1. Michael S. Zachowski, Robert D. Walla Astrix Technology Group 1090 King Georges Post Rd Edison, NJ 08837 A Successful Approach to a LIMS Upgrade In A Public Wastewater Utility Laboratory

2. Abstract Undertaking a Laboratory Information Management System (LIMS) upgrade takes considerable resources that are often underestimated by the client. In addition to the obvious license and support costs, most commercial off the shelf (COTS) products will require customization and/or configuration to meet a client’s specific requirements and work flows. If these are not documented and compared to the base functionality of the COTS LIMS prior to the installation, it is unlikely that adequate resources will be allocated and the project will fall short of its objectives.

3. Abstract This paper will present a case study of a LIMS assessment and upgrade in a public sector wastewater utility laboratory network. The client had an existing COTS LIMS that was no longer supported by the manufacturer and did not meet the ever- increasing needs of the user. In order to successfully upgrade to a new COTS LIMS product, requirements (functional, technical, business) were collected, segmented and prioritized. Use case scenarios were created and incorporated with the requirements into a system specification. The specification will be provided to pre- qualified potential COTS LIMS vendors via a Request for Proposal. After short listing, vendors will be required to perform an onsite demonstration using Astrix supplied demonstration scripts. This approach will provide the client with a better assurance that the selected product will meet the organizational requirements as defined in the system specification.

4. Utility LIMS Upgrade Project Objectives Project Objectives  Purchase Of a COTS LIMS  Implement At Multiple Locations  Integration Of Analytical Instruments  Interface With Existing Data Systems

5. Stakeholder Groups  Laboratory Stakeholders o Sample Receiving o Sample Preparation o Organic Analysis o Metals o Wet Chemistry o Process Control o Biology o Microbiology o Research Group

6. Stakeholder Groups  Non-Laboratory Stakeholders o Quality Assurance o Information Technology o Plant Operations o Ocean Assessment Group o Sampling Group o Lab Management o Regulatory Reporting o Industrial Waste o Monitoring Group

7. Existing Utility System  Plant Operations Database  Toxicity Database  Industrial Waste Pretreatment Information Management System (PIMS)  Enterprise Reporting System

8. “Implementing An Information Management System In A Laboratory Is Like Changing The Tires On A Car Traveling 100 mph” — Author Unknown

9. LIMS Risk Components  60% of IT Projects Are Cancelled Prior To Implementation  Many Systems Never Get Implemented Due To Functional, Time and Budget Constraints  Customization And Integration Requirements Underestimated  Unrealistic Schedule And Budget Estimates  Risk Management Plan Not Well Established  No Formal Process In Place to Select and Implement LIMS

10. Astrix Technology Process Approach  Business Case Preparation  Collect and Organize User Requirements  Development of Functional Specification  Request For Proposal  Evaluation of Vendor Responses (GAP Analysis)  Configuration/Customization/Integration  Validation And Testing  Life Cycle Planning and Maintenance

11.  Onsite Requirements Meetings  Include All Stakeholder Groups  User Focus Groups  Story Boarding Requirements Analysis

12.  Collect Detailed User Requirements  Iterative Process  Segment and Prioritize o Priority 1 – Critical To Work Process o Priority 2 – Improves Work Process o Priority 3 – Nice To Have  Decompose To Level 2-3 Requirements Analysis

13. Requirement Types  Functional Requirements  Technical Requirements  Security Requirements  Regulatory Requirements  Business Requirements

14. System Specifications  Description Of Processes and Procedures  System Requirements  Process Flow Diagrams  Suggested Workflow Changes (if applicable)  Interface Design  Report Design  System Architecture  System Topology  Security Model  Standards and Tools

15. LIMS Selection Protocol  “Roadmap” Of the Selection and Evaluation Process  Description Of Each Phase  Define Roles and Responsibilities  Evaluation Criteria  Project Plan

16.  Generate Request For Proposal (RFP)  Distribution To Pre-Qualified Vendors  Analysis of Vendor Responses  Shortlist Vendors  Vendor Demonstrations  Demonstration Evaluation  GAP Analysis  Identify GAP’s That Are Showstoppers  GAP Option Analysis  Cost Analysis and Purchase Vendor Evaluation and Selection Process

17. Request For Proposal  Developed From System Specifications  Sent To Pre-Qualified Vendors  Provide Information on Company, Product and Services  Develop Vendor Shortlist

18. Request For Proposal Components  Business Overview  Organizational Structure  Work Process Descriptions  Process Flow Diagrams  Requirements Matrix  Vendor Response Forms

19. Proposal Evaluation  Requirement Priority/Response Matrix Evaluation  Conformance To Current Workflow  Architecture/Topology Compatibility  Company Profile o Response To Solicitation o Industry Experience o References o Support Services  Cost Analysis

20. Product Demonstration  Demonstrate How System Conforms To Requirements and Workflows  Not A Sales Demonstration  Standardize Demonstration Using Demonstration Scripts o Outline Tasks To Be Performed o Standard Demonstration Data

21. Demonstration Evaluation  Conformance To Test Scripts  Scoring Criteria  Conforms  Workaround Available  Non-Conformance

22. GAP Analysis  Evaluate GAPS  Prioritize GAP  Options Analysis o Specifications o Cost Analysis

23. Vendor Recommendation  Results Of Product Demonstration  GAP Analysis Results  Cost Analysis

24. LIMS Purchase  Contract Negotiations  Payment Schedule  Source Code Escrow Agreement  Maintenance Agreement  Warrantee

25. Benefits Of A Systematic Approach  Capture All User Requirements  Assures that the LIMS is selected based on Requirements not features  Consistent evaluation criteria applied to all products  Reduces the risk associated with the purchase of a LIMS

26. For More Information, contact: Astrix Technology Group 1090 King Georges Post Rd Suite 604 Edison, NJ 08837 732.661.0400 www.astrixsoftware.com