Braj Nandan Thakur is the Global Product Manager for data analytics and automation software. He works to build roadmaps and strategy for the software that meet and anticipate industry needs and assist companies in their digital transformations. Braj has implemented enterprise-level digital solutions from R&D through to manufacturing. He holds a master’s degree in bioinformatics from the University of Allahabad and a PGDM from the Institute of Management Technology, Hyderabad, India.
21 CFR Part 11 and Annex 11’s purpose is to ensure electronic records and signatures are equivalent to paper-based records and handwritten signatures. Beyond proving equivalency, software used for electronic records and signatures offer benefits like access control, audit trails, data integrity, and easy search and retrieval of information.
Single-source manufacture of biopharmaceuticals is becoming more and more rare. Increasingly, biomanufacturers or “sponsor” companies partner with contract…
Collaboration between biomanufacturers and CDMOs often experiences challenges with data sharing. This presentation highlights the management of heterogenous and asynchronous data and how a data integration platform can improve project lifecycle data management, and collaborative data sharing.
