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Research ArticleTechnology/Application

A Systematic Approach for the Evaluation, Validation, and Implementation of Automated Colony Counting Systems

Sven Deutschmann, Bill Carpenter, Caroline Duignan, Chris Knutsen, Joanny Salvas, Lisa Wysocki, Lucile Plourde, Lynn Johnson and Wolfgang Eder
PDA Journal of Pharmaceutical Science and Technology November 2022, 76 (6) 509-526; DOI: https://doi.org/10.5731/pdajpst.2021.012646
Sven Deutschmann
1Roche Diagnostics GmbH, Penzberg, Germany;
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Bill Carpenter
2Biogen Inc., RTP, NC;
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Caroline Duignan
3GlaxoSmithKline, GSK Medicines Research Centre, Stevenage, United Kingdom;
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Chris Knutsen
4Bristol-Myers Squibb, New Brunswick, NJ;
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Joanny Salvas
5Pfizer, Kirkland, Canada;
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Lisa Wysocki
6GlaxoSmithKline, Collegeville, PA;
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Lucile Plourde
7Sanofi Pasteur, Marcy-l’Etoile, France;
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Lynn Johnson
8Takeda, Lexington, MA; and
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Wolfgang Eder
9Roche Diagnostics GmbH, Penzberg, Germany
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PDA Journal of Pharmaceutical Science and Technology: 76 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 76, Issue 6
November/December 2022
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A Systematic Approach for the Evaluation, Validation, and Implementation of Automated Colony Counting Systems
Sven Deutschmann, Bill Carpenter, Caroline Duignan, Chris Knutsen, Joanny Salvas, Lisa Wysocki, Lucile Plourde, Lynn Johnson, Wolfgang Eder
PDA Journal of Pharmaceutical Science and Technology Nov 2022, 76 (6) 509-526; DOI: 10.5731/pdajpst.2021.012646
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  • Article
    • Abstract
    • Introduction
    • Approach to Adoption of Automated Colony Counting (ACC) Systems: Applying a 9-Step Framework
    • Step 1: Identify Operational/Business Need
    • Step 2: Define the Application
    • Step 3: Assess Requirements
    • Step 4: Compare Options and Technologies—Landscaping and Candidate(s) Selection
    • Step 5: Develop a Business Case: Technical, Quality and Business Evaluation and Justification
    • Step 6: Perform Proof-of-Concept Studies/Feasibility Studies/Prevalidation Studies
    • Step 7: Validate at Pilot or Primary Site
    • Step 8: Deploy Global/Company-Wide Qualification of Additional Laboratories
    • Step 9: Define Regulatory Filings and Implementation Strategy
    • Disclaimer
    • Conflicts of Interest Declaration
    • Acknowledgements
    • Footnotes
    • References
  • Figures & Data
  • References
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  • PDF

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A Systematic Approach for the Evaluation, Validation, and Implementation of Automated Colony Counting Systems
Sven Deutschmann, Bill Carpenter, Caroline Duignan, Chris Knutsen, Joanny Salvas, Lisa Wysocki, Lucile Plourde, Lynn Johnson, Wolfgang Eder
PDA Journal of Pharmaceutical Science and Technology Nov 2022, 76 (6) 509-526; DOI: 10.5731/pdajpst.2021.012646

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