CAPA Solutions for Life Sciences

PathWise provides Corrective and Preventive Action, Effectiveness Checking and other Quality Systems training for FDA and ISO regulated industries. Over more than a decade, we have provided best-practices for QSR’s, cGMP’s, CAPA, ISO 14971, ISO13485, and other issues impacting the Life Sciences industry.

Whether you’re facing an FDA warning letter, an uphill battle against the findings of a recent Audit, or wanting to improve quality and compliance, PathWise can help.

Our CAPA solutions help companies to understand the essentials of an effective CAPA system and understand what is required for compliance with the Quality System regulation. We also work with our clients to implement a closed loop continuous improvement system. We focus on transferring skills such as cause analysis and problem prevention.

We’ve worked with many companies in the Medical Device, Pharmaceutical, and Biotechnology industries to solve problems such as:

• Ineffective Corrective Actions
• Continual repeat investigations
• Inadequate Risk Assessments

PathWise not only provides an outside perspective to these issues, we bring proven best-practices, tools, and processes. We’ve studied the best of the best in the life sciences field, and bring an intimate knowledge of the FDA regulations.

Learn more about our solutions for Medical Device or Pharmaceutical companies.

• Medical Devices
• Pharmaceuticals

Through training in PathWise Project Success managers learned a process for the selection and approval of projects. Team leaders and team members acquired the skills to accomplish projects on time and within scope.

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