Validation is a process of establishing and documenting evidence which provides a high degree of assurance that a product, service, or system accomplishes its intended function. This also involves acceptance of fitness for purpose with end users. All equipment and instruments must meet manufacturer’s or preset standards for operation and performance. We have support and validation for all of our products as well as any products that are supported by PH21 software.
Each of our products are supported by
Installation Qualification (IQ)
All major components are tested, certified and
confirmed by the operator.
Operational Qualification (OQ)
Documentation that the systems works flawlessly
within the limits specified.
Performance Qualification (PQ)
Examination of product-relevant functions with your
tablets or test materials.
Computer System Validation (CSV)
Software validation protocols to document software
functions and 21 CFR, Part 11 compliant operation.
These protocols can be executed by the customer or commissioned to us to be performed on site.