Pilgrim Achieves ISO 9001:2015 Quality Management System Certification
Tampa, FL -- March 8, 2018 -- Pilgrim Quality Solutions, an IQVIA company, has been certified as ISO 9001:2015-compliant after an extensive audit of the company’s internal operations. This ISO 9001:2015 Quality Management System (QMS) certification demonstrates Pilgrim’s compliance with strict quality management principles within its software development processes.
The ISO (International Organization for Standardization) standards for quality management systems (QMS) serve as the basis for the Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP) required by most government regulatory bodies.
Life Sciences organizations develop life-saving products including medical devices, pharmaceuticals, and biologics that need to have consistent, high-quality performance and meet stringent industry regulations. Pilgrim incorporates ISO quality management process standards into its enterprise QMS (eQMS) software development to mirror this commitment to high quality and regulatory compliance.
“Achieving ISO 9001:2015 certification spotlights Pilgrim’s structured and systematic approach to software development,” said Rick Lowrey, Pilgrim’s General Manager. “For more than 20 years, Pilgrim has been designing software solutions that reflect the best practices outlined in ISO quality standards, and implementing those solutions into clients’ organizations. Our customers, numbering in the hundreds, understand the value quality compliance, and have chosen to dedicate resources to proactively managing it with our solutions. This achievement attests to Pilgrim’s fundamental and continuous commitment to quality.”
Pilgrim leverages its commercially available eQMS platform, SmartSolve®, to automate key elements of its own corporate quality management program. SmartSolve streamlines numerous quality management processes, including those for managing audits, CAPAs, complaints, nonconformities, inspections, suppliers, changes, documents, and training certifications.
IMS International, an internationally accredited certification body, audited the quality management system at Pilgrim and certified Pilgrim Quality Solutions in accordance with ISO 9001:2015. The official certificate can be viewed here.