CoreRx® has moved to ensure it surpasses the rigorous compliance demands of both the regulators and its own partners by investing in an electronic quality management system (EQMS). With rapid expansion on the horizon, the drug product development and manufacturing specialist made the decision to invest in upgrading its paper-based document management system in 2013 using X-docs™ from Formpipe Life Science. This decision ensured it could continue to efficiently deliver outstanding services to its regulated pharmaceutical clients of all sizes. Now, less than 18 months later, CoreRx® is again calling on Formpipe to enhance the efficiency of its EQMS, this time with the addition of CAPA/deviation management and training modules, X-forms™ and X-train™ respectively.
At the start of 2013 CoreRx® had approximately thirty staff members based in one facility in Clearwater, Florida. At that time it relied fully on a paper-based Quality system to create, file and archive their documents, a process critical to the company maintaining a state of control of its manufacturing processes and staying compliant in the eyes of the Food and Drug Administration (FDA). With an increasing number of new contracts resulting in more regular audits from potential and existing customers, an increased number of client-specific documents to manage, and practical concerns over storage and retrieval, CoreRx® decided to safeguard its future and fully digitize its document management function.
In 2015 the decision to invest in efficiency has paid off. CoreRx® is now more than twice the size it was less than a year and a half ago in terms of employees and locations, with plans for a third facility to come online in the near future. These new resources contribute to creating and maintaining over 230
standard operating procedures (SOPs), 150 test methods, and numerous batch records and equipment manuals, all of which are all now effectively and efficiently managed in X-docs™.
CoreRx’s® Director of Quality Assurance Kyle Brinkman has been impressed with how X-docs™ has worked to simplify and speed up the task of staying compliant, as he explains: “With our paper-based system, we were spending virtually all our time supporting client and regulatory audits. With our growth projections, we knew we couldn’t continue with the status quo – we needed to go electronic. We have been very pleased with our decision to implement the X-docs™ platform to manage all of the documents, test methods and standard operating procedures used here at CoreRx®. We’re a very customer-focused organization, so the ability to bring in our clients or the regulators and give them full audit access to our document management system with complete confidence they will easily find what they are looking for is great for me from a quality assurance point of view, and great for them as it demonstrates both regulatory compliance, transparency and efficiency.”
“Document management is a requirement for every regulated pharmaceutical organization. But as we operate in one of the most tightly regulated industries there is, it was fantastic to have a partner in Formpipe that really understood the unique challenges we face. The increase in growth over the past few years has been tremendous, and X-docs™ has made it simpler to maintain records, stay compliant, and reduce the untold staff-hours we were losing through the inefficiency of the old paper system. We’ve progressed a long way in partnership with Formpipe Life Science, and without X-docs™ I don’t think we would have been able to achieve the growth we’ve had. I look forward to adding X-forms™ and X-train™ to complete our EQMS portfolio.”
Work is now well underway to implement the X-forms™ and X-train™ modules that will once again enhance the efficiency of CoreRx® quality systems and processes, with full roll-out due to complete in the third quarter of 2015. The project continues to excite all at Formpipe Life Science, as its Managing Director Keith Williams confirms:
“The X-docs™ platform is very adaptable and quick to deploy, and it is extremely scalable to support our clients as they grow. Staying Compliant is an absolute necessity for our Clients, but so is growing their business. Adding X-forms™ and X-train™ will give CoreRx® a more complete quality system, and
allow them to focus on meeting and beating their business goals and demonstrating continuous Quality improvement.”
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About CoreRx®, Inc.
CoreRx® offers comprehensive drug product development services to the pharmaceutical and biotechnology industries. Supporting virtual, mid-size, and multinational companies, CoreRx® offers customized formulation development & clinical material manufacturing solutions. Our solutions maximize client investments, shorten development time, and reduce overall costs. From First-in-Man drug development, to full CMC support, CoreRx® combines 200+ years of pharmaceutical development experience and expertise to produce safe, effective, and innovative drug products, on time, and on budget.
About Formpipe
The Formpipe Life Science division simplifies complex process and technology environments to deliver customers’ quality and compliance goals within their relevant regulatory framework. This is achieved through a combination of Consultancy to ‘Get Compliant’, and Products and Consultancy to ‘Stay Compliant’, which are delivered by experts from the sector. A suite of products, which are designed to be easy to use, to increase efficiency and reduce costs, addresses the compliance and quality needs of Life Science organizations with up to 25,000 users. All Life Science products are managed using an internal Quality Management System, which is maintained by a dedicated global team that is simply compliant.
Formpipe Life Science is a global organization, based in Nottingham, England with offices and people in the UK, USA, Netherlands, Sweden, Denmark, and Ukraine.
Parent company Formpipe Software AB develops Enterprise Content Management (ECM) products and solutions for structuring information and supplies them to major companies, authorities and organizations. ECM products help organizations to capture, manage and distribute information, and to place it in context. The company’s software helps improve efficiency, cut costs and reduce risk exposure. Formpipe was founded in 2004 and has offices in Stockholm, Uppsala and Linköping in Sweden, and in Copenhagen, Denmark. Formpipe is listed on NASDAQ OMX Nordic.
Press contacts
For further information or images please contact;
Sally Vernon, Marketing Manager at Formpipe
Sally.vernon@formpipe.com
t: +44 (0)115 924 8475
Mark DaFonseca, Executive Director at CoreRx®, Inc.
mark.dafonseca@corerxpharma.com
t: (727) 259-6950
