Ricerca Biosciences, LLC recently made the transition from paper to an electronic quality management system by implementing Xybion’s Labwise product. This resulted in lower organizational risk and increased client confidence, allowing the company to focus on its core contract research service business.
The Challenge Ricerca Faced
Founded in 1986, Ricerca Biosciences, LLC collaborates with pharmaceutical developers by providing a comprehensive, integrated suite of services to accelerate drug development. Ricerca, a US-based nonclinical CRO, faced inefficiencies in managing its various regulated documents due to a highly manual, paper-based quality management system. The Quality Assurance department needed to find a way to respond to client audits and regulatory authorities more quickly. This required moving to an electronic quality management system. In addition, numerous process deviation types were in scope and needed to be addressed, preferably in one system.
Enter Labwise from Xybion
Xybion’s Labwise product was implemented in North America for the management and control of numerous policies, procedures, work instructions, and other documentation in a consistent manner. A well-structured folder system and permissions scheme was put in place, enabling users to find documents quickly. The configuration included PDF rendering and stamping configurations.
In addition, using Labwise’s flexible process designer, numerous types of deviations were tracked, including process and lab deviations as well as Corrective and Preventive Actions (CAPAs). These critical workflows were used across departments to cover an array of specialized deviation tracking needs.
“We were able to configure our own process designs, including some specialized plug-in reports – a testament to the ease of configuring Xybion’s Labwise platform. This allowed us to minimize ongoing maintenance costs.” -Stephen Rogenthien, Director of Quality Assurance
Benefits to Ricerca from implementing Labwise
- Control and automated reporting over thousands of critical documents required by regulatory authorities, resulting in reduced risk.
- Multiple deviation types tracked in one system, resulting in lower IT costs.
- The flexibility of the Labwise platform enabled Ricerca to configure, migrate, and train on the system using in-house resources, supporting a lower TCO.
Labwise is a unique, comprehensive solution for Quality, Governance, Risk and Compliance designed for GLP laboratory environments. It can be used as a stand-alone laboratory compliance system or integrated with Pristima, the industry standard for total preclinical data management. Labwise consolidates the functionality normally found in disparate systems, such as LIMS, Quality Management, Document Management, and BPM tools in one platform. Converging on the Labwise platform lowers your total cost of ownership, reduces your IT infrastructure complexity, and streamlines cross-department collaboration.
Download the Labwise Brochure