Solution

Solutions for the pharmaceutical and medical device industry

Quality Test Management SolutionWaters NuGenesis LMS

Waters® NuGenesis® LMS (LMS) is a system that centralizes all data related to quality testing. Manage test equipment data and raw data using Scientific Data Management System (SDMS), a scientific information data management system, and create experiment notebooks using Electric Laboratory Notebook (ELN) to improve data life. Achieve data integrity throughout the cycle.
As a Waters Informatics Strategic Partner, B-EN-G supports the implementation of NuGenesis license sales and server installation, system management settings, analysis and test record template creation, device connection settings, and other system linkage construction.

overview

LMS consists of two modules: the scientific information data management system SDMS and ELN.
SDMS automatically backs up raw data files, imports and centrally manages report print images from analytical instruments, regardless of manufacturer or type of analytical instrument.
ELN records equipment data, final calculation results, etc. in an electronic laboratory notebook, and can be managed in one system, including electronic signatures for reviews and approvals.
The biggest feature of NuGenesis LMS is that you can freely define test records even if you are not a system expert, and laboratory members can independently maintain and maintain test records.

Module functionality

SDMS
  • Regardless of manufacturer or type of analytical equipment, it automatically backs up raw data files and imports print images of reports from analytical equipment for centralized management.
  • It supports not only analysis data but also files such as PDF, Word, Excel, and data from various applications.
ELN
  • You can use Excel or Word as is in your notebook, and you can flexibly use data from analytical instruments imported into SDMS.
  • Measurement data can be directly imported from analytical equipment with RS232C serial communication function.
  • It also has sample management functions, reagent/sample management functions, and analytical equipment management functions.
  • With the addition of stability testing options, you can manage everything from stability testing planning to statistical analysis of results.

Example of data flow when using SDMS

data flow

Effects of introduction

Regulatory compliance
  • Data integrity compatible
  • Compatible with laws and regulations of each country
  • (GMP, GQP, GCP, GLP, etc.) Audit trail
  • Electronic signature
  • security
Centralized management of test data and raw data
Data from various analytical instruments and files such as Word and Excel can be imported into SDMS and managed centrally.
Digitization of experiment notebooks (paperless)
A single system can manage not only manual records, equipment data, final calculation result data, etc. generated during analysis work, but also reviews and approval records using the workflow function.

Efficient implementation with B-EN-G’s data integrity templates

At B-EN-G, based on our experience with multiple NuGenesis implementations, we have created components that can be shared, such as function settings, and have prepared them as templates.
When introducing a new product, we will efficiently introduce it by having you use this template "DI compatible template" as is or with some modifications.

Advantages of introducing DI compatible templates
  • Quality assurance
  • Short-term introduction
  • Improving the efficiency of testing work
  • Cost reduction

Material download

You can download the following materials.

  • Data integrity in the pharmaceutical industry and B-EN-G's quality test management solution ~NuGenesis LMS~
    An explanation of the data integrity required in the pharmaceutical industry, the role played by the quality test management solution NuGenesis LMS, and B-EN-G system implementation support services such as CSV.
  • NuGenesis Overview
    Describes issues in quality testing operations, the direction of their resolution, and an overview of the quality testing solution "NuGenesis"
  • NuGenesis screen collection
    Describes representative screens and explanations for each function in the "Operation Image" chapter of the "NuGenesis Overview" above.
Material download
NuGenesis LMS documentation
  • Download Data Integrity Measures Materials
    We have prepared materials that summarize key guides, guidance, and specific solutions related to data integrity.
Material download