See Press Release Note

Building on Lonza’s extensive informatics know-how and contract manufacturing expertise, the new platform offers a flexible and user-friendly solution for consolidating and managing batch and quality data generated by non-automated manufacturing processes.

The MODA-ES™ Software Platform has been designed to provide a cost-effective solution to batch record challenges.

Electronic batch records have been unattainable for most of the industry due to cost constraints and flexibility concerns. Lonza is changing that with the launch of the MODA-ES™ Platform, which facilitates paperless execution across manufacturing and QC processes. The MODA-ES™Platformequals One Record, One Platform to move companies into the digital age and allow them to reap the benefits of efficiency, improved compliance, real-time reporting and expedited release of products to customers.

“The MODA-ES™ Electronic Batch Record Execution Platform builds on Lonza’s unique manufacturing, quality- control and informatics expertise to bring a cost-effective, flexible and scalable solution to the market,” said Mike Goetter, General Manager, Informatics, Lonza Pharma & Biotech – Bioscience Solutions. “This platform will enable manufacturing organizations to rapidly scale to a paperless workflow and empower them to make informed decisions while improving efficiency and compliance.”

Introducing a different approach to informatics in life-science manufacturing

Attendees of the Paperless Lab Academy can learn more about the key features and benefits of Lonza’s new MODA-ES™, including:

• Workflow-driven data entry applicable to batch records, sterility tests and cleaning forms
• A modular design allowing individual modules to be created, validated and used across different processes
• Standard methods for processing products of the same family, with the flexibility to vary the raw materials, fill volumes and equipment types used
• An electronic checklist enabling real-time review and approval
• Data integrity alert capability to trigger timely intervention and resolution of issues
• Seamless integration with other cGMP compliant electronic systems, as well as with analytical equipment, for effortless, reliable data transfer

For additional information or to request a demonstration, visit www.lonza.com/moda-es.

Lonza is present at the Paperless Lab Academy 2019 as Premium Sponsor and will hold a workshop about “Practical applications of Data Integrity and Audit Trail Review” 

The post [PressRelease] Lonza to Launch the MODA-ES at the Paperless Lab Academy 2019 appeared first on .

Lonza’s MODA-EM™ Version 3.3 software enables microbiology Quality Control (QC) laboratories to comply with new regulatory
guidelines.

QC facilities have to manage the daily challenges of QC monitoring while meeting changing regulatory compliance mandates. Lonza’s latest software release meets these evolving challenges with additional features focusing on data integrity, data visibility and data review.

MODA™ Version 3.3 delivers improved workflow with better analytics and reporting than ever before. Complete with a streamlined implementation and a risk-based validation solution, this software is the paperless solution for QC laboratories.

“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 has been designed to meet end user requirements and features enhanced scheduling and calendar capabilities for simplified sample management. It also offers web-based dashboards so that metrics and results can be accessed from anywhere with an internet connection. Scientists in QC laboratories are also supported with a validation documentation package that meets current industry standards and regulatory requirements, with execution and pre-validated service options available.

Within the Life Sciences industry, paper-based QC Micro laboratory processes can be expensive, error-prone, time and labor-intensive.

MODA™ Paperless QC Micro Solution

With the MODA™ Solution, organizations can automate quality control processes for regulated manufacturing and quickly advance their Green initiatives.

By combining automated scheduling, workflows, mobile data acquisition, device integration, and advanced analytics, the MODA™ Solution delivers efficiencies across your organization.

1. Gain complete insight into your manufacturing operations
2. Quickly access reports and trends on your quality data – at the click of a button

The MODA™ Solution encompasses automation of the full spectrum of QC activities including environmental monitoring (EM), utility testing, and product testing. MODA™ Software easily integrates with commonly used instrumentation and media found in manufacturing facilities, specifically production and laboratory areas. Organizations gain timely and accurate QC monitoring by utilizing location-based scheduling, mobile data collection, and paperless lab processing. MODA™ Software also delivers on-demand reporting, trending, and visualization capabilities to allow in-depth process analysis and ad hoc queries by decision makers.

The MODA™ Solution integrates with Laboratory Information Management Systems (LIMS) to bridge the communication gap between QC and production.

Components Include:

MODA-EM^® — Lonza’s flagship software for paperless EM automates your QC Micro data collection and management (EM, utility, and product testing).

MODA-VIP^® — Visual Intelligence Portal provides improved insight into your manufacturing operation and testing data.

MODA-FDC^® — Field Data Capture lets you quickly collect, label (barcode) and track test samples for EM, utilities, and products at points of sampling within all critical areas.

The post Lonza released its latest MODA™ Software Version appeared first on .