Quality systems for EdgeTRAC™ software verified to meet the requirements of customers who are regulated under the U.S. Code of Federal Regulations (CFR) Title 21
Pittsford, NY – Feb. 26, 2015 – ROC IT Solutions, supplier of software that enables track and trace in the pharmaceutical supply chain, successfully completed an independent audit of its quality systems for a North American pharmaceutical company regulated under the Code of Federal Regulations (CFR) Title 21.
The audit was completed by Coda Corp USA (www.codacorpusa.com), a leading provider of quality system services to regulated companies in the pharmaceutical, biopharmaceutical, and medical device industries. It was ROC IT Solutions’ third successful audit in 2014 for regulated customers and certified partners.
“ROC IT Solutions is an extremely well-informed and process-oriented team,” said Gina Guido-Redden, COO of Coda Corp USA. “I have hardly ever been to a small software firm and had so little to tell them.”
Companies regulated under CFR Title 21 are required to assess and evaluate the suitability of all vendors of goods, services and products that they use. The on-site audit assessed the quality practices and systems used at ROC IT Solutions to ensure the reliability of the ROC IT EdgeTRAC™ software that is delivered to the client.
ROC IT’s quality systems were evaluated for robustness in all product stages, from building solution requirements through verifying the effectiveness of the software solution in the field. The stages are:
- Plan and Develop – encompassing the software development life cycle (SDLC) including coding and testing
- Integrate and Implement – encompassing solution configuration for the client as detailed in ROC IT’s Rapid Value Process (RVP)
- Measure, Monitor and Improve – customer relationship management including customer feedback and issue investigation throughout solution integration and implementation
- Verify Effectiveness – monitoring solution performance in the field, including client feedback and change management
“At ROC IT Solutions we’re process-oriented by nature, and going through this audit with Coda Corp USA — sharing their passion about the topic — reminds us why,” said Larry Hall, VP of Operations and Quality Officer at ROC IT. “Our focus on process to ensure quality and continual improvement is a win-win for us and for our clients in this highly-regulated industry.”
About ROC IT Solutions
ROC IT Solutions enables serialized data capture, label printing and tag management for receiving, picking, shipping, returns, deactivation, aggregation and de-aggregation of pharmaceutical products. Our solutions streamline serialization at all points in the supply chain, from manufacturers to wholesalers, distributors and retailers. Through more accurate and efficient supply chain serialization, ROC IT Solutions’ track and trace software helps companies protect revenues, combat counterfeiting and diversion, and ensure consumer safety.
ROC IT serialization software enables “intelligent edge data capture,” allowing companies to capture and process data for serialized assets at the edge of the supply chain, where materials handling takes place. By reducing data capture errors and providing real-time decision making at the point of materials handling, our solutions enable serialized product tracking without bottlenecks or bandwidth issues. Our unique distributed architecture enables agile and scalable solutions that are easily deployed and maintained to support any ERP, EPCIS / Serial Number Management, track-and-trace, Auto-ID or other application, as well as interoperability with any device for barcode and RFID data capture, using GS1 standards. Learn more at http://www.rocitsolutions.com.