Get processes under control with enterprise manufacturing intelligence

Aggregating and delivering data is essential to getting processes under control, said Bob Di Scipio, president and CEO of Aegis Analytical, as the company released findings about recordkeeping and EMI software use at pharma and biotech companies.
By Renee Robbins September 3, 2009

Aggregating and delivering data is essential to getting processes under control, said Bob Di Scipio, president and CEO of Aegis Analytical. He gave the advice in the third-quarter 2009 Aegis Process Intelligence Post eNewsletter, as the company released findings about recordkeeping at pharmaceutical and biotech companies .

"Manufacturers are realizing that to properly manage a supply chain, they need to achieve control and understanding of each process and production line in their enterprises," said Di Scipio. "Only with each process under control do companies achieve enterprise-wide manufacturing excellence." This need is what EMI software seeks to answer.

AMR Research has suggested that EMI solutions should include the ability to: "aggregate information from a variety of real-time and diverse back-end data sources, including automation, historians, MES operational databases, laboratory information systems, and relational database systems." AMR also recommends that any solution maintain and provide a contextual view for data relationships from disparate sources and analyze data in a useful way.

The U.S. Food and Drug Administration now encourages manufacturers to better use a holistic process data for validation – making the accessibility and analysis of such data more important than ever from a regulatory perspective. However, in a survey Aegis Analytical did with PharmaceuticalManufacturing.com, pharmaceutical and biotech companies reported that among the biggest challenges they face are the amount of time spent gathering data from multiple sources, followed by analyzing data once it has been gathered. Furthermore, more than 24 percent of large life sciences companies store manufacturing data on paper, resulting in additional challenges with data access and analysis, the survey found.

"EMI tools should allow manufacturers to reduce time spent gathering data, so they can focus on process improvement," said DiScipio. With its Discoverant product, Aegis focuses on the intelligence piece of EMI, said DiScipop, enabling manufacturers to solve process problems by making all process data actionable. The company’s fall conference is geared toward helping manufacturers understand and implement a solution.

– Edited by Renee M. Robbins, managing editor, MBT