Foster Delivery Science Implements AssurX Quality Management and Regulatory Compliance Software
AssurX Platform Automates Document Management and Training Management; More Processes Planned
MORGAN HILL, CA, UNITED STATES, February 03, 2021 — AssurX, Inc. (AssurX), a leader in quality management and regulatory compliance software, announced today that Foster Delivery Science, a leader in biomedical polymers, has selected the AssurX platform to automate their quality and compliance management processes.
Foster Delivery Science is a division of Foster Corporation, a leader in custom blending and extrusion of biomedical polymers and additives. Foster Delivery Science leverages its expertise in melt extrusion to serve the unique needs of the pharmaceutical industry with polymer and process technology for drug delivery applications. Foster Delivery Science operates a 32,000 square foot cGMP manufacturing facility in Putnam, CT.
Foster Delivery Science implemented AssurX’s electronic quality management software (EQMS) for document management and training management to align with ISO 13485 and 21 CFR part 210 and 211 cGMP requirements for pharmaceutical manufacturers. Prior to that, Foster Delivery Science was utilizing a shared quality system. “The documentation existed,” explained David Vario, Vice President of Quality and Regulatory at Foster Delivery Science, “however, our specialized manufacturing processes and sharp focus on organizational compliance require a system built to align with FDA pharmaceutical and medical device regulations.”
The AssurX platform was evaluated by all business areas prior to selection. “Management, IT, QA, Operations and Document Management unanimously agreed that AssurX met our needs for a configurable system that could meet the rigors of validation, efficient import and indexing of documents, strong process functionality, and secure access requirements,” explained Vario.
“AssurX is pleased to have Foster Delivery Sciences as a customer,” said Tamar June, President, and CEO of AssurX, Inc. “Many of our customers lead their implementations with document management and training management due to the importance of document control as it relates to the delivery of all quality processes. While there is some heavy lifting up-front in terms of the initial document import, AssurX provides all the tools and support necessary for ease of presorting, indexing, and storing documents in a secure, centralized repository.”
Foster Delivery Science is now managing standardized document control and training to further improve operations for the division. “Our users found it very easy to acclimate to the AssurX system and we used their input to design our dashboards in a way that was most useful for them,” added Vario.
Foster Delivery Science plans to implement additional quality processes into their AssurX system including calibrations and preventive maintenance, change control, supplier management/auditing, deviations and investigations, and CAPA.
ABOUT FOSTER DELIVERY SCIENCE
Foster Delivery Science is a business unit of Foster Corporation. Foster Corporation was founded in 1989 to serve the specialty polymer requirements of newly emerging medical device companies. Since its inception, Foster has become a leader in custom blending and extrusion of biomedical polymers and additives. Today Foster operates out of a 47,000 square foot facility in Putnam, CT, which serves as the company headquarters, a 20,000 square foot plant in Las Vegas, NV, as well as a new 32,000 square foot cGMP manufacturing facility operated by Foster Delivery Science, also located in Putnam, CT. For more information, please visit www.deliveryscience.com or www.fostercomp.com.
ABOUT ASSURX INC.
With decades of expertise built into our quality management and regulatory compliance software, the AssurX Quality Management Software Platform helps companies maintain quality and compliance standards, streamline workflow and better manage any enterprise. Our configurable software and understanding of users’ needs produce a unique system that easily adapts as a customer’s business evolves. AssurX is an ideal partner for regulated companies looking for better operational control and efficiency while staying compliant. To learn more, visit www.assurx.com.