Spark Therapeutics is undergoing digital transformation, with focus on capturing and analyzing data from manual manufacturing processes to improve quality, facilitate continuous improvement, and simplify regulatory reporting. Spark has selected the OSIsoft PI System as the data capturing and archiving platform. In the first phase of this transformation, Spark, with Aztec Technologies, developed a Manual Data Entry Software (MDES) application as an alternative for OSIsoft Manual Logger. MDES is built on the latest web-based technology to provide a modern user experience. The application also provides capability for adding process specific context for the users, and enhanced regulatory mandated functionality such as 21 CFR, Part 11, Electronic Records, Electronic Signature requirements.