NuGenesis ELN

A Flexible Analytical Electronic Laboratory Notebook

NuGenesis ELN, the analytical electronic laboratory notebook (ELN) capability of the NuGenesis Lab Management System, allows laboratories to document observations, control procedures, exchange information with other software solutions, and easily find and collaborate on scientific results. NuGenesis ELN optimizes the utilization of information collected and cataloged by NuGenesis SDMS. With an open and flexible design, NuGenesis ELN easily adapts to fit and support existing free-flow or prescribed workflows in your lab.

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Overview

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Application Notes

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Empower and MassLynx Software are easily accessed and utilized within 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

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In this workflow, the execution method receives samples via bar codes and manages samples throughout the testing. Next, the laboratory equipment is verified to confirm fit-for-use and traceable information which is recorded in the execution method.

Search Capabilities

With NuGenesis ELN, create a query against a single or multiple database to locate data that otherwise would take hours or days to find looking through paper documentation. Search capabilities include:

Document content
Metadata (data about data)
Administrative information
Structure/spectrum search

Information Accessibility

NuGenesis ELN automatically imports information - integrate captured information from the NuGenesis SDMS repository into NuGenesis ELN documents or integrate content managed by other software:

Spreadsheet programs
Structure editors
Image editors’ statistics software
Word processing software
Text, reports, and comments

Integrate with Other Information Systems

NuGenesis ELN provides open interfaces to other information systems, including:

Laboratory Information Management Systems (LIMS)
Enterprise Resource Planning (ERP), e.g. SAP
Chemistry related information systems, such as instrument/chromatography data systems (i.e., Empower and MassLynx Software)

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.

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