Quality issues stall without a closed-loop process

When non-conformances and quality issues arise, manual, email-driven corrective action makes it hard to drive them to closure. Root causes go unidentified, issues are mishandled or resurface, and cycle times stretch out.

Regulated manufacturers face an added burden: corrective action processes must meet standards such as 21 CFR Part 11, 21 CFR Part 820 and 210-211, and ISO 13485 and 9001 — which manual processes struggle to satisfy with a defensible audit trail.

Key Features

Best-practice CAPA/SCAR, configurable and collaborative

SupplierSoft provides a comprehensive non-conformance and CAPA/SCAR solution that drives continuous improvement.

Best-practice CAPA/SCAR workflowsConfigurable best-practice processes guide CAPA resolution from identification through root cause to closure.
Supplier corrective action (SCAR)Assign CAPAs to suppliers to drive SCAR issues to closure, with configurable security so suppliers see and edit only what's relevant to them.
Customer collaborationAllow customers to initiate a CAPA or take part in resolution, again with configurable security profiles.
Root-cause analysis and process enforcementEnforce root-cause analysis and best-practice steps, with automated email alerts, reminders, and escalations.
Configurable dashboards and reportsBeyond standard CAPA dashboards, build configurable ones in a few clicks to proactively spot issues — no IT involvement.
21 CFR Part 11 compliantThe system meets 21 CFR Part 11 and helps life-science companies and manufacturers meet 21 CFR Part 820, 210-211, ISO 13485, and 9001.
Outlook integrationKeep communications, tasks, and calendar synchronized with a full audit trail.

Business Benefits

Business benefits

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Higher productivity, lower compliance costAutomated CAPA processes eliminate manual work and reduce cost.

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Shorter CAPA/SCAR cycle timesCentral visibility, collaboration, and due-date-driven workflows resolve CAPAs faster.

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Fewer mishandled issuesEnforced root-cause and best-practice steps reduce misidentified and mishandled quality issues.

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Regulatory confidenceA defensible audit trail supports 21 CFR Part 11 and ISO requirements.

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Supplier accountabilitySCAR assignment drives suppliers to closure.

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Proactive qualityConfigurable dashboards surface issues early.

See CAPA/SCAR management in action

We'll walk a non-conformance from root cause to closure, including supplier SCAR and dashboards.

Schedule a live demo