ElevateBio is creating and operating a portfolio of cell and gene therapy companies through partnerships with the world’s most innovative scientists and inventors. BaseCamp, in Waltham, MA, is their centralized R&D and manufacturing facility which is structured to rapidly and efficiently build single- and multi- product cell and gene therapy companies. The facility has fully-integrated capabilities, including basic and translational research, process development, cGMP manufacturing, clinical development, regulatory affairs, and commercial operations. The BaseCamp facility’s modernized approach to operations follows Pharma 4.0™ trends and is intended to utilize digitalized platforms like electronic batch records within the manufacturing suites. As part of this initiative, Kneat was implemented as a paperless validation software for the company’s commissioning, qualification, and validation (CQV) effort. Paperless validation software provides a way to streamline and optimize the CQV activities. The implementation of Kneat required cross-functional collaboration across departments to ensure that the software aligned with both the CQV risk-based approach and the company’s supporting Operations systems. The implementation of the software occurred in parallel with the creation of the company’s supporting systems including CQV, asset management, calibration, maintenance, etc. for facilities, utilities, equipment, analytical instruments, and computer systems.