WATERS NuGENESIS LAB MANAGEMENT SYSTEM

Transcription

1 WATERS NuGENESIS LAB MANAGEMENT SYSTEM Waters NuGenesis Lab Management System uniquely combines synergistic data, workflow and sample management capabilities to support the entire product lifecycle from discovery through manufacturing. This user-centric platform encompasses NuGenesis SDMS, a compliance-ready data repository, NuGenesis ELN, a flexible analytical electronic laboratory notebook, and NuGenesis Sample Management. NuGenesis provides a synergy of information management technologies unlike anything available in the market today. Capabilities such as sample management, workflow support, integration of third party software and organizations, data retention and legal hold, and stability testing allow NuGenesis to connect the scientific data from your laboratories to the business systems of your organization more effectively than ever before.

2 TABLE OF CONTENTS INTRODUCTION... 3 Platform Support... 4 NuGENESIS SDMS UPGRADES... 5 User Interface... 5 Administrative Dashboard and Logging... 5 Audit Trail... 5 Data Retention... 5 Paradigm Scientific Search... 5 Language Support... 5 Example Projects... 5 Application Specific Data Adapters... 5 NuGENESIS ELN UPGRADES... 6 Empower/SDMS Interface... 6 Reporting Framework... 6 Template Management... 6 Menu Items for Custom Form Calls... 6 Training Records... 6 User Interface... 6 NuGENESIS SAMPLE MANAGEMENT NEW... 6 NuGenesis Connectors... 6 NuGenesis SampleShare... 6 NuGenesis Stability... 6 Specification Management... 6 User Interface... 6 Notice The information in this document is subject to change without notice and should not be construed as a commitment by Waters Corporation. Waters Corporation assumes no responsibility for any errors that may appear in this document. This document is believed to be complete and accurate at the time of publication. In no event shall Waters Corporation be liable for incidental or consequential damages in connection with, or arising from, the use of this document. For updated information, please refer to the Release Notes. 2

3 INTRODUCTION NuGenesis Lab Management System is the next significant milestone in the history of the NuGenesis platform. With further enhanced Data Retention Management and Legal Hold capabilities, integration of Waters Paradigm Scientific Search, and an all new administrative dashboard, NuGenesis SDMS does not only cover the entire scientific data lifecycle from beginning to end in a compliant, secure environment, but also takes finding data and managing systems to a whole new level. NuGenesis ELN covers all your lab execution, testing workflow, and integration needs with comprehensive features for tracking, assigning, and managing samples, tests, and results; an easy to use web interface for submitting samples; secure integration of data from external labs; and industry-leading stability testing support. Together with a growing family of interfaces with popular lab IT systems, the lab and busy have never been more connected. 3

4 Platform Support NuGenesis Component(s) Validated Operating Systems, Browsers, and Databases Web application servers with IIS 7.5 JBoss 5 (for ELN, included) Tomcat (for SDMS, included) Java Runtime Environment Standard Edition 1.6/1.7 U 2 (included) VISION web client, including Preview (print data viewer), and InSpector data viewer, Help Desk web client, Audit Trail viewer Restore (file data restoration) NuGenesis ELN client UNIFY print capture modules, UNIFYps, SDMS administrator File capture modules, SCC Oracle server Oracle client User identity servers supported for authentication Data source operating systems for file data Data source operating systems for print data through the UNIFY print capture modules Supported OS languages (Internet Explorer 11 in Compatibility Mode) (Internet Explorer 8) Windows 7 Professional or Enterprise SP1 32 bit (Internet Explorer 8 + Internet Explorer 9 in Compatibility Mode) Windows 7 Professional or Enterprise SP1 64 bit (Internet Explorer 8 + Internet Explorer 9 in Compatibility Mode + Internet Explorer 10 in Compatibility Mode + Internet Explorer 11 in Compatibility Mode) (Internet Explorer 8).NET 4.5 is required Windows Server 2003 R2 SP2 32 bit (Standard Edition; UNIFY only), Windows 7 Professional or Enterprise SP1 64 bit Oracle Server on, Sun Solaris UNIX Version 10, IBM AIX 6.1 Red Hat Enterprise Linux AP 5.6 (64 bit) on x86-64 Red Hat Enterprise Linux AP 6.2 (64 bit) on x86-64 Oracle Client on Windows Server 2003 R2 SP2 (for use with Administrator only) Microsoft Active Directory (Mixed Mode) on Please note that even though the file capture modules support all of the operating system entries above, data adapters that require a client application are restricted to those operating systems supported by that application as noted in section 5.c - Application-specific data adapters. English, Japanese, Korean, Russian, Simplified Chinese For more details, please contact Waters Technical Support. 4

