Garrett O. Mullen Waters Corporation 1

Transcription

1 Garrett O. Mullen 2012 Waters Corporation 1

2 NuGenesis 8 Featuring Lab Execution Technologies 2012 Waters Corporation 2

3 NuGenesis 8 Featuring Lab Execution Technologies Capture Catalog Data Reuse E-Records Lifecycle Management 2012 Waters Corporation 3

4 NuGenesis SDMS 8 Captures and catalogs all data types - files & documents Easy search, retrieval and repurposing Web browser based Compliant ready Data Retention Policy Aware R&D, QA, Business The Corporate Knowledge Center 2012 Waters Corporation 4

5 The Power of Integrating SDMS into Your Overall Business Process Lab Instrumentation Data Sources Office Applications View Waters NuGenesis SDMS Extract LIMS Visualization and Analytics Software Data Warehouses Discovery and Clinical Databases Data Consumers 2012 Waters Corporation 5

6 NuGenesis 8 Featuring Lab Execution Technologies One ELN Free Flow - Unstructured Process Driven - Structured 2012 Waters Corporation 9

7 ELN 8 User Configured for any laboratory type General purpose digital annotation tool Consolidated Documentation/ annotation Inventory Management Reagents/Instruments Sample Tracking Reporting Scientific Business Legal / Patent (IP) Traceability to source data Compliant ready The electronic alternative to the paper lab notebook 2012 Waters Corporation 10

8 ELN Document Editor 2012 Waters Corporation 11

9 Embed Applications Integrate software via COM technology 2012 Waters Corporation 12

10 Integrate Templates Save time with pre-formatted entries Easy 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 13

11 NuGenesis 8 Featuring Lab Execution Technologies Instrument Inventory Consumables Inventory Fit-For-Use Checks 2012 Waters Corporation 14

12 Inventories 2012 Waters Corporation 15

13 NuGenesis 8 Featuring Lab Execution Technologies Empower & MassLynx Any Scientific Software Simple Devices Business Systems 2012 Waters Corporation 16

14 SDMS Project Browser 2012 Waters Corporation 17

15 Direct Access to Empower 2012 Waters Corporation 18

16 Table Continued. H2O-01 Waters 10-Feb SrN B4 34 Maple Street, Milford MA Phone: Fax: Nov-07 Simple Devices - Balance Interface <CR> unit mg 09/08/2008 wli4345a tare y<cr><lf> mg Stock No Stock Preparation Step 1: Weigh the following into a clean dry 100 ml class "A" volumetric flask. Compound Source Exp Desired (mg) Actual (mg) a: Diphenhydramine VMR 22-Nov b: Pseudoepherine HCL Bayer 11-Jan c: Dextromethorphan HBr BASF 10-Feb mg Batch No. a: Diphenhydramine DIP-003 b: Pseudoepherine HCL PSD-02 c: Dextromethorphan HBr Dextromethorphan Hbr Step 2: Add 50 ml of purified WaterDextromethorphan HBr Compound Source Exp Desired (ml) Actual (ml) Note: Swirl (sonicate if necessary) to dissolve completely. Step 3: Add purified Water to volumetric flask bringing solvent level to 100 ml. Standard Details: Acceptable ( Conc (mg/ml) Total (mg) Std. A N Balance Details: Balance ID No. Cal/Qual Date Confidential. <CR> uni 2012 Waters Corporation 19

17 NuGenesis 8 Featuring Lab Execution Technologies Electronic Lab Execution Methods Predefined Automation Proper Sequence 2012 Waters Corporation 22

18 Combine Procedure and Data Entry Using Electronic Forms Stock No Maple Street, Milford MA Phone: Fax: Stock Preparation Procedure Step 1: Weigh the following into a clean dry 100 ml class "A" volumetric flask. Compound Source Exp Desired (mg) Actual (mg) a: Diphenhydramine VMR 22-Nov b: Pseudoepherine HCL Bayer 11-Jan c: Dextromethorphan HBr BASF 10-Feb Table Continued. Batch No. a: Diphenhydramine DIP-003 b: Pseudoepherine HCL PSD-02 c: Dextromethorphan HBr Dextromethorphan Hbr Step 2: Add 50 ml of purified WaterDextromethorphan HBr Compound Source Exp Desired (ml) Actual (ml) H2O-01 Waters 10-Feb Note: Swirl (sonicate if necessary) to dissolve completely. Step 3: Add purified Water to volumetric flask bringing solvent level to 100 ml. Standard Details: Acceptable ( Conc (mg/ml) Total (mg) Std. A N Balance Details: Balance ID No. Cal/Qual Date SrN B4 4-Nov-07 Confidential. Data Entry 2012 Waters Corporation 23

19 Invoke SOP from External System 2012 Waters Corporation 24

20 Restricted Access to Forms 2012 Waters Corporation 25

21 Electronic Signatures & Workflow 2012 Waters Corporation 26

22 NuGenesis 8 Featuring Lab Execution Technologies Manage & Track Sample Test Request Ensure Products Meet Specifications 2012 Waters Corporation 27

23 NuGenesis 8 Streamline Documentation Workflows 2012 Waters Corporation 28

24 Sample Tracking 2012 Waters Corporation 29

25 Reporting 2012 Waters Corporation 30

26 NuGenesis 8 Featuring Lab Execution Technologies Compliance Ready Electronic Records Electronic Signature Data & Result Traceability 2012 Waters Corporation 31

27 Audit Trail 2012 Waters Corporation 32

28 Report Final Results Create paper-equivalent printouts Customize layouts Facilitate hand-written signatures on printed reports 2012 Waters Corporation 34

29 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 37

30 Making the Transition Make all disparate data work together Solve data variability Reduce high administrative costs and non-value added tasks Share and collaborate across the enterprise Comply with 21 CFR 11 and IP needs Waters Laboratory Informatics makes it happen!!! 2012 Waters Corporation 38

31 Enterprise Solutions - Service Offerings Planning & Consulting Project Management Implementation Support Integration Services Validation Training Maintenance & Support 2012 Waters Corporation 39

32 2012 Waters Corporation 40