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- Published online December 2, 2022.
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- previous version (March 16, 2022 - 13:32).
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© PDA, Inc. 2022
Author Information
- Sven Deutschmann1,
- Bill Carpenter2,
- Caroline Duignan3,
- Chris Knutsen4,
- Joanny Salvas5,
- Lisa Wysocki6,
- Lucile Plourde7,
- Lynn Johnson8 and
- Wolfgang Eder9
- 1Roche Diagnostics GmbH, Penzberg, Germany;
- 2Biogen Inc., RTP, NC;
- 3GlaxoSmithKline, GSK Medicines Research Centre, Stevenage, United Kingdom;
- 4Bristol-Myers Squibb, New Brunswick, NJ;
- 5Pfizer, Kirkland, Canada;
- 6GlaxoSmithKline, Collegeville, PA;
- 7Sanofi Pasteur, Marcy-l’Etoile, France;
- 8Takeda, Lexington, MA; and
- 9Roche Diagnostics GmbH, Penzberg, Germany
- *Corresponding Author: Margit Franz-Riethdorf, BioPhorum Operations Group Limited, 5 Westbrook Ct., Sharrowvale Rd., Sheffield, S11 8YZ, United Kingdom. E-mail: margit.franz-riethdorf{at}biophorum.com
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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
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