Ensure your sites and facilities meet FDA's exacting standards with comprehensive readiness reviews that evaluate infrastructure, systems, and operations against current regulatory expectations.
Your facility is more than walls and equipment—it's an integrated system where design, construction, operation, and maintenance combine to ensure product quality. FDA evaluates facilities not just for current compliance, but for their ability to consistently maintain suitable conditions. One failing system, inadequate control, or design flaw can compromise everything produced within.
Facility readiness reviews go beyond basic inspections. They systematically evaluate how physical infrastructure supports quality operations, how systems maintain required conditions, and how personnel interact with the environment. From new construction to aging infrastructure, from routine operations to major changes, understanding facility compliance status is essential.
Our facility specialists combine engineering expertise with deep regulatory knowledge. We evaluate facilities through FDA's lens while understanding operational realities and business constraints.
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.
Proprietary talent selection of former FDA and industry professionals amplified by a corporate culture of responsiveness and execution.
US Toll-Free: 1-833-FDA-GROUP
International: +001 508 926 8330