CIMdata PLM Industry Summary Online Archive
15 August 2008
Implementation Investments
RTI Biologics Selects Pilgrim Software for Compliance & Quality Management Solutions
Pilgrim Software, Inc., a provider of Enterprise Compliance and Quality Management (ECQM) software solutions, announced that RTI Biologics, Inc., a global provider of sterile biological implants for surgeries, has selected Pilgrim’s integrated SmartAudit™, SmartCAPA™, and SmartComplaints™ modules to drive enterprise-wide productivity improvements and cost reductions.
In February 2008, Regeneration Technologies, Inc. merged with Tutogen Medical, Inc., forming RTI Biologics. The transaction combined RTI’s expertise for science, safety and innovation in biologics for orthopedics with Tutogen’s leadership in sterile biologic implants for dental, hernia and other specialty surgeries. Following the merger, RTI had various manual and paper-based processes for corrective and preventive action, complaints and audit management and sought standardized processes for the entire organization.
The company also was looking to implement stringent and automated audit and CAPA processes to maximize regulatory requirements and minimize risk and enable rapid responsiveness should any compliance or quality issues arise.
“We spent several months evaluating and comparing similar programs. The Pilgrim software modules seemed to have the best functionality, integration capability and work flows by far,” said Karen Norman, RTI’s Executive Director of Quality Assurance. “Although we have just begun our relationship with Pilgrim, the service has been excellent to date and we have high expectations going forward.”
“With a common workflow in place across all its sites and divisions, RTI Biologics looks to maintain ongoing management oversight into quality and compliance issues,” said Prashanth Rajendran, Pilgrim’s Chief Operating Officer. With further improvements to its auditing, CAPA and complaints process efficiencies, the company should sustain a high level of customer satisfaction, further solidifying its reputation as a reliable provider.”
RTI Biologics, Inc. is the leading provider of sterile biological implants for surgeries around the world. RTI prepares human donated tissue and bovine tissue for transplantation through extensive testing and screening, precision shaping and proprietary, validated sterilization processes. These allograft and xenograft implants are used in orthopedic, dental, hernia and other specialty surgeries.
RTI’s worldwide corporate headquarters are located in Alachua, Fla., with international facilities in Neunkirchen, Germany, and Aix-en-Provence, France. The company is accredited by the American Association of Tissue Banks.
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