We will help you build comprehensive policies, processes, and procedures designed to ensure and maintain high quality processes and remain in a compliant state.
Development and management of controlled documentation (Policy/SOP/WI)
Design and build a PV quality function
Procedural document planning and development
Establish PV training curricula
Oversight of PV performance and quality metrics
Inspection readiness activities
Support sponsor during regulatory inspections and internal and partner PV audits
Create and implement inspection readiness plans
Provide inspection readiness training
Conduct mock inspections
Performance and compliance metrics
Help set realistic compliance and performance metrics
Measure and monitor compliance against metrics
Vendor and partner alliance management and oversight
Vendor selection and implementation
Vendor oversight including development of KPIs, KQls, service level agreements, and budget
Implementation of governance structure
Audit support
Audit of partners, third party vendors, and internal staff