Garrett O. Mullen - Waters Corporation · The electronic alternative to the paper lab notebook...
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©2012 Waters Corporation 1
Garrett O. Mullen
©2012 Waters Corporation 2
NuGenesis 8 Featuring Lab Execution Technologies
©2012 Waters Corporation 3
NuGenesis 8 Featuring Lab Execution Technologies
Capture
Catalog
Data Reuse
E-Records Lifecycle Management
©2012 Waters Corporation 4
NuGenesis SDMS 8
Captures and catalogs all data types - files & documents
Easy search, retrieval and re-purposing
Web browser based
Compliant ready
Data Retention Policy Aware
R&D, QA, Business
The CorporateKnowledge Center
©2012 Waters Corporation 5
The Power of Integrating SDMS into Your Overall Business Process
Data Consumers
Data SourcesLab Instrumentation Office
Applications
Waters NuGenesis SDMS
View
Extract
LIMSVisualizationand Analytics
SoftwareData
WarehousesDiscovery
and ClinicalDatabases
©2012 Waters Corporation 9
NuGenesis 8 Featuring Lab Execution Technologies
One ELN
Free Flow - Unstructured
Process Driven - Structured
©2012 Waters Corporation 10
ELN 8
User Configured for any laboratory typeGeneral purpose digital annotation toolConsolidated Documentation/ annotationInventory Management– Reagents/Instruments
Sample TrackingReporting– Scientific– Business– Legal / Patent (IP)
Traceability to source dataCompliant ready
The electronic alternative to the paper lab notebook
©2012 Waters Corporation 11
ELN Document Editor
©2012 Waters Corporation 12
Embed Applications
Integrate software via COM technology
©2012 Waters Corporation 13
Integrate Templates
Save time with pre-formatted entriesEasy to fill out with less errors and higher content quality, e.g. use Microsoft Word forms to create interactive templates
Generate entire document templates
Use existing software templates, e.g. Excel worksheets
Modify and administrate templates within the ELN
©2012 Waters Corporation 14
NuGenesis 8 Featuring Lab Execution Technologies
Instrument Inventory
Consumables Inventory
Fit-For-Use Checks
©2012 Waters Corporation 15
Inventories
©2012 Waters Corporation 16
NuGenesis 8 Featuring Lab Execution Technologies
Empower & MassLynx
Any Scientific Software
Simple Devices
Business Systems
©2012 Waters Corporation 17
SDMS Project Browser
©2012 Waters Corporation 18
Direct Access to Empower
©2012 Waters Corporation 19
Simple Devices -Balance Interface
<CR> 9.876 uni
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
©2012 Waters Corporation 22
NuGenesis 8 Featuring Lab Execution Technologies
Electronic LabExecution Methods
Predefined
Automation
Proper Sequence
©2012 Waters Corporation 23
Combine Procedure and Data Entry Using Electronic Forms
Procedure
Data Entry
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:
©2012 Waters Corporation 24
Invoke SOP from External System
©2012 Waters Corporation 25
Restricted Access to Forms
©2012 Waters Corporation 26
Electronic Signatures & Workflow
©2012 Waters Corporation 27
NuGenesis 8 Featuring Lab Execution Technologies
Manage & TrackSample Test Request
Ensure ProductsMeet Specifications
©2012 Waters Corporation 28
NuGenesis 8Streamline Documentation Workflows
©2012 Waters Corporation 29
Sample Tracking
©2012 Waters Corporation 30
Reporting
©2012 Waters Corporation 31
NuGenesis 8 Featuring Lab Execution Technologies
Compliance Ready
Electronic Records
Electronic Signature
Data & Result Traceability
©2012 Waters Corporation 32
Audit Trail
©2012 Waters Corporation 34
Report Final Results
Create paper-equivalent printouts
Customize layouts
Facilitate hand-written signatures on printed reports
©2012 Waters Corporation 37
IP Protection and Security
In order to be a true replacement for paper notebooks electronic versions need– a sustainable reviewing and witnessing process
– high level of transparency for all entries made in the notebook
– solid content protection and anti-fraud provisions
The overall concept must give higher security than the paper process in addition to productivity gains and corporate advantages
©2012 Waters Corporation 38
Making the Transition
Make all disparate data work togetherSolve data variabilityReduce high administrative costs and non-value added tasksShare and collaborate across the enterpriseComply with 21 CFR 11 and IP needs
Waters Laboratory Informatics…makes it happen!!!
©2012 Waters Corporation 39
Enterprise Solutions - Service Offerings
Planning & Consulting
Project Management
Implementation Support
Integration Services
Validation
Training
Maintenance & Support
©2012 Waters Corporation 40