TAMPA, Fla.--(BUSINESS WIRE)--Pilgrim Quality Solutions, a leading global provider of enterprise quality management software and services for the Life Sciences, today announced the latest release of SmartSolve® Change Management. The solution and its dynamic workflows enforce a consistent process for managing change, helping companies ensure quality by thoroughly evaluating proposed changes, and making informed operational decisions.
Change management is a critical component of Current Good Manufacturing Practices (cGMP). cGMP requires there be a change control system to approve all changes that may have an impact on product quality. Pilgrim’s newly enhanced version of SmartSolve Change Management allows its users to record all types of changes -- from facilities, to equipment, to processes, to documents -- in a single, tightly integrated system.
Standardized workflows allow users to maintain control of changes throughout operational processes, while user-selected attributes dynamically optimize these workflows based on the complexity and urgency of the request. Each change is automatically moved through its required steps, recording different levels of approvals and monitoring implementation activities. This system ensures that the necessary steps have been taken to assess all areas impacted by a change and then tracks the progress and completion of all required activities.
“Organizations in Life Sciences face daily change, be it in formulations, design specs, SOPs, computer systems, or test procedures, and a transparent change control process is essential to maintaining control and making compliance-driven decisions,” said Thierry Durand, Pilgrim’s President & Chief Executive Officer. “SmartSolve Change Management gives you visibility into the status of changes and confidence that they’re being implemented appropriately across the enterprise.”
Change Management is an integrated part of SmartSolve, Pilgrim’s quality management suite of solutions. Integration across the platform ensures that changes resulting from audit findings, defects, and customer complaints, for instance, are addressed using a consistent and compliant workflow. Additionally, Change Management facilitates compliance with IT security standards and regulatory requirements, including FDA 21 CFR Part 11 and EU Annex 11.
About Pilgrim Quality Solutions
Pilgrim Quality Solutions is a leading global provider of enterprise quality management software and services for the Life Sciences and other highly regulated industries. For more than 20 years, our solutions have automated thousands of processes that ensure the quality of life’s most important products. Product quality and patient safety increase while risks decline. Our on-premise and cloud technologies reflect quality industry standards and include electronic signatures, audit trails and validation packs - helping customers more easily achieve compliance and pass regulatory audits. With Pilgrim Quality Solutions as your partner, you are prepared to succeed. For more information, visit www.pilgrimquality.com.