KBI Biopharma selects The Windshire Group's and Simplyfeye's ProcessPad(TM) continued process verification solution
(firmenpresse) - BOSTON, MA -- (Marketwired) -- 05/24/17 -- The Windshire Group, LLC and Simplyfeye Inc. are pleased to announce KBI Biopharma, Inc. will deploy ProcessPadtm for its data analysis, management and reporting solution for process development, product scale-up and commercial manufacturing operations. KBI is a leading CDMO (contract development and manufacturing organization) and has served over 250 clients worldwide, including most of the top ten pharmaceutical companies.
"We were impressed with ProcessPad's potential to help us [KBI Biopharma] capture, organize and provide easy access to comprehensive process information for process monitoring, reporting, and analysis during process development, scale-up and commercial manufacturing. This new capability will also benefit our customers," said KBI's VP of Manufacturing, Dr. Carnley Norman.
"We appreciated KBI's desire to continuously improve for their customers and their thorough review of ProcessPad's competitive space. They recognized the ability of ProcessPad to enhance their capabilities and streamline their internal business processes to better meet customer expectations. We are seeing strong interest in ProcessPad from the CMO segment for both small and large molecules," stated Dr. James Blackwell, President of The Windshire Group.
ProcessPad is the (bio)pharmaceutical industry's leading 21 CFR Part 11 compliant continued process verification solution for integrating quality, process and manufacturing data for monitoring, visualization, trending, reporting and analysis. ProcessPad uses a browser interface to provide easy, on-demand data access across organizational functions and sites. ProcessPad can be hosted by customers' internal IT environment or within Windshire's secure ARCC (Audit Ready Compliant Cloud) offering.
Organizations benefit from more efficient use of human resources; process improvements and higher manufacturing yields; more robust investigations and troubleshooting; higher quality and enhanced compliance.
"ProcessPad is useful for all organizations, from small development companies to large multi-nationals, and for all stages of the product lifecycle, from early process development through commercial manufacturing. ProcessPad also helps organizations meet regulatory expectations for continued process verification, trend monitoring, and data integrity," said Anshuman Bansal, CEO of Simplyfeye.
The Windshire Group's CMC (Chemistry Manufacturing Controls) and management consultants serve (bio)pharmaceutical clients globally by providing technical, regulatory, quality, operational and strategic expertise that speeds commercialization, and enhances compliance and operational efficiencies. In synergy with Windshire's consulting practice, Windshire also offers data analysis, quality system solutions and related services -- Stabilityshire(SM) (stability/shelf life consulting and analysis), Trainingshiresm (training services), Assurashiresm (augmented quality personnel support), RegDocs365 (quality management system (QMS) solutions), and ARCC (Audit Ready Compliant Cloud). Windshire also supports investors by providing technical and strategic evaluations of new products and technologies, and assisting with development and commercialization plans of potential investments or existing portfolio companies. To learn more about ProcessPad or our other products and services, visit windshire.com, or contact the company at (+1) 844.686.5750 or . Folllow us on LinkedIn at and Twitter at #TheWindshireGrp.
Simplyfeye provides data analytic products and solutions to life science processing companies. Its ProcessPad software enables these organizations to maximize the value of their quality metric, process, QC and manufacturing data throughout the product lifecycle. Simplyfeye is partnered with The Windshire Group, LLC for marketing and servicing ProcessPad in the Americas. To learn more, please visit or contact the company at .
The Windshire Group, LLC
James Blackwell, Ph.D.
(+1) 844-686-5750
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Datum: 24.05.2017 - 16:33 Uhr
Sprache: Deutsch
News-ID 544425
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Biotech
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