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New York . West Palm Beach . Boston . Philadelphia . Kansas City . Los Angeles

www.astrixtechgroup.com

Selecting The Proper LIMS A Systematic Approach To Guarantee A Successful

Implementation

Astrix Technology Group

Robert Walla

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Why Do We Need A Systematic Approach To Select A LIMS?

NEMC 2011

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Automobile House

NEMC 2011

Usually Purchased Based On High Level Requirements

Major Life Purchases

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Must Be User Friendly Must Operate On Windows Must Operate On The Internet Must Be Able To Track Samples Must Perform QC Must Generate Reports

NEMC 2011

LIMS High Level Requirements

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Requirements

NEMC 2011

Approximately 100 Commercial LIMS And They All Can Meet Those High Level Requirements

LIMS Operate At The Granular Level Of The Organization

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High Rate Of Failure

NEMC 2011

50% Of All LIMS Initiatives Do Not Get Fully Implemented, Do Not Meet User Expectations Or

Fail Outright.

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Must Be Able To Track Samples

NEMC 2011

LIMS Requirements Decomposition

• Does It Track Split Samples?• How Does It Track Redos?• Does Each Container Have A Unique Number?

• How Does It Handle Broken Bottles?• Can The LIMS Record That the Sample Was Not Received?

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Typical LIMS Evaluation

NEMC 2011

Ask A Colleague Internet Search Attend A Conference Invite Vendor To Perform Demonstration

This Approach Only Addresses High Level Requirements

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LIMS Risk Components

NEMC 2011

Under Estimate Configuration Vague Integration Requirements Data Migration Component Unrealistic Schedule Lack of Sufficient Budget

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Work Process Evaluation and Requirements Analysis

Develop Request for Proposal and Score Results

Vendor Demonstrations and Score Results

NEMC 2011

LIMS Selection Systematic Approach

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NEMC

Interviews• Include All Stakeholder Groups• Segment By Functional Area

Decompose Requirements Prioritize

Work Process And Requirements Analysis

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NEMC 2011

Target System

Sample Analysis

Tune Instrument

Tune Pass?

No

Run Calibration

Calibration Pass?

No

Yes

Yes

Sequence File

Create Control Charts

Pass QC?

Review Data

Yes

No

Print Charts

Calculate Limits

Data Transfer

LIMS

Analyst Notification

Re-AnalyzeSample?

Yes

No

Update Status

Sample Storage

Dispose of Sample?

Discard Sample

Yes

No

Refer To Data Review

Process

Begin Semi-Voa Analysis

or Data Review

Please Describe How Your System Conforms To The Semi-Volatiles Analysis and Data Review Process___________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

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NEMC 2011

Requirements Matrix

Number Description Type Priority StateVendor

Response Comments6 The LIMS should contain a Calendar with scheduling capabilities 1 C

6.1 The calendar should be public to all groups FN 1 F6.2. The system should allow for individual group calendars FN 1 F6.3. The calendar should allow for coordinating/organizing sampling schedules FN 1 F6.4. The calendar should display projects according to their projected collection dateFN 1 F6.5. The calendar should display the project name FN 1 F6.6. The calendar should display the projected number of samples FN 1 F6.7. The calendar should display the analyses method FN 1 F

7 The LIMS must capture Project/permit information 1 C7.1 The system must capture Project/permit name FN 1 F7.2. The system must capture the permit number, if applicable FN 1 F7.3. The system must capture the name of the project manager FN 1 C7.4 The system must capture the contact information FN 1 C

7.1.1. Contact name FN 1 C7.1.2. Contact phone number FN 1 C7.1.3. Contact email (if any) FN 1 C7.1.4. Contact web address (if any) FN 1 C7.1.5. Fax (if any) FN 1 C7.1.6. Cell phone (if any) FN 1 C

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NEMC 2011

RFP Components• Business Overview• Organizational Structure• Work Process Descriptions• Process Flow Diagrams• Requirements Matrix• Vendor Response Forms

