Validation Services

Support

Our validation services

The validation specialists at Rapid Micro Biosystems provide the complete suite of validation services and documents to ensure qualification of Growth Direct™.

Installation and Operational Qualification (IOQ) documents

This package contains the current version of the combined IOQ document. The IQ portion of the document is used to verify that Growth Direct components are present and connected correctly, and that training, user manuals, and draft SOPs are present. The OQ portion enables you to verify software sequence logic and 21 CFR PART 11 compliance for system security, test error messages, and verify all hardware performs as expected. At the end of the IOQ, the Growth Direct System will be qualified in terms of the equipment and software performance.

Performance Qualification (PQ) documents

This package contains the current version of the PQ document. The PQ document is used to verify the accuracy and analytical performance of Growth Direct with known bacteria (US Pharmacopeia specified and environmental isolates). On completion of the PQ, the Growth Direct will be qualified for analytical performance and ready for the Method Qualification phase.

Method Qualification/Method Suitability (MQ/MS) documents

This package contains the current version of the MQ/MS documents. These are used to verify that the Growth Direct works with each of the materials or applications you wish to test (e.g., each water type, in process bioburden, or EM sample). At the end of the MQ, the Growth Direct will be qualified in terms of the system performance for the detection of viable organisms in the product or application tested.

On-site validation support

Rapid Micro Biosystems offers expert resources to support the validation process.