CAPA software with built-in AI to enforce corrective actions and prove continuous improvement

Q: What is CAPA software?

CAPA software helps teams capture, investigate, resolve, and document corrective and preventive actions tied to quality, safety, or compliance events.

Q: How does Process Street support CAPA management?

We automate CAPA workflows with task tracking, approval checkpoints, and documentation for root cause, corrective action, and verification.

Q: Can CAPAs be triggered from audits or incidents?

Yes. Launch CAPA workflows directly from audit findings, inspection results, or nonconformance logs.

Q: Can we track effectiveness and prevent recurrence?

Absolutely. Assign verification tasks, document results, and maintain a record of preventive actions.

Q: Does this support compliance and audit prep?

Yes. Time-stamped task logs, approvals, and resolution records ensure CAPAs are audit-ready at all times.

Q: How fast can we get started?

Most teams are live in under a week using templates and onboarding support.

Identify issues, investigate root causes, and track resolutions with Cora, your AI quality and compliance assistant.

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CAPA software with built-in AI to enforce corrective actions and prove continuous improvement

Trusted by more than 3000 companies

What's your biggest CAPA management challenge?

Standardize CAPA processes with structured workflows that guide teams from issue to resolution.

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CAPA shouldn't be an afterthought, it should be a system.

From ISO and FDA audits to internal quality initiatives, a strong CAPA process ensures every issue is identified, resolved, and prevented from recurring. Process Street's CAPA software helps teams manage investigations, track corrective actions, and maintain audit-ready documentation. Automate every step of the cycle so no issue goes unresolved or undocumented.

Organize and control all CAPA documentation

Store incident reports, root cause findings, corrective actions, and verification records in one centralized system with version control and audit logs.

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Organize and control all CAPA documentation

Turn CAPA into repeatable workflows

Trigger CAPA workflows from quality events, audits, or non-conformances. Guide teams through investigation, action, and closure steps with real-time task tracking.

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Reduce risk and ensure issue closure

Assign ownership, track deadlines, and follow through on every task. Set escalation paths for overdue or incomplete actions.

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Ensure traceability with built-in logs and approvals

Capture who did what, when, and why. Maintain a complete record of actions, approvals, and resolution evidence for every CAPA event.

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Meet Cora:
Your AI compliance partner

Cora is your always-on CAPA assistant. Built into Process Street, Cora helps you launch investigations, enforce corrective action steps, and monitor issue resolution.

Initiates CAPA from any source Trigger workflows from audit findings, inspections, or customer complaints
Guides the full CAPA lifecycle Assign root cause tasks, corrective actions, and preventive measures
Monitors status in real time Track resolution progress, overdue tasks, and effectiveness verification
Prepares for audits Export audit-ready logs, task histories, and verification records instantly

With Cora, your CAPA system becomes proactive,
traceable, and audit-ready by default.

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Streamline root cause analysis and investigations

Launch RCA tasks and collect findings using prebuilt forms and workflow steps. Tie every conclusion to a documented corrective action.

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Streamline root cause analysis and investigations

Strengthen cross-functional collaboration

Assign tasks across QA, Engineering, Operations, or Compliance with real-time visibility and structured handoffs.

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Manage effectiveness checks and preventive actions

Set verification criteria, collect results, and document effectiveness for every resolved issue.

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Manage effectiveness checks and preventive actions

Gain oversight with real-time dashboards

Monitor CAPA status, task progress, recurrence trends, and effectiveness rates in one dashboard filtered by site, owner, or department.

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Process Street helps teams close the loop on quality and compliance issues:

Audit finding resolution

Launch CAPAs directly from internal or external audit results and track closure with proof of effectiveness.

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Customer complaint management

Capture complaints, initiate corrective action, and maintain documentation for regulator or customer review.

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Manufacturing nonconformance follow-up

Investigate defects, assign root cause actions, and document resolution in a controlled, traceable system.

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GxP and ISO compliance programs

Ensure documented, verifiable CAPA steps for ISO 9001, ISO 13485, FDA 21 CFR Part 11, and other frameworks.

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Safety or incident response

Tie CAPA workflows to workplace incidents or safety inspections to ensure full follow-through and documentation.

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Regulatory submission or inspection readiness

Generate full CAPA histories, timelines, and outcomes for audit or inspection review.

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Frequently asked questions

Can't find the answer you need? Contact our support team.

What is CAPA software?

How does Process Street support CAPA management?

Can CAPAs be triggered from audits or incidents?

Can we track effectiveness and prevent recurrence?

Does this support compliance and audit prep?

How fast can we get started?

Trusted by 3000+ companies

From life sciences and manufacturing to SaaS and healthcare, Process Street
powers CAPA programs that close the loop and prevent repeat issues.

Data protection & security

ISO27001 compliance

Process Street is ISO 27001 certified, confirming compliance with global standards and a strong commitment to protecting customer data through audited, continuously monitored security controls.

Data protection & security

SOC 2 Type II compliance

Process Street has passed a SOC 2 Type II audit, confirming that it meets various criteria for safeguarding customer data. An independent external auditor has verified the effectiveness of the controls implemented by Process Street.

Healthcare information privacy

HIPAA compliance

HIPAA, a federal law, safeguards patient health information. Process Street's robust security measures include the option for a Business Associate Agreement upon request, ensuring HIPAA compliance.

Data protection & security

AWS CIS compliance

The CIS AWS Foundations Benchmark provides security best practices for AWS environments. Process Street's compliance ensures a secure cloud infrastructure by following established guidelines for configuration and monitoring.

EU Data protection & privacy

GDPR compliance

The General Data Protection Regulation (GDPR) is an EU law designed to protect the privacy of individuals and businesses in the EU economic area. It establishes rules for how personal data is collected and handled. Read our GDPR statement

Data protection & privacy

CCPA compliance

The California Consumer Privacy Act (CCPA) gives California residents more control over their personal data, including rights to access, delete, and opt out of data sales. Process Street ensures compliance through transparent practices.

Security & privacy

Artificial intelligence

Your data is never used to train AI models. Any data read or created by a workflow is exclusive to that particular workflow instance and cannot be accessed otherwise, even from within the same organization.

Data sovereignty & infrastructure

Data residency & private cloud

Choose where your data is stored with support for US, UK, Canada, EU, and UAE regions. Customers can also opt for private cloud deployment in their own VPC for maximum control and security.

Backed by happy clients

With Process Street we've been able to bring documentation to life… allowing us to adapt processes quickly, improve governance and achieve consistent results