Implementation of an Electronic Laboratory Notebook in a CRO Environment. Ronald Shoup AIT Bioscience, LLC 25 May 2010

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1 Implementation of an Electronic Laboratory Notebook in a CRO Environment Ronald Shoup AIT Bioscience, LLC 25 May 2010

2 Greenfield Objectives January 2009: Build a new bioanalytical CRO with a vision unencumbered by legacy constraints. Key goals: Paperless, completely electronic data- no conventional forms or lab notebooks Catching errors in real time Quality audits by exception Sample preparation by robotics LIMS providing instrument control and data acquisition Automated document generation

3 Delivery Targets

4 Perspectives as a CRO Building institutional memory in electronic records We re complicated! (50 companies, not 1) Providing data access to outside reviewers Exporting records for auditors Reconstructability, searchability FDA Part 11 compliance

5 Regulated bioanalysis LC-MS/MS Ligand binding assays (ELISA) Supporting preclinical through late phase clinical studies Not pharma discovery Not toxicology Not GMP analytical

6 Our early perceptions about ELN s: Marketed to share research data across departments Not well organized for regulated bioanalytical CRO environment (but probably could be customized) Some products were GMP-focused (and successful) Process began in April 2009

7 Timelines 2 products evaluated starting June 2009 AIT internal prototype- August-Nov IDBS evaluation- Nov-Dec Purchase commitment- Dec Interviews on user requirements- Jan 2010 QA vendor audit- Feb Final user requirements- March Templates, hierarchy development- ongoing

8 Advantages for AIT with IDBS E-WorkBook Unstructured like a paper lab notebook, but also Structured method management system with controlled forms Hierarchical organization similar to Windows Explorer and prior legacy systems Validated templates for repetitive tasks Business, scientific rules enforced Error prevention during the lab activity Audit by exception Searchability like a web search

9 Typical Paper Lab Notebook Pages

10 E-WorkBook Desktop

11 Method development organized by molecule published papers sources and PO s method development attempts stability data summaries method extraction procedures instrument conditions notes and precautions

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18 Version-controlled Templates for Regulatory Studies

19 Completing an Experiment Based on Templates

20 Digital signatures on sections of experiment

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22 Building Trusted Templates Lifecycle management controlled by hierarchy Primary templates build specific draft templates Testing phase (PQ) according to test plan PQ data stored as electronic experiment (each test point can be saved as a version in the history) QA review, management approve the PQ experiment Template moved to Approved Template folder for use

23 Regulated Study Layout in E- WorkBook Sponsor node > Sponsorspecific entities and studies Study node > Studyspecific entities, including data Only approved templates allowed

24 Simplifying an Overly-complicated Process CLASSIC Get form or notebook Locate the method Document the reference material and balance to be used Weigh material and record Calculate volume for dissolution Label container Document all activities and material in notebook Cut and paste raw data tapes. Pass to 2nd person for review. NEW Login to notebook Select electronic method Scan bar codes of balance, weight set, reference material, diluent. Weigh 2 test weights- ok? Weigh reference material- in range? Add volume of solvent determined by system Print bar code label with all info No reviews Lab work without further documentation!

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26 ELN Workflow for stock solution ELN Reference Stock Workflow

27 No transcription errors Wireless upload of data to ELN

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29 Robotics at Work Sample barcodes read by liquid handler Make calibration standards, aliquot to plates, extract; save logfile

30 Use QC/QA Resources Up Front Instead of After the Fact All ELN templates are validated and controlled. Errors prevented, corrected in real time. Audit by Exception greatly reduces QC review time. Less rework & review means faster turnaround.

31 ELN CRM WATSON Electronic Report Template

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