Regulations change, and so do the interpretations and focuses of Regulatory agencies like the FDA, EMA, EPA, and Health and Human Services (CLIA). Aspects of your Validation program, such as risk assessment, process validation and use of statistics, may evolve over time without your company being aware of the evolution. If this happens, it may result in observations, 483 findings, or even an FDA Warning Letter that you were not expecting.
It is our business to stay current with the Regulations and to help you stay current. Globiox experts can perform a gap analysis of your Validation program to ensure that it is up-to-date. And because we serve many customers across the industry, we have an understanding of how the Regulatory agencies are currently interpreting Regulations, and the current focuses during inspections. If we find gaps in your program, we can help you close those gaps, train your staff on the new processes, and implement them.