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Validation and Qualification Services

Our Validation & Qualification Services provide our clients with documented evidence that confirms the validated or qualified status of their equipment, facility or process. Validation Master Plans and Protocols generated are adequate in scope and in accordance with FDA, USP and ISPE guidelines and recommendations. These are generated by staff with accumulated experience in Validation in the Pharmaceutical industry. Sensitech’s worldwide footprint ensures that Validation or Qualification services provided in other countries take into account the guidelines or expectations of the regulatory agencies present in those countries. Protocols are executed following Good Documentation Practices and the resulting Summary Reports are of superior quality tailored for the specific, equipment, facility or process that is validated or qualified.

 

Benefits
Helps customers conform to FDA regulations
Verifies that your equipment design meets specifications
Ensures your equipment is installed in accordance with the manufacturer’s recommendations and that the appropriate systems and documentation is available to ensure that the equipment can be maintained safely, effectively and consistently
Provides documented verification to show that your equipment will consistently operate within established limits and tolerances thus ensuring processes produce consistent outcomes or results
Download Validation & Qualification Data Sheet (PDF Document)

For more information on these studies and how we can help you comply with 1079 Guidance, complete our online form. Be sure to reference 1079 in the comment section.

 

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