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Validation
What is Validation?
Why is Validation Required?
Calibration
Commissioning
Temperature Mapping
Design Specification
The Design Specification is a
specification document
that describes how the equipment or system will be built. The Design Specification is linked to the
Installation Qualification
which tests that the correct equipment or system has been supplied and that it has been installed correctly.
The principal benefits that Biometrix can bring to our clients by writing a Design Specification are:
reduced cost and time to achieve a compliant system
improved compliance with the regulations by using a common and comprehensive validation approach
elimination of the need for time-consuming retrospective validation
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Validation Services
Validation Master Plan
Autoclave Cycle Development
Validation Staffing
Validation Protocol
Installation Qualification
Operational Qualification
Performance Qualification
Specification Documents
Design Specification
Functional Specification
User Requirement Specification
Usability Studies
AABB Consulting
Equipment/Systems Capabilities
Autoclave Validation
Calibration Software Validation
Centrifuge Validation
Chromatography Box Validation
Cold Room Validation
Computer Systems Validation
Environmental Chamber Validation
Environmental Room Validation
Filling Machine Validation
Freezer Validation
Glass Washer Validation
Humidity Chamber Validation
Incubator Validation
Laboratory Monitoring System Validation
Mixer Validation
Oven Validation
PLC Validation
Refrigerator Validation
Shaker Validation
Software Validation
Stability Chamber Validation
Stir Plate Validation
Stirrer Validation
Warm Room Validation
Biometrix Corporation
100 Cummings Center, Suite 333A
Beverly, MA
Tel: (978) 338-5263
Fax: (978) 338-5586
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