ELN[ NuGENESIS ELN ]
TAKE CONT ROL OF YOUR LABORATORY WORKFLOW
FLEXIBLE
ELECTRONIC LABORATORY NOTEBOOK CREATES A SINGULAR INFORMATION MANAGEMENT PLATFORM
Waters® NuGenesis® ELN, the analytical
electronic notebook capability of
the NuGenesis Lab Management
System, adds a new dimension to the
processing, controlling, documenting,
and reporting of scientific results.
NuGenesis Scientific Data
Management System (SDMS)
data repository allows you to
collect and catalog all of your
scientific information generated
in the laboratory. NuGenesis
ELN optimizes your ability to
interactively process, interpret,
and report on that information.
This increases the efficiency
of individual analysts and
adds significant value to your
laboratory’s output.
NuGenesis ELN’s flexible
design helps organizations
improve laboratory workflow
in free-flow documentation
environments, such as R&D, and
process driven environments,
such as late-stage development
and quality control.
A FOCAL POINT FOR EX ECUT ING ANALYT ICAL T EST ING MET HODS
NuGenesis ELN facilitates the integration of
information originating from instrument software,
Laboratory Information Management Systems
(LIMS), and Enterprise Resource Planning (ERP)
systems, to better streamline laboratory processes.
With NuGenesis ELN, you get a complete and
secure analytical chemistry electronic laboratory
notebook, along with a laboratory execution
system, in a single solution.
The combined functionalities of NuGenesis
SDMS and NuGenesis ELN are ideally suited for
organizations challenged with:
■■ Documenting the free flow of scientific
observations and results while safeguarding
intellectual property rights
■■ Documenting analytical test execution
with Standard Operating Procedure
(SOP) worksheets
■■ Using spreadsheets while employing
electronic document safeguards (GxP)
■■ Creating custom reports in support of
study summaries, instrument use, method
development and validation, and more
■■ Electronic Common Technical Documents
(eCTDs)
■■ Abbreviated New Drug Applications (ANDAs)
■■ Keeping track of reagent and solution
consumption, instrument use, and calibration
■■ Sample management
[ NUGENESIS ELN ]
Eliminate static laboratory recordkeepingNuGenesis ELN dramatically improves how
you manage data, results, and routine
procedures in a compliance-ready and
intellectual property secured scientific
authoring environment. NuGenesis ELN
eliminates the need for traditional static
laboratory recordkeeping by delivering a
new level of dynamic content availability.
■■ Addresses the entire scientific content
lifecycle: from documenting and storing
the initial thoughts of your key researchers
to managing data across discovery,
development, and production
■■ Integrates with a majority of software
programs, with advanced interoperability
with Waters’ Empower,® NuGenesis SDMS,
and MassLynx® Software
NuGenesis ELN is a portal to all data of the lab operation. Personalized dashboards provide an overview about the status of your work.
KEY FEATURES AND BENEFITS OF NuGENESIS ELN
■■ Document the findings of
scientists in discovery and
early development, or guide
analysts through process-
driven worksheets in
late development and
quality control
■■ Increase the utility of
information collected
by NuGenesis SDMS
■■ Automate routine
calculations
■■ Drag-and-drop documents,
such as PDFs or Microsoft®
Word and Excel, directly into
NuGenesis ELN to streamline
laboratory documentation
■■ Work with Microsoft Excel
in a compliance-ready
environment
■■ Easily compare and contrast
results from different
analytical techniques
and vendors
■■ Tightly control experimental
results to ensure intellectual
property traceability
■■ Track samples and test
requests through their
entire lifecycle
■■ Make decisions faster in an
operationally consistent
and efficient environment
■■ Help satisfy compliance
requirements
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 forms can easily be
migrated into NuGenesis ELN
■■ Built-in inventories for
instruments and reagents
■■ With a web-based interface,
ELN documents are accessible
for review and approval through
any desktop workstation
Eliminate static laboratory recordkeeping IMPROVE LABORATORY EFFICIENCY FOR FREE-FLOW DOCUMENTATION
Use Microsoft Excel spreadsheets while employing electronic document safeguards (GxP).
Empower and MassLynx Software are easily accessed and utilized within NuGenesis ELN.
SAMPLES
R ESULT S
NuGenesis Lab Management System
combines the power of NuGenesis SDMS
and NuGenesis ELN to yield a workflow
software package designed to guide the
laboratory analyst through a routine,
comprehensive standard operating
procedure (SOP). Analysts can integrate
results from other lab IT systems, including
a chromatography data system, such
as Empower 3 Chromatography Data
Software (CDS).
Manual or paper-driven guidelines still
dominate certain laboratory functions,
especially those focused on method or
analytical SOPs. NuGenesis addresses the
predominantly manual activities required
to perform an analytical method or test.
This supports a “right the first time”
philosophy – reducing cycle times by
50% to 75%, compared to a traditional
paper trail with fewer opportunities for
human error.
