Advantages of an Enterprise Laboratory Software Platform Nick Townsend, Director Life-Sciences, LabWare Europe. Results Count

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1 Advantages of an Enterprise Laboratory Software Platform Nick Townsend, Director Life-Sciences, LabWare Europe

2 Advantages of an Enterprise Laboratory Software Platform Many of you in the room today, will be considering introducing laboratory software to automate lab processes, or considering replacing older lab software, or running existing systems (and perhaps considering expanding or upgrading) This short talk will Review the landscape of the laboratory software market today Explain the pros and cons of different approaches to implementing a laboratory software solution LabWare [2]

3 Laboratory software used to be... Chromatography Data Systems (CDS) Instrument workstation applications Laboratory Information Management Systems (LIMS) A variety of home-built applications Spreadsheets LabWare [3]

4 In the last 5-10 years, the situation has changed Chromatography Data Systems (CDS) Instrument workstation applications Laboratory Information Management Systems (LIMS) Electronic Lab Notebook (ELN) Scientific Data Management Systems (SDMS) A variety of home-built applications Spreadsheets LabWare [4]

5 Today Compared to 10 years ago There are more options The products are more sophisticated Different vendors There is overlap between products Plenty of opportunity for confusion (and mistakes) LabWare [5]

6 But the challenges are still familiar How to meet end-user requirements (an ever expanding list) The need to deliver a compliant solution Delivering as much as possible with a limited budget Controlling scope Efficient implementation and Validation Demonstrating a return on investment Reducing support overheads Minimising custom (home built) applications LabWare [6]

7 What does what? 2011 The common view LIMS - Provides structure, workflow automation and management functionality ELN Provides flexibility, processing of unstructured data, IP protection SDMS Provides long term archival of (raw) data files LIMS ELN SDMS LabWare [7]

8 LIMS v ELN v SDMS LIMS ELN LabWare [8]

9 Do I really need all of these applications? Some people would argue Yes However, in the real world Budgets are limited Few people are able to start with a clean sheet It s not always easy to switch off legacy applications. A more practical, phased approach (is usually) required LabWare [9]

10 ..and Increasing overlap & duplication of functionality LIMS ELN? SDMS..so what is the best strategy? LabWare [10]

11 Strategy 1 Buy these applications gradually (from different vendors) Pro s Perhaps can spread the cost over a number of years Projects may be more self contained, easier to deliver You perhaps get the best software available at the time. Con s The Lab Informatics landscape is constantly evolving (new vendors, new capabilities etc) User requirements constantly evolving and their perceptions of what s good and bad ( Who decided to buy this! ) Multiple selection processes (cost & time) How to connect all the applications together How to upgrade them and keep them all in Sync LabWare [11]

12 Connecting A to B to C - Challenges How will it be achieved? SQL? File transfer? WebServices? Will the data transfer format remain the same over time? How will upgrades to A, B or C affect the interface? Will these applications coincide on the same server? Same O/S? Same database version? How will the end user interact with the different applications to do their job? Will data be duplicated? Will it get out of sync. How will the interfaces be validated? LabWare [12]

13 Strategy 2 Implement only one of these applications Pro s Save s money May automate > 60% of your requirements Simpler/quicker project Easier to support and maintain Upgrades may bring new functionality Con s May lose business (and competitive) benefits Running in a partially automated mode with paper/spreadsheets etc. may be a compliance risk End user satisfaction reduced ( and don t forget perceptions) LabWare [13]

14 Strategy 3 Implement all in one application Pro s Seamless integration Reduced support cost (one application only) More straightforward upgrades (everything in Sync ) Phased projects still possible, i.e. Switch-on new functions only when you are ready No competitor wars Con s Putting all your eggs in one basket What happens if the vendor goes out of business? Are you getting the best LIMS, ELN and SDMS? LabWare [14]

15 Strategy 3 what I mean One application Seamlessly integrated No redundancy The testing/review lifecycle is completely integrated within a single application and database [15]

16 Strategy 3 what I do not mean Buying loosely integrated discrete applications from one vendor The marketing and vision sounds good! but will the vision ever deliver a truly seamlessly integrated solution How will this develop over time? Review lessons from history [16]

17 One, seamlessly integrated laboratory platform Single sign-on, seamless interface for the end-user. Common security system (and 21 CFR Part 11 controls) Re-use of many (all) LIMS functions in ELN Shared instrument data acquisition system Common database shared auditing, querying and reporting tools No synchronization worries. No duplication of data Common configuration tools & system management Shared (existing) hardware infrastructure Common support & upgrade process Common commercial contract (already in place) No future compatibility worries...and much more.

18 One, seamlessly integrated laboratory platform Functional advantages Shared (single) user login Shared user profiles functional privileges and other user characteristics are shared with LIMS Common look and feel to the interface, with full support for multiple languages. Shared access to LIMS tables such as the Analysis table, units, products, product specifications, calculations, instruments, standards and reagents, inventory management etc. Shared use of Sample, Test and Result ID s between LIMS and ELN. Shared use of the LIMS Review and Approval management system Shared use of LIMS alerting system and Investigation/OOS management system. ELN can react in real time to OOS results e.g. by immediately issuing LIMS Alerts and initiating repeat analyses using LIMS Analysis rules. Shared access to application modules such as Stability Manager. In principle, ELN can seamlessly integrate with almost any LIMS module. Shared instrument data acquisition system Shared labelling and barcode systems Shared query and reporting tools. It is also straightforward to open an ELN procedure from LIMS, or a LIMS object from ELN. Shared use of trending and charting tools Shared audit trail, e-sig and other compliance tools. [18]

19 One, seamlessly integrated laboratory platform Technical Advantages: Shared configuration tools, including macro language for advanced configuration Shared use of Web-Services for integration Shared server infrastructure (including development, training and qualification environments) Shared database (and database independence see following section) Common upgrade process Common deployment technique, i.e. ELN is delivered within the same interface as LIMS Non-technical/Commercial Advantages: Shared support line and support services ELN and LIMS controlled by the same Quality System (one vendor audit!) ELN and LIMS can be included under the same commercial agreement (contract). Shared user-group meeting for ELN and LIMS [19]

20 The value of a single, integrated LIMS & ELN software platform Single sign-on, seamless interface for the end-user. Re-use of many (all) LIMS functions in ELN Cost Savings Shared instrument data acquisition system Common database shared auditing, querying and reporting tools No synchronization worries The Industry trend is to implement Common configuration tools & system management FEWER, not more software Shared (existing) hardware infrastructure Common support & upgrade process applications. Common commercial contract (already in place) No future compatibility worries...and much more.

21 Road Map to a Enterprise Laboratory Platform Incremental functionality, via seamless upgrades Version 1, Version 2 LabWare 2010 Version N

22 In my view... A single, enterprise laboratory software platform (Substantially) eliminates integration issues During the initial implementation Later, when it s time to upgrade Eliminates data redundancy & data synchronization issues Simplifies support, licensing and other commercial aspects Is (substantially) more cost effective Offers the best possible opportunity to grow/evolve over time... LabWare [22]

23 Evaluating your vendor is key... See beyond the marketing messages How well is the software selling (new systems) How profitable is the software product line Is the product being actively developed How stable is the software organisation How committed are the management team etc. etc. LabWare [23]

24 Thank you! LabWare [24]