5 NuGENESIS SDMS UPGRADES User Interface The VISION user interface has been redesigned for a more modern look and feel as well as improved ease of use. Administrative Dashboard and Logging The NuGenesis Lab Management System brings extended logging of events and metrics on the backend components (servers, archive agent, data management, off-line storage management, and transport engine). This rich information can now be processed in the dashboard option (powered by SolarWinds) for near-realtime insight into the system s health. Audit Trail Easily find audit trail information on one or more records from the VISION user interface. Data Retention Enhanced support for data retention policies and legal hold with automatic application of legal holds and reports on configuration and record status; SDK support. Example Projects NuGenesis comes with several example projects for use with: Waters Empower Software Archived Empower projects Empower reports AQT reports SystemsQT reports Waters MassLynx Software AB Sciex Analyst Agilent ChemStation Thermo Scientific Xcalibur Bruker BioSpin HyStar/Compass These projects are also included on the NuGenesis installation media and feature: File Capture templates for use with Empower and standard mass spectrometry software Print Capture templates for default reports Predefined NuGenesis SDMS projects with tag values and views Paradigm Scientific Search Paradigm Scientific Search, an alternative searching mechanism with unparalleled added capabilities, is integrated in the Nugenesis Software. Language Support Supports English, Japanese, Korean, Russian, and Simplified Chinese language environments. Application-Specific Data Adapters Vendor Product / Version Data Element File Proxy JCAMP-DX Application Product Type Pattern Enabled Conversion Client Required Technique ABI-Sciex Analyst File-based *.wiff, (*.wiff. scan), *.rdb No No Yes LC/MS 5

6 NuGENESIS ELN UPGRADES Empower/SDMS Interface The Empower and SDMS interface of the NuGenesis ELN includes new functionality and ergonomic enhancements. The functionality reduces the number of mouse clicks required to transfer Sample Set and Results Data to and from Empower and SDMS. This tool helps you more easily leverage the data and information collected in these two systems and repurpose it within your technical worksheets and documentation. All while reducing transcription errors and increasing the rate at which information is being gathered and processed and strengthening your compliance with regulations like 21 CFR Part 11 and Annex 11. Reporting Framework The enhanced reporting framework supports the definition of report templates with configurable input parameters that a user can enter at runtime to get the information they are looking for. The reports can be exported into various formats (e.g., HTML, CSV, TEXT, and EXCEL). Based on the new reporting framework there is a variety of standardized out-of-the-box reports that provide metrics and lab statistics information to the user. Template Management To reduce the number of overall templates and minimize the validation efforts, it is now possible to manage a list of parameters and multiple sets of values for the parameters that are stored with the template definition. When a document is generated based on a parameterized template, a set of parameter values is used to initialize the document parameters. Menu Items for Custom Form Calls It is now possible to integrate menu items to call custom forms and third party plug-ins. The plug-ins can be integrated into the UI as menu entries/shortcuts or as additional actions in the My Work pages or Document Editor. Training Records There is a new dedicated screen to track the training records for users that control the access to a template. NuGENESIS SAMPLE MANAGMENT NEW The Sample Management functionality of the NuGenesis ELN allows for more flexibility concerning the usage and visualization of information (fields) on request, test and sample level. NuGenesis Connectors NuGenesis Connectors are configurable utilities that provide a direct link between the NuGenesis Lab Management System and business systems such as SAP. This link facilitates seamless communication of instructions and information including test requests, standard operating procedures (SOPs), product specifications, and test results. NuGenesis SampleShare A web-based sample submission client enables users to securely register samples in NuGenesis from any browser. This allows a seamless transfer of sample data to and from any external laboratory, business unit, or customer. NuGenesis Stability NuGenesis Stability is a complete stability protocol management and testing solution integrated into the NuGenesis Laboratory Management System. Developed in accordance with the current GAMP and ICH guidelines, it is a fully validated and tested software application that uses industry-recognized calculations. Specification Management The specification management module has been enhanced to support the definition of product specifications including products, tests, references to analytical procedures (methods) and acceptance criteria on result level. Additionally it is possible to define limits for multiple countries within one specification. User Interface Updates To improve the sample management user experience, various improvements have been made for a better visual indication of status information and exceptions that have occurred based on entered results that are off-limit. User Interface Updates To improve the sample management user experience, various improvements have been made for a better visual indication of status information and exceptions that have occurred based on entered results that are off-limit. 6

7 Waters, Empower, MassLynx, NuGenesis, and The Science of What s Possible are registered trademarks of Waters Corporation. NuGenesis SampleShare and Paradigm are trademarks of Waters Corporation. All other trademarks are the property of their respective owners Waters Corporation. Produced in the U.S.A. July EN LM-PDF Waters Corporation 34 Maple Street Milford, MA U.S.A. T: F: