ARTICLES BY ALLAN MARINELLI
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![Information technology student coding-GettyImages-1178878544]( "Computer Systems Validation Pitfalls, Part 4: Inattention To Details")
Computer Systems Validation Pitfalls, Part 4: Inattention To Details1/24/2025The authors conclude their 4-part article series on computer systems validation (CSV) pitfalls using real case studies to illustrate points related to inattention to details.
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![AGILE_PART3_revision]( "Agile Software Development In Bio/Pharma & Medical Devices, Part 3")
Agile Software Development In Bio/Pharma & Medical Devices, Part 37/25/2023Computer software/systems validation testing are used to validate software under GxP environments. Parts 1 and 2 of this article series shared Agile methodology with regard to the phases of planning, team structure and collaboration, software architecture, and more. In this final installment, the author discusses software release, configuration and change management, CAPA, and more.
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![business-meeting]( "Initial Engagement With A Life Science Consultant: Pitfalls & Best Practices")
Initial Engagement With A Life Science Consultant: Pitfalls & Best Practices5/12/2017Inadequate communication between the consultant and the client, especially at the initial engagement phase, is often not taken seriously enough or addressed sufficiently on both sides.
Allan Marinelli
Allan Marinelli has over 25 years of global cGMP experience (FDA, EMA, SFDA, KFDA, WHO, etc.). He is currently president/CEO of Quality Validation 360 Inc., providing consultation services to the (bio)pharmaceutical, medical device, and vaccine industries. Marinelli has authored 59 publications, including peer-reviewed papers (Institute of Validation Technology), chapters of PDA books, articles in ASQ journals, online articles (Life Science Leader, Pharmaceutical Online, Bioprocess Online, Outsourced Pharma, etc.). He has provided comments to ISPE’s Baseline Guides and recently conducted reviews of the new ISPE Good Practice Guide drafts on data integrity by design and equipment reliability. You can contact him at amarinelli360@gmail.com and connect with him on LinkedIn (https://www.linkedin.com/in/allanmarinelli/).