©2013 Waters Corporation 1
Overview of NuGenesis 8 ELN
©2013 Waters Corporation 2
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
©2013 Waters Corporation 3
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
©2013 Waters Corporation 4
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
?
©2013 Waters Corporation 5
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
©2013 Waters Corporation 6
My Work
©2013 Waters Corporation 7
Sample Management
Manage test request, samples, and results
Track samples through your labs
User Centric approach
©2013 Waters Corporation 8
Test Request and Sample Management – My Work: Samples
©2013 Waters Corporation 9
Test Request and Sample Management – My Work: Requests
©2013 Waters Corporation 10
Test Request and Sample Management – My Work: Tests
©2013 Waters Corporation 11
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
©2013 Waters Corporation 12
NuGenesis 8 Freeflow Lab Notebook
Introduction Experimental
Results
Conclusions
©2013 Waters Corporation 13
Test Execution with Templates
©2013 Waters Corporation 14
Test Preparation and Specifications - Electronic Lab Execution Methods
SOP
Data Entry
©2013 Waters Corporation 15
Automate Calculations
©2013 Waters Corporation 16
Built-in Intelligence of Test Documentation
Transferred from SAP
Information from Instrument Inventory
Scanned Bar Codes
©2013 Waters Corporation 17
Find Your Data in NuGenesis 8 eLN
Content Search
Search for metadata
Chemical structure search
Search for Spectra/Chromatograms
©2013 Waters Corporation 18
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
©2013 Waters Corporation 19
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
©2013 Waters Corporation 20
<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
©2013 Waters Corporation 21
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?
©2013 Waters Corporation 22
Review and Approval – Signature Workflow Automation
Weight conformity for Batch 264547 for Approval
please could you approve these weight conformity results for Batch 264547
©2013 Waters Corporation 23
Review and Approval – Sample Overview
ERP
©2013 Waters Corporation 24
Reporting
Analytical report for test request
Persistent report for all test documents
Allows adding custom reports
©2013 Waters Corporation 25
Reporting
©2013 Waters Corporation 26
Out of the box integration...with NuGenesis 8
Instrument
Business Systems
©2013 Waters Corporation 27
Direct access to Empower
NuGenesis ELN Empower Browser
©2013 Waters Corporation 28
Documents Integration with Empower
Analyst clicks the Submit Samples button to send to Empower
©2013 Waters Corporation 29
Documents Integration with Empower
Click Results button to retrieve results from Empower
©2013 Waters Corporation 30
Direct Access to SDMS Repository
©2013 Waters Corporation 31
Reusing the Data in SDMS
No transcription or cut and paste or checking
©2013 Waters Corporation 32
Reusing the Data in SDMS
Automatically Calculates results that were not carried out in the native software
©2013 Waters Corporation 33
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
©2013 Waters Corporation 34
SAP Create Inspection Lot
©2013 Waters Corporation 35
NuGenesis eLN -Request Overview
©2013 Waters Corporation 36
NuGenesis eLN 8-Request Worksheet Creation
©2013 Waters Corporation 37
NuGenesis eLN 8-Test Worksheet pH
©2013 Waters Corporation 38
NuGenesis eLN 8-Review Results
©2013 Waters Corporation 39
NuGenesis eLN 8-Request Overview Result transfer to SAP
Results have transferred back
to SAP
©2013 Waters Corporation 40
SAP Characteristic Details
©2013 Waters Corporation 41
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
©2013 Waters Corporation 42
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
©2013 Waters Corporation 43
Questions?
©2013 Waters Corporation 44