Qualification / Validation

From protocol development to protocol execution to final documentation, ISC Labs is the industry leader in providing qualification testing that stands up to regulatory audits. Designed to provide the peace of mind you need when shipping your valuable products, our test reports have passed countless FDA audits, having been developed over years of partnership with our clients.

Each test report icludes:

• Summary - overview of the test plan and objective, including scope, acceptance criteria, test set-up, product acceptance criteria, and summary data tables
• Test Data - color graphs, test worksheets, and raw data for all tests performed
• Packing Procedures - written and illustrated instructions for each packing configuration tested. Animated illustrations are also available
• Material Descriptions and Specifications - engineering specifications for all packaging components
• Equipment Description and Calibration Data - full documentation for all equipment used in the qualification
• Protocol - the original protocol and any amendments are included in the appendix. Each protocol will include a purpose, scope, responsibility, test procedure, and acceptance criteria