Aegis Analytical Corp. Knowledge Center
Aegis Analytical Corp. provides the only fully integrated manufacturing process management software system that enables manufacturing companies to accelerate products to the market, improve operating efficiencies and satisfy regulatory obligations.
Aegis’ Discoverant software solution presents a complete view of the manufacturing process, from raw materials to finished product, to provide on-demand data access which is then integrated with user-centric investigational analytics and reporting capabilities for all data types.
Quick Facts
Aegis Analytical Corp.
1380 Forest Park Circle
Suite 200
Lafayette, Colo. 80026
USA
www.aegiscorp.com
info@aegiscorp.com
Phone: 303.926.0317
Fax: 303.926.1161
Knowledge Center Featured Solutions
Articles
Balancing Compliance with Economics: The New Role of Manufacturing
By Aegis Analytical Corp.
As process manufacturers search for ways to trim costs and boost revenue – whether that be by increasing yield or speeding time to value – they can view the FDA’s inspections and PAT recommendations as opportunities to better understand manufacturing processes across the organization. Today’s IT tools enable data intensive decision-making that places manufacturing at the center of new initiatives that drive a synergistic balance between compliance and the bottom line.
Get This Now »Better Process Understanding Improves Quality, Lowers Risk
By Aegis Analytical Corp.
Predictable outcomes lead to greater manufacturing efficiency and speed time to value.
Get This Now »Reducing Tech-Transfer Risk: Collaborative Data Access, Trending, Reporting, and Analytics Span Process Development and Manufacturing
By Aegis Analytical Corp.
When it comes to reducing technology transfer risk, the “secret sauce” is really process understanding. The “desired state” for manufacturing is a design based on a mechanistic understanding that provides real-time quality assurance (rather than expecting quality to be tested in).
Get This Now »Process Excellence: Five Critical Elements of Quality By Design
By Aegis Analytical Corp.
Life-science companies that adopt “quality by design” (QbD) into their overall operations are expected to achieve the “desired state” of manufacturing. So concludes the Q10 document from the EMEA, US FDA, and the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use. The ability to achieve an appropriate quality outcome must be designed into each manufacturing process rather than companies relying on final product testing.
Get This Now »Process Development and Manufacturing Need To Be One Team
By Aegis Analytical Corp.
Justin Neway, CSO of Aegis Analytical discusses pharmaceutical process development, QbD, and manufacturing.
Get This Now »On-demand Data Access and Analytics Enable Decisions for Process Excellence
By Aegis Analytical Corp.
Critical to any PAT effort is having a single point of easy, on-demand access to all relevant data, in a context that’s meaningful to diverse groups of users. But data must be presented in a way that facilitates the identification and understanding of cause-and-effect relationships. Justin Neway, CSO and EVP of Aegis Analytics, talks about the issues and what they mean for PAT-related IT.
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Achieving Manufacturing Process Excellence with Quality by Design, Design Space Development, Design for Manufacturing and PAT
By Aegis Analytical Corp.
Process improvement and Quality by Design become practical realities only when the barriers to easily accessing and working with all the process data together are removed, and the team can spend its time instead on productive science-based collaboration. This is the best way to undertake the Design Space Development, Design for Manufacturing and PAT efforts needed to achieve manufacturing process excellence using the principles of Quality by Design.
Get This Now »How New Technologies Can Improve Compliance in Pharmaceutical and Biotech Manufacturing
By Aegis Analytical Corp.
While U.S. drug products are of high quality, there has been an increasing trend towards manufacturing problems, resulting in recalls, disruption of operations and drug shortages. Companies are missing billions of dollars of potential additional revenue, and necessary medications are sometimes unavailable to the public. By enforcing 21 CFR Part 11 and introducing additional new quality-related initiatives, the FDA is signaling a need for better compliance to ensure consistency and safety. The industry wants to comply, but many manufacturers lack the necessary capabilities, or are unaware that new technologies are available to meet the beefed-up regulatory demands and still operate efficiently and profitably. Justin Neway, Ph.D., executive vice president and chief science officer of Aegis Analytical Corporation examines why these problems occur and how new technology can improve the manufacturing process.
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