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Updated to allow companies to meet changing QC regulatory guidance
October 25, 2017
By: Kristin Brooks
Managing Editor, Contract Pharma
Lonza has released MODA-EM Version 3.3 software designed to enable microbiology Quality Control (QC) labs to comply with new regulatory guidelines. This latest software release aims to address evolving challenges of QC monitoring and meeting changing regulatory compliance with additional features focusing on data integrity, data visibility and data review. MODA Version 3.3 is designed to improve workflow with better analytics and reporting. It includes a streamlined implementation and a risk-based validation solution, offering a paperless option for QC labs. “It is essential for QC laboratories to be able to readily adapt to changing regulatory guidance. To aid this compliance MODA Version 3.3 features a new, fully searchable audit trail that lets scientists easily track changes made through a sample’s lifecycle,” said Sinéad Cowman, EU business development manager for Lonza Informatics. “The paperless efficiency features save time on many everyday activities, such as settling plate exposure times, organism identification and master data management and review.” The new software features enhanced scheduling and calendar capabilities, web-based dashboards with accessible metrics and results, and is supported with a validation documentation package that meets current industry standards and regulatory requirements. Also, execution and pre-validated service options are available.
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