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1 NuGenesis Lab Management System 2014 Waters Corporation 1

2 The Changing Face of Industry What we were hearing from customers:- The analysis is essential, but being able to manage the data is the problem How to rationalize and centralize their business information systems? I need workflow and sample management capabilities but I don t require a full featured LIMS Manage tests and follow protocols with flexibility of working in both structured and unstructured workflows 2014 Waters Corporation 2

3 Challenges in the Industry Revenue at Stake Patent Cliff Competitive Solutions Product Pipeline Cost Control Streamline Development Globalize Operations Simplify Processes Optimize Use of Assets Standardisation Flexible Use of Employees Outsourcing 2014 Waters Corporation 3

4 Challenges at Lab and IT level Simplify Lab Processes Remove Non-Value Added Steps Right First Time Flexible and Manageable Standardization Global Applications Compliance Easy Integration 2014 Waters Corporation 4

5 Current Solutions ERP LIMS A LIMS B ELN A ELN B LES SDMS SDMS SDMS MS Software CDS CDS Instrument Instrument Instrument DISCOVERY DEVELOPMENT QC 2014 Waters Corporation 5

6 The Challenge Current solutions driving Business Systems into the lab often Leave significant gaps Frustrate the users Are difficult to deploy and support Don t deliver the expected Return on Investment Business Systems ERP LIMS ELN Laboratory Systems SDMS CDS Instrument 2014 Waters Corporation 6

7 Solution with NuGenesis LMS Business Systems Business Systems Instrument Instrument Instrument DISCOVERY DEVELOPMENT QC 2014 Waters Corporation 7

8 2014 Waters Corporation 8

9 What is NuGenesis Lab Management System? NuGenesis LMS Data Management (SDMS) o Bring together all the information from all instruments and analytical techniques in a single database o Provide the tools to manage, repurpose, archive, protect and ensure compliance in a single location NuGenesis LMS Laboratory Notebook (ELN) o Provide the tools to document experimental design and results, from free-form R&D environments to process-driven QA laboratories, in a single package NuGenesis LMS Laboratory Management (LMS) o Provide the tools to implement customised workflows, allowing data to be taken from instruments and taken through the entire process to final disposal. o Help eliminate the need for cumbersome, traditional mechanisms for workflow management 2014 Waters Corporation 9

10 NuGenesis Lab Management System 2014 Waters Corporation 10

11 Capturing and Cataloging Scientific Data Sampling Analytical Data Acquisition Data Processing Results Project Auto E-signature File Data Printed Results NuGenesis SDMS Long Term Archive 2014 Waters Corporation 11

12 View Data Without Original Software HPLC Mass Spec NMR Gel Images 2014 Waters Corporation 12

13 View Data With InSpector 2014 Waters Corporation 13

14 Data Management Data Lifecycle Data Retention can be Enabled on a Project Flexible Retention Policies Complete Manual or Automatic Deletion After Expiration Legal Holds will Prevent Any Change or Deletion 2014 Waters Corporation 14

15 New Advanced Search NuGenesis Lab Management System has a new search engine Using Paradigm Scientific Search Is a corporate scientific search New and novel technology Introduced Waters Corporation 15

16 Integrated Paradigm Scientific Search Search NuGenesis and Empower for the following: Text/Key Words Search-by-Document Digital Image Chemical Structure or Chemical Reaction Analytical Dataset Biological Content as Science Objects 2014 Waters Corporation 16

17 NuGenesis Lab Management System 2014 Waters Corporation 17

18 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. DEFRA Test Test Maze obtained from pbs.org 2014 Waters Corporation 18

19 NuGenesis 8 Freeflow Lab Notebook Introduction Experimental Results Conclusions 2014 Waters Corporation 19

20 Any Information Can Be Included Text including tables, pictures etc. Images and drawings Chemical structures and reactions Analytical data such as spectra, chromatograms, properties Biological data Reports Scans, movies... Analytical Data Yield 800 mg (91%) Rf 0.38 (chloroform/ methanol, 30:1) To a solution of dry methyl 1--D-ribofuranosyl-4,5-imidazoledicarbo xylate2 (2) (500 mg, 1.58 mmol) in dry pyridine (10 ml) was added 1,3-dichloro-1,1,3,3- tetraisopropyldisiloxane7 (550 mg, 1.75 mmol), and the mixture was stirred for 4 h at ambient temperature with... O O + NH 3 O NH O O Acylation of Amines by Anhydrides: Amino-de-acyloxy-substitution 2014 Waters Corporation 20

21 Combine Procedure and Data Entry Using Electronic Forms Procedure Data Entry 2014 Waters Corporation 21

22 Simple Devices Balance Integration 2014 Waters Corporation 22

23 Test Preparation and Specifications Test Documentation Transferred from ERP Scanned Bar Codes 2014 Waters Corporation 23

24 NuGenesis 8 - Workflow Management Defined Workflow & Easy Review 2014 Waters Corporation 24

25 Integrated Supporting Inventory Instrument Standards Reagents Supporting Document 2014 Waters Corporation 25

26 Inventories 2014 Waters Corporation 26

27 NuGenesis Lab Management System 2014 Waters Corporation 27

28 My Work Portal User Centric Access Lab Manager Needs overview about the status of the work Assign tests to analysts Needs overview entire request context Review test documents Approve test requests Analyst Find all pending tests that relevant for them Calibrate instruments Run and document the actual tests Check in/out samples Print sample labels 2014 Waters Corporation 28

29 NuGenesis 8 Sample Management (Requests) 2014 Waters Corporation 29

30 NuGenesis 8 Sample Management (Tests) 2014 Waters Corporation 30

31 NuGenesis 8 Sample Management (Samples) 2014 Waters Corporation 31

32 Review-By-Exception Result correct? Result not modified? OOS? Who is responsible? Result signed? Reagents fit-for-use? Instruments fit-for-use? 2014 Waters Corporation 32

33 NuGenesis 8 available interfaces NuGenesis 8 SAP-QM interface Providing a bi-directional SAP certified interface to minimize transcription errors through automation of information transfer from SAP-QM NuGenesis 8 SDMS interface to ELN Support of external third party laboratories data and direct access to file and printed information within NuGenesis ELN and Sample Management Support of simple devices Direct interface to small laboratory devices such as balances and ph meters and LabX software NuGenesis 8 interface to Empower Create sample sets, access, review and process data within Empower data within NuGenesis 2014 Waters Corporation 33

34 NuGenesis Lab Management System What s New: 2014 Waters Corporation 34

35 Stability Workflow 2014 Waters Corporation 35

36 NuGenesis Lab Management System 2014 Waters Corporation 36

37 Integration with External Labs: Web Interface Account Top Add Review Quickly level samples status check settings view one of for the all by Notifications samples one Dashboard or import a list 2014 Waters Corporation 37

38 NuGenesis Lab Management System 2014 Waters Corporation 38

39 Connecting the Laboratory to Business 2014 Waters Corporation 39

40 NuGenesis Lab Management System LIMS Capabilities without the Complexities 2014 Waters Corporation 40

41 2014 Waters Corporation 41

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