Initial Assessment and Gap Analysis:We conduct a thorough evaluation of your existing FSVP practices and documentation. This gap analysis identifies deficiencies and areas for improvement to align with FDA requirements.
FSVP Program Development:Our experts assist in crafting a detailed FSVP program tailored to your business needs. We help develop policies, procedures, and verification activities that comply with FDA regulations.
Documentation Support:We guide you in organizing and maintaining essential documentation for FDA audits. This includes ensuring your records of supplier verification and corrective actions are complete and compliant.
Training and Education:Prepare your team with our targeted training sessions on FDA regulations, audit protocols, and best practices. We ensure your staff understands their roles and responsibilities in maintaining FSVP compliance.
Mock Audits and Pre-Audit Reviews:Benefit from our mock audits and pre-audit reviews to simulate the real audit environment. These assessments help identify potential issues and allow you to address them proactively.
Regulatory Change Management:Stay informed of the latest FDA regulations with our ongoing monitoring services. We provide updates and recommendations to ensure your FSVP program remains current and compliant.
Corrective Action Plans:If issues are discovered during our assessments or mock audits, we assist in developing corrective action plans. Our goal is to resolve deficiencies and enhance your FSVP program’s effectiveness.
Ongoing Support and Consultation:Our support extends beyond the audit. We offer continuous consultation to help you maintain compliance, address any emerging issues, and refine your FSVP program as needed.