Be prepared for an FDA inspection of your Computer Systems

The prospect of an FDA inspection can be intimidating and the consequences of an FDA Warning Letter can have a significant impact on the future of your business.

FDA compliance is no easy feat. Don’t leave it to chance. Get an expert to verify that your systems will pass an FDA inspection.

We know the systems, validation documents, and topics that inspectors are most likely to target and can accurately assess your computer systems and software validation procedures for inspection readiness.

Get help preparing for an inspection

We identified critical compliance gaps and delivered an achievable action plan. As a result, major compliance problems were corrected before the FDA arrived to inspect.

Customer Success Story

A US biotech company needed to prepare a recently acquired manufacturing and R&D facility for its first FDA inspection. The inspection was a critical step in the approval of a new product with blockbuster potential.

We assessed all of the facility’s computer systems, identified critical compliance gaps, and delivered an achievable action plan. As a result, major compliance problems were corrected before the FDA arrived to inspect. This contributed to the on-time launch of what became the company’s biggest product.

Be prepared for an FDA inspection of your computer systems

We’ve helped organizations prepare for FDA inspections for over 20 years.

Our team will:

  • Review your industry, your products, and your markets to determine the quality regulations with which you need to comply. E.g., 21 CFR 11, 21 CFR 820, or 21 CFR 211.
  • Prepare an assessment checklist that focuses on the areas that are most critical for your FDA inspection.
  • Conduct an Inspection Readiness Assessment in a manner similar to a regulator. We ask the same tough questions, inspect your evidence, and challenge your practices.
  • Provide an Assessment Report with ratings for each checklist question.
  • Deliver an inspection readiness action plan with a list of specific, prioritized activities to complete prior to your inspection.

Get Help Preparing For An Inspection

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