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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[ NUGENESIS ELN ]

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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