Consulting
Whether you’re faced with remediation resulting from regulatory findings (FDA 483s or Warning Letter) or your objective is to improve quality and compliance before that happens, PathWise can help.
Our experts work in partnership with your organization to deliver products and services that enable a compliant, effective and efficient Quality Management System.
Services and solutions include:
- CAPA System - PathWise offers a complete package with all of the tools necessary to build and maintain a compliant, effective and efficient CAPA system.
- Form 483 and Warning Letter Remediation - We have the experience to address and remediate your third party audit findings.
- Management Control - Our management control services offer a sound method to audit, validate and quantify the effectiveness of critical business processes.
- Investigation Facilitation - We’ll facilitate your complex investigations using our proven process and expert consultants, at the same time we’ll provide a common language, and a blueprint for your organization to follow during future investigations.
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Auditing - Our consultants will review your policies and procedures, comparing them to current FDA regulations. We’ll identify possible areas of improvement, make specific recommendations and a plan for fixing them.
- Supplier audit programs
- Audit readiness preparation
- Remediation of third party audit findings
We specialize in the following:
We can conduct desk top audits, onsite audits for compliance and execution, or we can fulfill your internal auditing requirements by partnering as your internal auditor.
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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