Quality Systems for Life Sciences
PathWise provides Quality Systems training and consulting 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 quality systems solutions help companies to understand the different regulations and standards, be it FDA or ISO, and how they compare to their existing standard operating procedures.
We’ve worked with many companies in the Medical Device industries to solve problems such as:
- Repeat finds of inadequate training
- Poor communication between departments or cites
- Lack of real understanding of the 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 field, and bring an intimate knowledge of the FDA regulation.
Learn more about our solutions for Medical Device or Pharmaceutical companies.
Pharmaceutical
Developing a systematic approach to cGMP compliance isn’t easy. PathWise provides tools, systems, and best practices to simplify regulatory compliance for Pharmaceutical companies.
Medical Devices
The Quality System, QSR, presents a layer of complexity for many Medical Device companies. PathWise has the experience in helping to manage your quality systems that meet the challenges of regulatory compliance for Medical Device companies.
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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