Germfree Laboratories has a product lifecycle approach to validation. We use our collective industry experience to bring forward a risk, science, engineering and compliance-based approach to validation taking into consideration the inputs to design, manufacturing, quality control, validation and the continued operation and maintenance of the equipment through its lifetime. Our validation engineering team members have a deep understanding of global health authority expectations and work to industry best practices.
Validation Services are Available for Germfree’s Complete Line of Standard Equipment: Factory Acceptance Testing Installation Qualification Operational Qualification Operator Training
Validation Services for Germfree’s Custom Designed Equipment:
Germfree utilizes a matrixed approach to validation for custom equipment as a model for all activities. The model starts with the development of the Validation Master Plan (VMP) which describes and plans the project and it links the User Requirement Specification (URS), Functional Requirement Specification (FRS) and Design Specification to verification and validation activities, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ) and Operational Qualification (OQ). Requirements are mapped to their corresponding testing utilizing a validation trace matrix. A Validation Summary Report (VSR) is provided to summarize the completion of all validation activities, and that all user, functional and design specifications have been met.
For custom equipment, our validation engineering team is involved from the time of project concept through the final validation summary report. Germfree Laboratories Custom Equipment Services Include:
User Requirement Development Support Validation Master Plan Development Design Specification Documents Factory and Site Acceptance Testing Installation Qualification Operational Qualification Validation Trace Matrix Validation Summary Report Operator Training
Germfree supports the initial equipment install and validation but Germfree Validation Services are also available for re-qualification events as required during the product life cycle.
Please contact us for more information about our comprehensive range of validation services.