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
Facilitate SOP method generation NuGenesis Lab Management System
facilitates SOP/GxP method generation by
including a laboratory execution method
editor to guide the author through the
necessary steps to create a predefined
template. For example, the method editor
allows the author to define input and
output fields, define acceptance criteria for
data input, and link external data sources
to the electronic method (e.g., linking a
sample weight field with input from an
electronic balance).
Streamline workflows
The laboratory execution method not only
guides the analyst through the prescribed
workflow (without skipping required
steps), but it also verifies that input meets
established criteria (e.g., by only allowing
the use of calibrated balances and fresh
stock solutions). The laboratory execution
method accepts data from external sources
(CDS, LIMS, pH meters, balances, etc.),
and readily incorporates results acquired
on external data acquisition systems back
to the completed method, reducing the
risk of transcription errors. The resulting
document is electronically searchable,
thus facilitating comparisons between
previous studies. Finally, the review and
approval process is streamlined because
it is accomplished electronically.
With NuGenesis, you can implement “right the first time” data capture in your lab. Ensure that the correct version of the SOP is being used and personnel are trained to execute it, control workflow by enforcing order of execution, and automate the capture of simple device data and documentation in one interface.
NuGENESIS LAB MANAGEMENT SYSTEM FOR PROCESS-DRIVEN SOP WORKFLOWS
[ NUGENESIS ELN ]
[ FOLIO INSIDE HEADER ]
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Laboratory execution methods help reduce the time and errors associated with tasks that depend on paper guidelines, including:
■■ Instrument checks
■■ Standards and sample preparation
■■ Solvent and mobile phase preparation
■■ Analysis review
■■ Results approval
■■ Final product release
Access your scientific results and conclusions
NuGenesis ELN allows scientists to document
their experiments, then capture, process,
record, search, and share data of all types in
a completely digital workspace. Manage text,
reports and comments, spreadsheets and
tables, images, movies, chemical structures,
and reactions, along with analytical data
such as spectra and chromatograms.
NuGenesis ELN automatically imports
information – you can integrate captured
information from the NuGenesis SDMS
repository into NuGenesis ELN documents,
or integrate content managed by word
processing software, spreadsheet programs,
structure editors, image editors, statistics
software, and more. File data, whether from
the file system or from instrument servers,
can be uploaded manually or automatically
via the NuGenesis SDMS data repository,
which takes advantage of integrated
agents for file capture, file parsing,
and metadata extraction.
Creating a corporate knowledge infrastructure
NuGenesis ELN enables your analytical
research, development, and QC
organizations to work as a team
like never before.
With laboratories networked through a
common electronic interface and your
research findings documented, secured,
and available in a centralized pool – your
company can leverage the accessibility of
the collective knowledge and experience
of your entire organization. You will gain
valuable insight into experimental results
and information generated by other labs
that can save you time and positively
support your hypotheses and analyses.
With a flexible and open design, regulate the flow of information for electronic review, approval, sign-off, and publishing of consolidated final results, building sequential methods to automate a consistent process where required.
Predefined views allow analysts to
easily find the work assigned
to them.
Powerful searches are easy to execute
Searching with NuGenesis ELN is easy and
powerful. Create a query against a single
or multiple databases to locate data that
otherwise would take hours or days to find
by looking through paper documentation.
You can set up searches as broad or specific
as you need. Search capabilities include:
■■ Document content, sections,
workspaces, and their attachments
with text comments
■■ Metadata (data about data)
■■ Administrative information■■ Identifier■■ Status■■ Title■■ Laboratory project■■ Author■■ Date/time of creation■■ Signer(s)■■ Date/time of signature(s)■■ Comments and more
■■ Structure/spectrum search
Designed for long-term integrity
Data storage and electronic recordkeeping
in NuGenesis ELN are designed for
long-term integrity. Contents are stored
without modification in a one-to-one
electronic record with all related metadata,
retaining information about how, when,
and by whom certain data was collected
and the data format. Information is
saved independently from its originating
software and is stored in stable, standard
data formats – ready for you to retrieve
when you need them.
Security, evidence protection, and compliance
NuGenesis Lab Management System is
designed to be compliance-ready and
has a Certificate of Structural Integrity to
support users in a regulated environment.
The Certificate of Structural Integrity is
signed and approved by the Director of
Worldwide Quality.
It also enables you to meet cGxPs, EU
GMPs, and other regulatory requirements
worldwide for users of this product.
NuGenesis Lab Management System allows
you to be compliance-ready for 21 CFR
Part 11, and the U.S. FDA’s Electronic
Records and Signature Rule:
■■ Time stamping, with role and status-
based user access and inactivity logouts
■■ Configurable and flexible electronic
signature and workflow for all
documents and content
■■ Version control with full audit trails –
including system and document
audit trails
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.
With NuGenesis ELN, you can easily track your sample and test requests through their entire lifecycle in the laboratory.
[ NUGENESIS ELN ]
Waters Corporation 34 Maple Street Milford, MA 01757 U.S.A. T: 508 478 2000 F: 508 872 1990 www.waters.com
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