cGMP Informatics
" cGMP Informatics - A Three-Tier IT Infrastructure Approach: ERP, "thin-LIMS", and a lab execution layer with a GMP Electronic Notebook System"
A significant objective of the new current Good Manufacturing Practices (cGMPs) initiative, Six Sigma, Lean Manufacturing, and Process Analytical Technologies (PATs) is encouraging the adoption of new technological advances to enable compliant, high quality and efficient manufacturing and distribution of pharmaceutical products.
Pharmaceutical quality operations have not changed its fundamental paper-based data management infrastructure in decades. Recently, industry and the FDA have become very aligned with respect to utilizing innovation and technology to bring manufacturing processes into the 21st century. Leading companies are adopting a new approach to "automating compliance" by utilizing innovative technologies and building quality into the compliance infrastructure (SOP's, work instructions, analytical methods, data sheets, batch records and more).
Many of these internal programs are sometimes called "Right-First-Time" or "Operational Excellence" programs. Their key conclusion is that compliance activities can be automated, creating a new more productive work environment, reducing compliance risks and providing higher overall productivity. Automation enables companies to institutionalize these new initiatives on a global basis.
This web seminar will discuss the current situation in manufacturing and quality operations relative to industry compliance initiatives and manufacturing challenges. It profiles an innovative "method/SOP-centric" software platform, designed for the analyst/operator, to electronically execute and manage QC testing protocols, stability testing and production batch records, yielding significant reductions in overall product release cycle times and costs. This platform fits within a novel three-tier compliance IT architecture to enable quality operations to go paperless and provided automated data flow from the lab bench to product release.
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