Protocolos de Validación
Agilice la implementación de su inversión reduciendo el tiempo y los gastos de validación
Managing validation plans across multiple facilities is nothing less than an artform. Whether you are implementing in-process testing solutions within your laboratory or on your production floor, you can rest assured that with bioMérieux validation services, all regulatory standards of local and international pharmacopeias will be fully upheld.
Our goal is to enable faster implementation to maximize return on investment, by providing you with a comprehensive and ready-to-use validation offer. By reallocating lab resources, you’ll be able to focus your time and resources on value-added activities in your organization.
On-site validation execution services are performed by bioMérieux experts, or by our partners WW i.e. Sequence Inc. (US market). 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) and their functionalities work fully in accordance with your operational procedures
Performance Qualification Protocol (PQ)
(Microbiology test and validation procedures)
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)
• Validation Documents (IQ,OQ,PQ)
• Customized Validation Documents
