NuGenesis ELN

Improve Laboratory Efficiency for Free-Flow Documentation

NuGenesis ELN allows scientific documents to be easily created from predefined templates, making it easy to adapt to the existing workflows in your lab – you can easily add selected content to these documents by interactively or automatically extracting information from NuGenesis SDMS, Empower, MassLynx, or other applications.

• Includes messaging, project and team organization, document review features, customizable reporting capabilities, and a powerful search engine
• Existing documents such as Microsoft Word, Excel, and Adobe PDFs can be dragged-and-dropped into NuGenesis ELN
• Built-in inventories for instruments and reagents

Facilitate Process Driven SOP Method Execution

The NuGenesis Lab Management System provides a workflow software package designed to guide the laboratory analyst through a routine, comprehensive standard operating procedure (SOP). Key features include:

• Supports your workflow with optional document-integrated business logic functionality, including pre-formatted laboratory execution methods for common pharmaceutical QC tests such as identity, assay, dissolution, and content uniformity
• Configurable to enforce prescribed workflows
• Certified interface to SAP-QM
• Interfaces with LIMS and instrument/chromatography data systems, such as Empower and MassLynx Software
• Laboratory inventories capability ensures analysts use only valid/calibrated instruments and consumables throughout a given analysis.
• Provides comprehensive sample management and tracking capabilities

Security, Evidence Protection, and Compliance

The NuGenesis Lab Management System is designed to be compliance-ready and has a Certificate of Structural Integrity to support users in a regulated environment. It also enables you to meet cGxPs, EU GMPs, and other regulatory requirements worldwide for users of this product. NuGenesis also allows you to be compliance-ready for 21 CFR Part 11, and the U.S. FDA’s Electronic Records and Signature Rule. In addition to providing regulatory safeguards, NuGenesis ELN ensures the authenticity of electronic records and it is certified to support the SAFE-BioPharma digital identity and signature standard.