CAPA Software

Process-driven CAPA Compliance

The CAPA module from Grand Avenue Software ensures businesses manage corrective and preventive actions effectively. With features like root-cause analysis tracking, action plan creation, and verification of implementation, our software aligns with the needs of medical products companies looking to stay compliant with regulatory requirements.

Streamline CAPA Processes
& Workflow

The CAPA process in Grand Avenue is efficient, effective, and compliant. By automating workflows and organizing tasks, Grand Avenue’s CAPA software helps companies reduce human error, accelerate response times, and document every step in an audit-ready format. Whether it’s preventive or corrective actions, teams can access relevant data, track progress, and implement action items efficiently.

Results-verified CAPA Management Systems

Each CAPA action is verified during implementation. Our software doesn’t just log corrective actions—it tracks them to full resolution. Using data-backed insights, CAPA results are continuously measured and verified, giving businesses confidence in both compliance and quality improvements. A final step of overall verification of CAPA effectiveness helps ensure the completed implementation actions solve the identified problems.

Grand Avenue’s CAPA management system integrates seamlessly into existing workflows, offering users an easy-to-use platform for managing risk and improvement initiatives. With audit trails, tracking features, and root cause analysis, businesses can ensure they meet regulatory guidelines while improving efficiency.

Grand Avenue Software’s clients have seen real, measurable improvements in compliance and productivity since implementing our CAPA module. By allowing teams to track issues, reduce risk, and meet FDA requirements, we’ve become a trusted partner for leading medical device companies.

Grand Avenue’s CAPA module streamlines the submission and tracking of CAPA requests by offering automated workflows that assign tasks, set deadlines, and provide real-time updates. This ensures issues are quickly addressed, tracked, and escalated when necessary, improving compliance and efficiency.

Grand Avenue verifies the effectiveness of CAPA actions by requiring follow-up tasks and effectiveness checks to ensure corrective or preventive measures successfully resolve the identified issue. These steps help ensure compliance and reduce the likelihood of recurring problems.

Grand Avenue’s CAPA module efficiently manages both corrective and preventive actions through its structured workflows. It allows you to track both types of actions, ensuring thorough resolution of issues while helping to prevent future occurrences, all while meeting FDA and ISO requirements.

Grand Avenue’s CAPA workflow helps resolve non-conformities by facilitating issue identification, root cause analysis, and corrective/preventive action implementation. It provides a structured process for investigating issues, ensuring effective resolution and compliance with regulatory standards.

Grand Avenue’s CAPA module ensures compliance with FDA and ISO 13485 by integrating corrective and preventive action (CAPA) workflows. It supports root cause analysis, assigns responsibilities, tracks corrective actions, verification of effectiveness and ensures all steps are documented, meeting regulatory requirements.

CAPA

from Grand Avenue

Out-of-the-box Functionality

  • Web-based submission of CAPA requests.
  • Integrated solution for corrective, preventive and continuous improvement requests.
  • Early review of request to determine validity as a CAPA.
  • Immediate prioritization and backlog management.
  • Detailed root-cause management and action planning.
  • Formal review of proposed action plans.
  • Tracking of individual actions and action effectiveness.
  • CAPA effectiveness verification and follow-on actions.
  • Workflow-driven due dates and reminders based upon the implementation schedule.
  • Integrated storage of requests, documents, markups, evidence, results and verification data.
  • Flexible searching of CAPAs.
  • Up-to-date charts/reports of status and trends.