Request For Proposal

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NEMC 2010

Conformance To Requirements (Weighted Evaluation)

Industry Experience Company Profile Cost

RFP Evaluation

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NEMC 2011

LIMS RFP Evaluation Score Sheet

Line Section Score

1 Item B: Proposer's Questionnaire, Questions 11, pg. 63 of RFP  

2 Item B: Proposer's Questionnaire, Questions 13, pg. 63 of RFP  

3 Item C: System Requirements Response Form, pgs. 65-156 of RFP  

4 Item D: Process Flows, Sample Receipt, D1, pg. 158 of RFP  

5 Item D: Process Flows, Volatile Analysis, D2, pg. 159 of RFP  

6 Item D: Process Flows, Semi-Volatile Analysis, D3, pg. 160 of RFP  

7 Item D: Process Flows, Air Analysis, D4, pg. 161 of RFP  

8 Item D: Process Flows, Metals Analysis, D5, pg. 162 of RFP  

9 Item D: Process Flows, Wet Chemistry, D6, pg. 163 of RFP  

10 Item D: Process Flows, Toxicity, D7, pg. 164 of RFP  

11 Item D: Process Flows, Microbiology, D8, pg. 165 of RFP  

12 Item D: Process Flows, Ocean Assessment, D9, pg. 166 of RFP  

13 Item D: Process Flows, Process Control, D10, pg. 167 of RFP  

14 Item E: Vendor Product Information, Current Products, Configuration and Migration Path, pgs. 168-169 of RFP  

15 Item E: Vendor Product Information, Support and Updates, pgs. 170-171 of RFP  

16 Item E: Vendor Product Information, System Implementation, pg. 173 of RFP  

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NEMC 2011

Demonstrate How System Conforms To Requirements and Workflows

Not A Sales Demonstration Standardize Demonstration Using Custom

Demonstration Scripts• Vendor and Product Overview• Demonstration Data• Demonstration Tasks

Product Demonstration

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NEMC 2011Functional Business Area: Project Creation Demo Script No.: 2

Description:Demonstrate how to create and modify a project.Demonstrate how to create bottle kits, labels and Chain-of-Custody forms.Demonstrate how to create ad hoc sampling events.

Step Req. # Requirement Description Evaluation Comments

1 N/A Prior to the demonstration date, enter the information described in Section 4.1.

2 4.5 Add a sample location described below to the existing project named “Hyperion NPDES”:Location: Location CClient Contact: Mark ClientComposite Sample Collection Date: 7/13/07 Project Manager: Mas DojiriDate Due: Default TATAdd the same parameters and associated data to this sampling location that have been previously added to the other locations (Aluminum, Beryllium, Cadmium).

3 4.5,4.8,4.9

Modify the schedule of the “Hyperion NPDES” project based on the information below:Location: Location CParameter: MBASSampling Frequency: Monthly

4 1.3 Print a bottle list kit for the “Hyperion NPDES” project.

5 N/A Change the bottle lot numbers to reflect the current lot in the “Hyperion NPDES” project.

6 7.1 Print the bottle labels for the “Hyperion NPDES” project. Labels should include individual bottle tracking information.

7 6 Print the Chain-of-Custody forms for the “Hyperion NPDES” project.

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Demonstration Do’s and Dont’s

NEMC 2011

Schedule Enough Time If You Don’t See it - Ask Keep To The Scripts The Goal Is Not To Trick The Vendor

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Cost Analysis

NEMC 2011

Compare Apples To Apples Licenses Services Support

Cost Should Include All Demonstrated Functionality

Level of Effort Must Make Sense

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NEMC 2011

LIMS Implementations Are High Risk

A Systematic Approach Will Reduce The Risk

Results In The Selection of the Proper LIMS With A realistic Schedule and Budget

Summary

An Experienced Partner Can Assist With Implementing A Systematic Approach

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New York . West Palm Beach . Boston . Philadelphia . Kansas City . Los Angeles

www.astrixtechgroup.com

Questions