Finesse takes the guesswork out of validation by offering TruBio IOQ to complement its open, fully configurable TruBio operating system (TruBio OS).
Upon completing TruBio IOQ, users will establish documented evidence assuring that TruBio OS meets all user requirements and design specifications. TruBio IOQ provides objective evidence that TruBio OS performs consistently and accurately per its intended use and user needs.
TruBio IOQ follows and incorporates established GAMP4 guidelines to ensure that TruBio OS is compliant with FDA’s Title 21 Code of Federal Regulations Parts 11, 210 and 211. TruBio™ IOQ also ensures that the TruBio OS will function as specified in cGMP and cGLP environments.