Webcast presenter Jonathan Gross answered questions about topics such as Industrie 4.0's relevance and FDA requirements for manufacturing execution systems (MES).
“From manufacturing execution to supply chain management” webcast was presented live on Jan. 23, 2019, by Jonathan Gross, from Pemeco Consulting. The webcast can be found here. He supplied written answers to some of those questions that weren’t addressed from the webcast attendees:
Question: Who are your entry points in a company to convince then about the relevancy of Industrie 4.0? In other words, CEO, CIO, COO, or any other executive role.
Answer: The impacts of Industrie 4.0 are pervasive, and different departments (and roles within departments) will have different interests. For example, the CEO has an interest in bridging strategic gaps and meeting or exceeding strategic key performance indicators. The COO has an interest in operational effectiveness and processing efficiencies, as well as in controlling the levers to make operational changes. The CIO has an interest in designing technology solutions that enable and advance the business. To answer the question, there can be many entry points. And, oftentimes, big technology strategy and architecture decisions are made by a committee.
Q: What FDA requirements prevent pharmaceutical companies from moving MES to the cloud?
A: The FDA has requirements relating to data integrity and compliance with processes and procedures. In December of 2018, it published a white paper link that provides guidance to pharmaceutical companies.
