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Equipment Validation

 

 

Equipment Validation

Equipment validation is particularly vital in medical device industry in manufacturing and testing processes. Equipment used in any production requires qualification and verification. ADB is well equipped with certified professionals with many years of expertise specific to equipment validation projects.

We are thorough in our validation services and ensure the equipment is skillfully validated considering quality parameters to ensure safe and reliable results. ADB validation consultants can assist you with equipment design, its review, selection and installation. We are focused on minimizing failures and ensuring the equipment run reliably and consistently.

Here are the deliverables of our equipment validation projects

  • Master plan for validation project documenting the project procedure in line with the regulatory standards
  • Functional and user specification
  • Risk Assessment – this is essential in validation processes and our services in risk-based validation include: identifying risks in the processes and equipment; impact of failure assessment; and determining the likelihood of risks occurring. A matrix document is derived from the risk assessment indicating the recommended level of qualification
  • Authoring test case protocols
  • Protocol execution: installation qualification; operation qualification; and performance qualification and qualification reports
  • Change control management
  • Preventive maintenance schedules

 

 


Testimonial / What Our Client Say

Andre and his team were professional, focused and sensitive to the timing issues associated with my project. Most importantly, after the project completed Andre and his team did not disappear. As I needed answers and follow up information, his team followed up in a timely and accurate manner. I look forward to using the services again and would recommend them highly.

Erik Emerson, President & CEO at Symplmed



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