Life Sciences industry is becoming data driven, this journey started more than 15 years ago with an FDA Guidance for Process Analytical Technology (PAT) which then have been followed by numerous guidance. The 4.0 hype is present in Life Sciences both with Industry 4.0 and also we see the initiative by ISPE regarding Pharma 4.0TM Operating Model which define several essentials for digitalization. 1. Plug & Produce – ability to access, contextualize and consume data and information 2. Process Maps – contextualization to make meaning to data using e.g. industry standards like ISA 88/95 3. CPV for continued process verification as a tool to use every batch as a validation batch However, the most important part, which is high up on most pharma companies according to three recent surveys OSIsoft did is Data Integrity. Data Integrity is about data trustworthiness, data access, data interpretation and data quality. To make any impact of Industry 4.0 and Pharma 4.0 it is important to consider for example the Goals and Priorities, the People, the Execution, the culture as well as the technology.
Petter has a M.Sc. in technical chemistry with a specialization towards chemometrics and data science. After his M.Sc. from Umea University, Sweden, Petter joined Umetrics in 1999, where he worked for 17 years with customers in various markets for example Pharmaceutical, Pulp & Paper, Automotive, Semicon and chemical and with applications such as PAT, QbD, early fault detection, predictive analytics, MPC and CPV. Petter was Global Product Manager for Umetrics’ software portfolio, including SIMCA, SIMCA-online and MODDE, and later became their global sales director leading sales and services teams in EMEA, US and Asia.