Features

TruBio™ IOQ

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.