TAMPA, Fla.--(BUSINESS WIRE)--Pilgrim Quality Solutions, a leading global provider of enterprise quality management software (QMS) and services for the Life Sciences, today announced the introduction of its latest versions of key solutions within its SmartSolve® platform. These solutions include enhancements that expand the already robust SmartSolve compliance with ISO 13485:2016 regulations. In an industry first, Pilgrim has launched these enhanced solutions to prepare life sciences organizations to meet the requirements of the latest standard, including expanded risk management and supplier management, along with other regulatory capabilities, such as MDSAP, prior to global enforcement in early 2019.
Processes impacted by the regulatory changes and risk considerations include audits, incoming inspections, nonconformances, corrective and preventive actions (CAPA), customer complaints, change control, document control, and training. For each process, Pilgrim has added additional capabilities to its solutions.
“It is critical that risk-based thinking be embedded across respective quality and compliance activities,” said Rick Lowrey, Pilgrim’s Chief Executive Officer. “The ISO13485:2016 regulations will drive the industry to this paradigm. All QMS processes require a risk-based approach, not simply a standalone risk management process.”
Pilgrim’s SmartSolve solutions provide quality processes that direct the level and flow of activities based on the risk assessment, enabling Pilgrim customers to automatically leverage risk-based thinking in the quality processes they manage every day.
“Pilgrim, while working directly with our Customer Regulatory Advisory Board, aims to ensure timely delivery of solutions in preparation for the compliance deadline in 2019,” added Lowrey.
By example, Pilgrim SmartSolve Audit Management has been enhanced to further support Quality Audits by tying auditee risk to supplier rating as a part of the audit planning process to drive audit frequency and rigor. The latest version of Supplier Quality Management automates sampling plans and inspection frequency for incoming material inspections based on supplier rating and risk. The enhanced Nonconformance Management and Complaint Management solutions provide risk analysis tools to ensure that CAPAs are created and prioritized for high-risk quality events. Change Management now allows its business process workflow to be dynamically managed based on the risk of each proposed change. Enhanced Document Management and Training Management provide organizational oversight to safeguard against insufficiently trained personnel.
Additional Management solution enhancements address the shifting focus within the quality and regulatory segments of the Life Sciences toward the value of focusing on quality versus compliance, as well as increased emphasis on the performance, usability, and security of quality management solutions.
“Supporting ISO 13485:2016 compliance is the top priority throughout the industry right now,” Lowrey said. “The time is now for all life sciences companies to ensure they are prepared to address these key changes, and that’s why we are launching our enhanced solutions at this time. We’re committed to our customers’ success in upgrading or implementing our latest version of our solutions to help them address the new standards,” Lowrey said.
Pilgrim Quality Solutions is the leader in quality compliance management software and services for Life Sciences. For more than 20 years, our solutions have automated thousands of processes across global company sites to manage the quality and compliance of life’s most important products. Our cloud-based and on-premise solutions include in-the-box best practice workflows, document and process management, dashboards, electronic signatures, audit trails, and automated validation – helping companies more easily achieve quality system compliance and pass regulatory audits. Pilgrim Quality Solutions is majority owned by Boston-based private equity firm, Riverside Partners LLC. With Pilgrim Quality Solutions as your partner, you are prepared to succeed. For more information, visit www.pilgrimquality.com.