Laboratory Validation

Validation in the analytical laboratory consists of a seemingly unending string of industry standards that can lead to confusion.  Whether it is ICH Q2, ISO 17025, USP <1225> and <1226> or the FDA’s current guidance document for data integrity, Compliance Team has you covered.

Validation in the laboratory covers the laboratory environment itself, the policies, processes and procedures that support testing, calibrations, training, instrumentation, and the data management system before even validating and the test methods.  A complete laboratory solution encompasses all these elements to create a robust environment wherein every test result is unquestionably accurate and reliable.

The test methods themselves must be validated to ensure that the test method has a robust system suitability procedure , and that the test method was designed to meet requirements for accuracy, precision, specificity, robustness, sensitivity, and linearity over its specified range.  A limit of quantitation needs to be defined for quantitative tests, while a limit of detection needs to be defined for qualitative tests. Ideally, the tests should be aligned with an external standard and/or should involve multiple laboratories and multiple analysts to account for potential variations in the process among laboratory sites.

As you can see, validation of analytical methods has more than initially meets the eye, but Compliance Team has the expertise to identify the most direct approach for ensuring compliance to industry standards.  Whether you are a new testing laboratory seeking ISO 17025 registration, you have purchased new laboratory systems, or if you are simply seeking a way to streamline your laboratory service model, Compliance Team can help.

Compliance Team works to ensure that your reported laboratory results are unfailingly reliable.