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CAPA Program Support

Ensure your CAPA program is on track with support services from Oriel STAT A MATRIX.

Overview

CAPA is a top source of FDA findings – get it right and watch your audit results improve.

CAPA attracts the most regulatory attention because it involves every aspect of your quality system, from processes to products. CAPA is the acronym for corrective actions and preventive action: corrective action is used to fix an existing problem or shortcoming in your quality system, and preventive action is used to stop a future problem (or adverse event) from occurring or recurring. Issues in the CAPA program may indicate broader quality system problems, and they may raise a warning about the ultimate safety and effectiveness of your product.

Benefits of an effective and efficient CAPA program

Companies with effective CAPA programs identify problems, investigate their root causes, document related incidents, and develop improved processes to ensure that the shortcomings do not recur in the future. Companies with effective (also called compliant) and efficient CAPA programs enjoy an added benefit beyond problem solving and better audit findings: their CAPA programs yield data that decision makers can use to improve operating and financial performance and results.

A strong CAPA system will help your organization:

  • Identify quality problems early in the cycle, before they become severe.
  • Reassure regulatory agencies that your company is capable of identifying and resolving issues.
  • Provide objective evidence to regulators that your organization has corrected problems.
  • Control costs and improve customer satisfaction by improving your overall operations.
  • Enhance operational and financial results by optimizing your management system.
  • Comply with the FDA regulations (21 CFR Part 820.100).

Choose from a full range of CAPA support services.

Oriel STAT A MATRIX provides assistance with all phases of the CAPA process. We can also help your organization develop and implement a best-in-class CAPA program. Our expertise includes:

  • Assessing audit readiness with gap assessments and audits of the CAPA program and its associated CAPA documentation.
  • Designing and implementing an effective CAPA program, including development of CAPA procedures, forms, and templates.
  • Formulating CAPA plans and addressing deficiencies with existing CAPA remediation plans.
  • Conducting CAPA and root cause investigations.
  • Assisting CAPA Review Boards and/or providing independent oversight.
  • Building in-house CAPA expertise with focused training and certification.
  • Helping organizations work through a backlog of open CAPAs.

 

Consulting

Our CAPA experts can help your company:

  • Assess the effectiveness of your current CAPA system – before your next audit.
    • An independent review of your CAPA system will show you where your system needs improvement. We can help you create and implement an action plan based on this assessment to ensure that your CAPA system is both effective and efficient.
  • Design and implement a CAPA program and documentation.
  • Create, implement, and document the needed CAPA program structure, standard operating procedures, and processes with assistance from Oriel STAT A MATRIX.
    • Our CAPA experts will help you save time and deploy a CAPA program that works with your existing business structure.
  • Address deficiencies cited in 483s, warning letters, or regulatory audits and inspections.
    • Ensure that your remediation efforts are successful. Oriel STAT A MATRIX will partner with you to meet internal and regulatory remediation deadlines, without putting undo pressure on your in-house team. Our ultimate goal is to see you implement a self-sustaining, effective, and efficient CAPA program.
  • Conduct CAPA investigations.
    • Many firms lack the time, resources, or internal skill sets to conduct effective CAPA investigations. Oriel STAT A MATRIX’s experts can plan and complete your CAPA investigations, so that your company obtains the results it needs to understand the root cause of a problem and take the needed corrective action. We will ensure that updated processes are validated and that all personnel impacted by those processes will be properly trained to sustain the improvements.
  • Develop and implement a CAPA Review Board to provide independent oversight and review.
    • The CAPA Review Board is a cross-functional team tasked with reviewing and monitoring the CAPA system across an organization. Support from Oriel STAT A MATRIX can provide a valuable external perspective and access to CAPA subject matter expertise, improving the Review Board’s results and understanding of their responsibilities.
  • Build your in-house CAPA expertise.
    • Comprehensive training courses on CAPA and Root Cause Analysis will enhance your team's ability to meet CAPA requirements.
    • Consider becoming certified as a CAPA Leader. Professional certification as a CAPA Leader demonstrates your expertise to both your organization and external regulators such as the FDA.

 

Select a course below to learn more or to register.
 
Course Name Public On-site
Complaint Handling, Vigilance Reporting, and Recall Management: From Compliance to Best Practices
Optimizing CAPA Programs for the Medical Device Industry
Root Cause Analysis for Life Science Investigations

This course will give your organization the key tools for establishing a robust process for the initial intake and triage of customer complaints and any subsequent global regulatory reporting, whether an individual case (MDR, vigilance report) or a correction/removal to ensure product quality and/or safety. Click to learn more. 

Corrective and preventive action (CAPA) requirements in FDA-regulated environments can be confusing and difficult to implement.  Learn how to optimize your CAPA Progam to meet requirements and improve your business. Click to learn more.

This course will help you master the entire root cause analysis process, from accurately identifying the root cause of a problem to designing an effective intervention. This practical course goes beyond theory to teach you specific steps and tools so you can immediately apply what you learn. Click to learn more.

Provided below are a variety of practice related white papers, market updates and case studies.

Customized CAPA Training Addresses 483 Findings for a Medical Device Manufacturer

Our team is here to help. Call 1.888.532.6360 or contact us online ›