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Validation Protocols

EXPEDITE IMPLEMENTATION OF YOUR INVESTMENT BY REDUCING VALIDATION TIME AND EXPENSE

Managing validation plans across multiple facilities is nothing less than an art form. Whether you are implementing in-process testing solutions within your laboratory or on your production floor, you can rest assured that with ourvalidation services, all regulatory standards of local and international pharmacopeias will be fully upheld.

Our goal is to provide you with a comprehensive and ready-to-use validation offer. By reallocating laboratory resources, you’ll be able to focus your time and resources on value-added activities in your organization.

Validation Protocol Services

On-site validation services are performed by bioMérieux experts, or by our partner, Sequence. Our IOPQ protocols follow international guidelines such as EP/USP, and are fully GxP compliant. The Validation Life Cycle can be customized based on your systems and instrumentation, and can be tailored to meet internal site requirements and user specifications.

If you wish to perform the validation by leveraging your own resources, we will also be happy to provide the necessary validation templates.

 

Installation Qualification Protocol (IQ)
Verify that the equipment meets the design specifications, and that it is properly and safely installed.

 

Operational Qualification Protocol (OQ)
Verify that relevant equipment parts (including hardware, software, and devices) work fully in accordance with your operational procedures.

 

Performance Qualification Protocol (PQ)

Method validation:

Confirm that the method is suitable for the intended application, and can proceed in a reliable manner.

Suitability testing:

Demonstrate that the presence of a particular product, material, or sample matrix does not impact the performance of the method.

 

Validation documentation
• URS completion guide:
   - User Requirement
• Specification (URS)
   - Functional Design
• Specification (FDS)
   - Requirements Traceability Matrix (RTM)
• Customized Validation Documents

Downloads

bioMérieux Services Validation Protocols (Brochure)

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bioMérieux Services Validation Protocols.pdf
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777 KB
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bioMérieux Services (Brochure)

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bioMérieux Services_2.pdf
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2 MB
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application/pdf