Validation & Qualification

VALIDATION:

With the assistance of our trained validation experts we ensure process reproducibility, user monitoring and safe data management. The Validation approach begins with the first meeting, continues through process analysis, writing of Functional Requirements Specifications (FRS), risk analysis, and SOPs, continues with IQ and OQ, and culminates in a ready for production, validated solution. This process will ensure compliance with FDA and other regulatory Agencies.

 

You benefit from our experience and standardized, yet flexible approach by:  

 

  • Achieving validation faster and at lower cost

  • Ensuring a dependable and maintainable system

  • Establishing validation and meeting audit requirements

QUALIFICATION:

There is an ever increasing awareness of the need for assurance that products are safe and of a consistent quality. Consequently, as a manufacturer, you must document that processes are proven and that equipment is qualified to produce results that meet specifications. Take away the guess work when you need to ensure quality and regulatory compliance. Mitel has qualification protocols and documentation solutions that satisfy the demands of the FDA and other regulatory institutions.

Your benefits from our expertise:  

 

  • Cost savings of a factory-developed qualification protocol

  • Timely production readiness with correct equipment set-up

  • Improved productivity from timely user training

  • Qualified performance with regulatory compliant procedures

  • Qualification documentation meeting regulatory requirements

 

QUALIFICATION PACKAGES (IQ, OQ, PQ)

Our qualification packages are designed to be consistent with the requirements of GMP and other quality systems. Execution of any of our qualification packages by one of our trained service specialists delivers a self-contained solution for new equipment qualification or for re-qualification of equipment that is re-purposed, moved or lacks adequate documentation.

 

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