Introduction
Validation is a critical process in the safety and quality of products.
FDA's guidance on validation states:
Validation establishes documented evidence, which provides a high degree of assurance that a
specific process will consistently produce a product meeting its predetermined specifications and
quality attributes. The data should be collected using appropriate samples to support test
performance characteristics of accuracy, precision, sensitivity, and specificity, and when
applicable, reportable and reference range(s), and any other applicable performance characteristics.
Process validation is performed to evaluate the performance of a system with regard to its
effectiveness based on the intended purpose, such as meeting the test kit manufacturer's
reagent specifications.
Opulus provides various levels of validation
solution products based on PyroButton Self-powered data-loggers, communication systems, and integrated
software to meet the requirement for the Temperature and/or Temperature/Humidity Validation,
Validation Maintenance, Qualification, & Re-Qualification of incubators, refrigerators,
freezers, warehouses, processing, & quality control facilities.
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