July 2009

 
 
Aegis Analytical CorporationAegis - Process Intelligence Post, Discover the Power of Manufacturing IntelligenceAegis Analytical Corporation
Q3 2009

 

Enterprise Manufacturing Intelligence Trends
Instead of simply seeing problems, solve them with Discoverant

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. Only with each process under control do companies achieve enterprise-wide manufacturing excellence.

Enter the need for “Enterprise Manufacturing Intelligence” (EMI). EMI is the holistic management of an organization’s manufacturing data – the business goal Aegis has supported for over a decade.  

We focus on the intelligence piece of EMI by enabling manufacturers to solve their process problems by making all process data actionable.

Growing Need for EMI

In its “Guidance for Industry Process Validation: General Principles and Practices,” the FDA now encourages manufacturers to better use holistic process data for validation – making the accessibility and analysis of such data more important than ever from a regulatory perspective. (See Justin Neway’s related article.)

AMR Research has suggested to the industry 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.

EMI tools should allow manufacturers to reduce time spent gathering data, so they can focus on process improvement. We hope to see you at Discover 2009 this Fall to learn more about how your organization can exploit data to transform its manufacturing.   

Bob Di Scipio
President and CEO • Aegis Analytical


Join Colleagues in Colorado for Discover 2009

Learn about making the business case for EMI

This year, Aegis’ annual conference will bring together the Company’s partners, customers and prospects from leading life sciences companies such as Abbott Labs, Bristol Myers Squibb, Eli Lilly, Genzyme and Merck Serono, who rely on Discoverant for EMI that helps realize additional returns on their process IT investments.


Making the Business Case
for Manufacturing Intelligence

October 5th – 8th • St. Julien Hotel, Boulder, CO
Register Today >

This event includes:

  • Hands-on User and Administrator Workshops
  • Customer Case Studies
  • Industry Analyst Insights Presented by Roddy Martin, Vice President and General Manager of AMR Research
  • Discoverant Product Roadmap
  • Developers’ Roundtable Discussion
  • Role-Based Presentation Tracks
  • Executive Roundtable Discussion
  • Networking with Discoverant Colleagues, Industry Peers, and Aegis Developers and Executives


Meeting the Data Fusion
Challenge for EMI

Discoverant offers a low impact alternative
to the data warehouse


Discoverant offers scientists and engineers access to the data they need on demand without creating a physical data warehouse. It is much less expensive, quicker to install, requires less IT staff involvement and has been validated by a dozen of the world’s leading life sciences companies.  

While traditional data warehouses do have their place in manufacturing, they are not sufficient for EMI because users and IT staff still need to worry about adding additional levels of aggregation, ETL processes and dash-boarding that typically increase utility costs and IT staffing. Process improvement initiatives require users to analyze data from all manufacturing related sources, including warehoused data together with the data from PAT instruments and other on-line measurements.

Discoverant can eliminate the need for a physical data warehouse all together by accessing, aggregating and analyzing the data in its existing data stores. Or, it can be used to leverage data that might be stored in a classic data warehouse. Discoverant gets users access to the data they need, including all process-related data types such as replicate, discrete and continuous data. It provides a “virtual data warehouse” that is populated on demand with the data that scientists and engineers need to improve yield, transfer technology and solve problems through better analysis and reporting.

Discoverant provides the following requirements that are missing in traditional data warehouse solutions:

  • Data Context – capture all types of data (continuous, discrete, replicate)
  • Batch Context – provide the ability to compare batches
  • Batch Genealogy – quickly make upstream and downstream comparisons

The result is real-time EMI that enables greater process understanding and predictability, decreased variability, increased yields and supply chain predictability.


Life Science Manufacturers’
Data Challenges Revealed
in Survey

More than 60 percent of companies surveyed reported “moderate” or “significant” variability in their processes despite significant IT investments

survey

Aegis recently conducted a survey with PharmacuticalManufacturing.com of 538 life science professionals to understand current trends associated with collecting and managing manufacturing data.

The survey showed:

  • The biggest challenges are the amount of time spent gathering data from multiple sources, followed by analyzing data once it has been gathered.
  • More than 24% of large life sciences companies store manufacturing data on paper, resulting in additional challenges with data analysis.
  • Large companies have invested more heavily in IT Infrastructure – systems such as LIMS, MES, ERP – yet they still feel they spend too much time collecting data for analysis.

Download Complete Survey Findings >


EMI for Contract Manufacturing

Videos demonstrate effective data aggregation across multiple plant sites

See how EMI can add value to your CMO relationship by helping to keep accurate records and meeting regulatory requirements at multiple locations. Discoverant’s data retrieval and aggregation features allow for automatic SQL generation that puts data in the right context for meaningful analysis.

Two videos share the perspectives of CMOs and sponsors, respectively.

Watch the video:

Collaborating with CMOs (CMO’s Perspective)
Collaborating with CMOs (Sponsor’s Perspective)

 


Putting Global Manufacturing
Data at Your Fingertips

Justin Neway discusses the business case for EMI solutions in a June Pharmaceutical Manufacturing article

This article is based on Dr. Neway’s June 2008 presentation at the Seventh Annual Biological Production Forum in Munich, Germany. It examines the role of on-demand data access, aggregation and analysis in achieving process excellence and shares how an international pharmaceutical company rolled out Discoverant on a global level.

The focus of the article is on the business case and recommended steps for having IT work closely with manufacturing users. The recent IT paradigm shift and the change management and user retooling processes required are specifically examined – providing valuable insight for all process manufacturers considering EMI systems implementations.

Read more online >

 

 


On the Road
Join Aegis at these upcoming
life sciences industry events.

5th Annual Bio Production Forum

Discover 2009, Making the Business Case for Manufacturing Intelligence

IBC's 6th Annual BioProcess International Conference & Exhibition

Achieving the Goals of Quality by Design (QbD): Making Process Validation a Lifestyle Rather Than an Event

MESA 2009 European Plant-To-Enterprise Conference

8th Annual World Drug Manufacturing
Summit 2009

 

       

Aegis Analytical Corporation 1380 Forest Park Circle, Suite 200 Lafayette, CO 80026
303.926.0317 www.aegiscorp.com lfairbanks@aegiscorp.com ©2009 Aegis Analytical Corporation