“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.
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 Audit Ready Compliant Cloud (ARCC).
Organizations benefit from more efficient use of human resources; process improvements and higher manufacturing yields; more robust investigations and troubleshooting; higher quality; and better regulatory compliance.
“We were impressed with 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 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 and trend monitoring” 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. Their consultants are located throughout North America and Eurasia. In synergy with Windshire’s consulting practice, Windshire also offers industry leading data analysis and quality system solutions and related services- ProcessPad, StabilityshireSM (stability/shelf life data), Informashiresm (virtual digital information services), RegDocs365 (QMS solutions), and ARCC (audit ready compliant cloud). To learn more about ProcessPad or other products and services, visit www.windshire.com, or contact the company at (+1) 844.686.5750 or [email protected].
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. In India, ProcessPad is being used by leading biotechnology, pharmaceutical and vaccine manufacturing companies like Dr Reddys Laboratories, Intas Pharmaceuticals, Zydus Cadila. Simplyfeye is partnered with The Windshire Group, LLC for marketing and servicing ProcessPad in the Americas. To learn more visit www.simplyfeye.com or contact the company at [email protected]