Software Assists With Regulation Compliance
Osmetech Molecular Diagnostics, Roswell, Ga., (osmetech.com), a manufacturer of diagnostic equipment, purchased SmartCAPA, SmartComplaints, and SmartDoc software modules from Pilgrim Software Inc., Tampa, Fla., (pilgrimsoftware.com). The software will let the equipment manufacturer upgrade its quality management system and help build on its success with its recently developed cystic fibrosis carrier-detection test and a DNA detection instrument.
The software streamlines business processes. SmartCAPA and SmartComplaints, for example, form a CAPA and complaint-management system that lets users report, react, and resolve issues, thus preventing recurrences. SmartDoc creates, manages, and accesses critical documents as well as enforcing enterprise-wide procedures. “The software lets us take a proactive approach to risk management by ensuring regulatory issues and customer complaints are reduced or avoided upon launching new products,” says Osmetech VP Robert Dicheck.
“Pilgrim software runs almost out-of-the-box,” says Pilgrim COO Prashanth Rajendran. The scalable software also lets them add modules and users when necessary.
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