Audit and Mock Inspection Services Vendor/Supplier Auditing Services

FDA’s focus on vendor, supplier, and contract manufacturer compliance is tightening. The supply chain is only as strong as its weakest point. To protect yourself and your stakeholders from the consequences of recalls, seizures, injunctions, and other enforcement actions, it is critically important to identify and remediate all compliance issues present in your outsourced operations through comprehensive audits and corrective actions conducted by experienced quality professionals.

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Your quality is only as strong as your weakest supplier

Your compliance profile is only as strong as your weakest external partner. Contract manufacturers, testing labs, component suppliers, distributors, and service vendors all introduce quality and business continuity risk. Regulators expect demonstrable, risk-based oversight.

We plan and perform supplier audits worldwide—remote, onsite, or hybrid—calibrated to product criticality and supplier performance history. Scope can include quality agreements, incoming material controls, change notification practices, data integrity safeguards, capacity management, and business continuity planning. Need rapid qualification ahead of tech transfer or contingency sourcing? We scale quickly.

Audit outputs drive clear approve/conditional/deny decisions, feed your supplier scorecards, and supply the documented oversight regulators look for—while identifying opportunities to improve resilience across multi-tier supply chains.

Our vendor/supplier auditing services include:

  • Vendor/supplier audit plan strategy and creation
  • Vendor/supplier audit execution and project management
  • Vendor/supplier audit plan maintenance and support
  • MDSAP strategies and audit implementation

Our certified, experienced auditors plan, schedule, and execute vendor/supplier quality management audits to identify areas of conformance and nonconformance with applicable global regulations. Following assessment, our experts provide a detailed report including all observations, deficiencies, and a risk-based corrective action plan for improvement.

With an enhancement plan in place, our quality professionals will work closely with you to provide recommendations, resolve compliance issues, track corrective actions, and communicate the status of resolutions with company management. 

VEEVA AUDIT MANAGEMENT SUPPORT Veeva eQMS data entry services

Is your team using Veeva as your eQMS? In addition to conducting audits, we can complete your data entry directly within your Veeva system, saving you significant time and attention.

Our dedicated project support team works directly with our auditors to streamline the process of inputting audit reports into the Veeva platform. We’ll guide your Veeva Administrator through the steps to confer the necessary user permissions in the platform and take care of the audit input on your behalf. 

Contact us to learn more about integrating Veeva management into your auditing service so you can focus on your core operations.

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Why work with The FDA Group?

 
  • Exclusive life science focus and expertise
  • Dedicated account management team
  • Right resource, first time (95% success)
  • 97% client satisfaction
  • Total Quality Guarantee

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Contact us today to learn more about our vendor/supplier auditing services.