Solutions

PathWise provides Quality Systems training and consulting for FDA and ISO regulated industries. For over 15 years, we have provided best-practices for QSR’s, cGMP’s, CAPA, ISO 14971, ISO 13485, and other issues impacting the pharmaceutical, nutraceutical and medical device industries.

We specialize in the following quality disciplines:

Corrective Action / Preventive Action

Audit Management

Documenting Investigations

Risk Management

Change Control

Investigations

Quality System Regulation (QSR)

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 industry, and bring an intimate knowledge of FDA regulations.

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• Medical Devices
• Pharmaceuticals
• Nutraceuticals
• Our Methodology

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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