Audit and Mock Inspection Services Facility Readiness Review Services

Ensure your sites and facilities meet FDA's exacting standards with comprehensive readiness reviews that evaluate infrastructure, systems, and operations against current regulatory expectations.

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Facilities set the foundation for compliance

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.

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Our facility readiness reviews evaluate:

  • Layout and design for intended operations
  • HVAC systems and environmental controls
  • Clean room classification and monitoring
  • Utilities qualification and monitoring
  • Equipment installation and qualification
  • Material and personnel flows
  • Contamination control strategies
  • Cleaning and sanitization programs
  • Pest control effectiveness
  • Maintenance and calibration systems
  • Security and access controls
  • Emergency preparedness
  • Change control for facility modifications

Facility types we assess:

  • Pharmaceutical manufacturing
  • Biologics and cell therapy
  • Medical device assembly
  • Sterile processing
  • Laboratories and testing facilities
  • Warehouses and distribution centers
  • Compounding pharmacies (503A and 503B)

Our facility readiness advantage

  • Regulatory expertise: Know FDA's facility expectations.
  • Engineering insight: Understand system interactions.
  • Risk-based focus: Prioritize critical compliance elements.
  • Practical solutions: Balance compliance with operational needs.

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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 facility readiness services.