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DIGITAL SOLUTIONS DESIGNED TO MANAGE COMPLEXITY

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Knowledge Management
Technology Transfer
Integrated Quality Management
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Knowledge Management

The pharma and biotech industries are beginning to move forward with a commitment to digital transformation to improve their overall productivity.  While the path is often clear for discovery (at the very beginning) and commercial manufacturing activities (at the very end), the lack of an integrated and structured software solution to manage the process development and manufacturing activities in between has been a significant challenge.

QbDVision meets this challenge by providing a structured framework for knowledge management that allows organizations to drive process understanding and intelligence while automating compliance with regulatory requirements.  The best practices and workflows enabled by QbDVision create a flexible environment where requirements, risk, data, and analytics all come together to inform process development activities in real-time akin to agile development methodologies.

Technology Transfer

The transfer of technology and related information from one organization to another or from one site to another is one of the biggest challenges still facing the pharma/biotech industry.  As these industries look to respond faster with the development of therapies and vaccines, this segment of the product lifecycle needs urgent attention. 

One of the major hurdles to efficient technology transfer has been the lack of structured information describing the accumulated manufacturing process development activities. Information is often shared as files, documents, etc. requiring dedicated project management teams to assemble information, perform gap analyses, and translate between business and scientific requirements all before any technical work can even begin.  

QbDVision's knowledge management framework changes all of that.  With process development knowledge recorded in a highly structured environment, the tasks of technology transfer become radically simpler and a lot faster. 

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Integrated Quality Management

Does good quality compliance guarantee good product quality? Not necessarily.  In fact, the increase in manufacturing and product quality issues while quality management systems are becoming more elaborate would indicate that something is missing.  We believe that what is missing is the integration of knowledge management with quality management.  How often does your technical team need to review more detailed justifications of specifications or control strategies only to find that these are buried in some report in your QMS system which cannot easily be linked to your spreadsheet?  We believe that product quality and quality compliance need to be together in the same environment to realize the true efficiencies of digital transformation. 

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ABOUT

CherryCircle Software, Inc.

2101 E. St. Elmo Road 

Building 1, Suite 100

Austin, TX, 78744

info@qbdvision.com

© 2017-2021 CherryCircle Software

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