White Papers
Upstream and Downstream Data Analysis
©2012 by Aegis Analytical Corp. Traditional lot traceability approaches are not sufficient to enable upstream/downstream correlation analysis for Quality by Design (QbD). As QbD initiatives gain aceptance across life sciences process development and manufacturing organizations, there is an increased need to understand the dynamics of the critical portions of the process stream more fully. View White Paper.
Survey of Life Science Companies Indicate Continued Data Challenges Despite IT Investments
©2009 by Aegis Analytical Corp. If you have made substantial investments into manufacturing data intelligence systems, and you still struggle to access, aggregate and analyze your manufacturing data, you may be interested in reading the results of a recent survey conducted by Aegis Analytical. Aegis polled (with PharmacuticalManufacturing.com) 538 life science professionals to get their opinions on managing and analyzing manufacturing data. View White Paper.
Aegis Analytical Delivers Process Intelligence from Disparate Data Sources
©2009 by ARC Advisory Group. Aegis Analytical provides an integrated manufacturing data management platform and advanced analytics that, together, enable companies in validated industries to improve operational efficiency, accelerate time-to-market, comply with regulatory requirements, and achieve lean supply chain. The company delivers manufacturing process intelligence by aggregating data, contextualizing the data through a data model, and providing appropriate analytics. View White Paper.
Process Excellence - Five Critical Elements of Quality by Design
©2008 by Aegis Analytical Corp. Today's new regulatory environment highlights innovative ideas regarding process development and manufacturing and forces us to think about the practicalities of implementing them. To achieve QbD, manufacturers need to carefully consider the role of five important areas: process understanding, design-space development, design for manufacturing, process improvements, and process upsets. View White Paper.
Process Intelligence: Bridging the Gap Between IT and Manufacturing
©2009 by Aegis Analytical Corp. Today's manufacturers are constantly seeking information to better understand their processes as a means to improve product lifecycle management. They rely primarily on IT departments and systems to gather information, but often find that this information is difficult to gather and correlate, and that IT does not have the necessary resources to provide rapid responses to these requests. Often, manufacturing users must search through mountains of data leading to "spreadsheet madness" that ultimately do not provide an acceptable answer to the problem at hand. IT departments, meanwhile, are challenged to leverage legacy system investments and minimize implementation time, while providing the necessary information for Manufacturing teams. View White Paper.
For On-Demand Data Access, Investigational Analysis and Process Understanding In Bioprocess Development and Manufacturing
©2009 by Aegis Analytical Corp. The Aegis' Discoverant software suite includes a comprehensive set of capabilities that allows life science manufacturers to work with fermentation data in new and powerful ways. This white paper illustrate some examples of these unique capabilities. View White Paper.