PRESENTATION
2020 - OSIsoft PI World San Francisco - Life Sciences, Food, Beverage
Sparking Our Digital Transformation: Deployment of a Manual Data Entry System
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 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.
Company
Spark Therapeutics, Inc.
Speaker
Andrew Ambruso
Spark Therapeutics, is a fully integrated, commercial company committed to discovering, developing and delivering gene therapies; we challenge the inevitability of genetic diseases, including blindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases.
Founded in 2013, Spark Therapeutics is the only biotechnology company that has successfully commercialized a gene therapy for a genetic disease (RPE65 mutation-associated retinal dystrophy) in the U.S., bringing a one-time treatment to market.
Company
Aztec Technologies
Speaker
David Stauffer
Vice President at Aztec Technologies