Software for SAP Integration Links Quality Management and Control Workflows
21 Nov 2014The culmination of drug manufacturing is delivery of the final product to the customer, and the main goal of this process is to expedite product delivery and meet production timelines while ensuring that the active pharmaceutical ingredient and final formulation meet clearly defined specifications. This white paper from waters demonstrates how the NuGenesis® 8 platform easily and effectively bridges the gap between the scientists in the quality control laboratory who are performing analytical batch testing in advance of product release and the quality control managers, which need to convey instructions clearly and quickly to the QC team on lots to be evaluated, testes to be performed, specifications to be met, and data and reports required for product validation. The benefits of SAP integration are also presented in this paper.
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NuGenesis 8 Featuring LE Technologies
WatersWaters NuGenesis 8 featuring LE (Laboratory Execution) Technologies is a comprehensive data management and workflow solution that supports the entire product lifecycle from discovery through manufacturing. This user-centric platform encompasses NuGenesis SDMS, a compliant-ready data repository, and NuGenesis ELN, a flexible analytical electronic laboratory notebook. NuGenesis 8 provides a synergy of information management technologies unlike anything available in the market today. Capabilities such as sample management, laboratory inventories, data retention and legal hold, and electronic laboratory execution methods, allow NuGenesis 8 to connect the scientific data from your laboratories to the business systems of your organization more effectively than ever before.
NuGenesis® SDMS
WatersApplication Independent Electronic Information Management The NuGenesis® Scientific Data Management System (SDMS) is an automated electronic repository that stores and manages all types of scientific data to a centralized database, offering excellent integration with a multitude of research applications. Accelerate Research and Development Scientists at leading pharmaceutical, biotechnology and chemical/industrial companies have standardized on SDMS because it: Accelerates research Improves scientific collaboration Preserves data for the long term Provides documentation and protection for intellectual property and 21 CFR Part 11 compliance Using automated “file and print capture” technology, SDMS captures and stores the critical scientific data generated by any instrument or application. All data is automatically made searchable using advanced functionality. Locate and Repurpose Information With SDMS you can find and repurpose information, from reports to chemical structures, with traceable, hyperlinked access to the source data that generated that information. Robust tools allow you to export that information to business applications and share it with collaborators anywhere in the world. Together with Vision Publisher combining and documenting information to author scientific reports has never been easier. Exchange Data with Common Enterprise Systems NuGenesis SDMS exchanges data with electronic laboratory notebooks (ELNs), LIMS, EDMS and other common enterprise technology systems. It seamlessly integrates with your existing IT infrastructure, scales to the enterprise, provides data security, offers central or distributed administration and can be quickly deployed.