Your quality system is only as strong as its weakest link. Yet many organizations operate with false confidence, assuming documented procedures equal actual compliance. The reality? Most quality system failures discovered during FDA inspections were hiding in plain sight—disconnects between procedures and practice, gaps in training effectiveness, or controls that exist on paper but not in operation.
Professional quality system audits provide the objective assessment needed to identify vulnerabilities before they become violations. But not all audits are equal. Checkbox exercises miss the subtleties FDA investigators spot. Internal audits suffer from familiarity bias. Generic consultants lack the regulatory insight to prioritize findings effectively.
Our quality system auditors—including former FDA investigators with decades of inspection experience—know exactly where to look and what matters most. We evaluate not just compliance, but effectiveness, not just documentation, but implementation, not just current state, but sustainability.
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.