Overview of NuGenesis 8 ELN - Waters Corporation · Provides a high level overview of the use of NuGenesis 8 ELN in the analytical laboratory. Illustrate the flexibility of NuGenesis

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Overview of NuGenesis 8 ELN


Agenda

Provides a high level overview of the use of NuGenesis 8 ELN in the analytical laboratory.

Illustrate the flexibility of NuGenesis ELN for spanning from research, development, and quality control.

Explore the difference between NuGenesis ELN as a laboratory journal for protecting intellectual property in the research arena and Laboratory Execution capabilities when deployed in QC


NuGenesis 8

1. Comprehensive laboratory workflow and documentation solution

2. Integration of business and laboratory systems

3. Supports entire product lifecycle from research to manufacturing

Laboratory Instruments

Business Systems

Research QC Development

Sampling Testing Evaluation Release Reporting Request Manage Data

NuGenesis 8

NuGenesis 8

NuGenesis 8 NuGenesis 8


Major Types of Testing

Discovery, Investigative – Free-flow

– Geared towards new scientific discoveries

– Seeks to protect intellectual property rights

Process Driven, Investigative – Follows established methods

– Geared towards repeat tasks

– Often used to compare to regulations e.g. USP, DEFRA

Maze obtained from pbs.org

Test Test

?


One Platform across all Development?

GxP

Often SOP and workflow driven

Includes repetition

Can be streamlined and improved by standardization

Higher degree of automation and reduction of manual steps possible

Non-GxP

Innovation is basic – but standardization needed for consistent approach

Integration of science across the organization as critical as single innovation

Follow your rules – but remain flexible


My Work


Sample Management

Manage test request, samples, and results

Track samples through your labs

User Centric approach


Test Request and Sample Management – My Work: Samples


Test Request and Sample Management – My Work: Requests


Test Request and Sample Management – My Work: Tests


User Centric Design

Needs overview about the status of the work

Assign tests to analysts

Needs overview entire request context

Review test documents

Approve test requests

Find all pending tests that are relevant for them

Calibrate instruments

Run and document the actual tests

Check in/out samples

Print sample labels


NuGenesis 8 Freeflow Lab Notebook

Introduction Experimental

Results

Conclusions


Test Execution with Templates


Test Preparation and Specifications - Electronic Lab Execution Methods

SOP

Data Entry


Automate Calculations


Built-in Intelligence of Test Documentation

Transferred from SAP

Information from Instrument Inventory

Scanned Bar Codes


Find Your Data in NuGenesis 8 eLN

Content Search

Search for metadata

Chemical structure search

Search for Spectra/Chromatograms


Searching for data in the eLN

Full Text content

Meta Information

Attachments

Comments

Chromatograms

Spectra

Stereoselective Identity Search

Stereoselective Substructure Search

Molecular Formulas

Molecular Masses


Complete Inventory Management

Instrument and Reagents & Solvents inventories

Tightly integrated in the analysis process

Resources and analysis are maintained in the same context

Enhances traceability tremendously


<CR> 9.876 uni

Balance Interface

Stock No. 123456

Compound Source Exp Desired (mg) Actual (mg)

a: Diphenhydramine VMR 22-Nov-07 40 23.13

b: Pseudoepherine HCL Bayer 11-Jan-08 600 6.72

c: Dextromethorphan HBr BASF 10-Feb-08 200 24.16

Table Continued. Batch No.

a: Diphenhydramine DIP-003

b: Pseudoepherine HCL PSD-02

c: Dextromethorphan HBr Dextromethorphan Hbr39398.8115751157

Compound Source Exp Desired (mL) Actual (mL)H2O-01 Waters 10-Feb-08 50 49.98

Acceptable ( Conc (mg/mL) Total (mg)Std. A N 0.05 54.01

Balance ID No. Cal/Qual DateSrN-11679-B4 4-Nov-07

Step 2: Add 50 mL of purified WaterDextromethorphan HBr

34 Maple Street, Milford MA 01757Phone: 1-800-252-4752 Fax: 1-508-482-2004

Stock Preparation

Confidential.

Step 1: Weigh the following into a clean dry 100 mL class "A" volumetric flask.

Step 3: Add purified Water to volumetric flask bringing solvent level to 100 mL.

Note: Swirl (sonicate if necessary) to dissolve completely.

Standard Details:

Balance Details:

<CR> 9.876 unit mg 09/08/2008 wli4345a tare y<CR><LF> 9.876 mg

9.876

9.876 9.876 mg

Interface to any balance

Can also interface via LabX


Review and Approval – Review-By-Exception

Result correct?

Result not modified?

OOS?

Who is responsible?

Result signed?

Reagents fit-for-use?

Instruments fit-for-use?


Review and Approval – Signature Workflow Automation

Weight conformity for Batch 264547 for Approval

please could you approve these weight conformity results for Batch 264547


Review and Approval – Sample Overview

ERP


Reporting

Analytical report for test request

Persistent report for all test documents

Allows adding custom reports


Reporting


Out of the box integration...with NuGenesis 8

Instrument

Business Systems


Direct access to Empower

NuGenesis ELN Empower Browser


Documents Integration with Empower

Analyst clicks the Submit Samples button to send to Empower


Documents Integration with Empower

Click Results button to retrieve results from Empower


Direct Access to SDMS Repository


Reusing the Data in SDMS

No transcription or cut and paste or checking


Reusing the Data in SDMS

Automatically Calculates results that were not carried out in the native software


Integration with SAP QM

SAP QM SAP-eLN interface

NuGenesis 8 eLN

Retrieves Inspection Lots

Inserts Data into VP Sample Repository

Result Upload to SAP

IDI

Retrieves Inspection Lots

Inserts Data into eLN Sample Repository

Retrieves results Result Upload to SAP


SAP Create Inspection Lot


NuGenesis eLN -Request Overview


NuGenesis eLN 8-Request Worksheet Creation


NuGenesis eLN 8-Test Worksheet pH


NuGenesis eLN 8-Review Results


NuGenesis eLN 8-Request Overview Result transfer to SAP

Results have transferred back

to SAP


SAP Characteristic Details


Waters NuGenesis Platform

• Free-flow and regulated Development workflow • SOP driven QC workflow Workflow

• Print and File capture • Data re-use Data Management

• Test Request Management • Sample Tracking Sample Management

• Instrument software • Small lab devices Instrument Integration

• Instruments • Consumables Inventories

• Standard interface layer • SAP certified interface to SAP-QM LIMS/SAP Interface


NuGenesis 8

1. Comprehensive laboratory workflow and documentation solution

2. Integration of business and laboratory systems

3. Supports entire product lifecycle from research to manufacturing

Laboratory Instruments

Business Systems

Research QC Development

Sampling Testing Evaluation Release Reporting Request Manage Data

NuGenesis 8

NuGenesis 8

NuGenesis 8 NuGenesis 8


Questions?
