ARTICLES BY ALLAN MARINELLI

• Computer Systems Validation Pitfalls, Part 4: Inattention To Details

  1/24/2025

  The 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.

• Agile Software Development In Bio/Pharma & Medical Devices, Part 3

  7/25/2023

  Computer 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.

• Lessons From An Outsourced Validation Project That Came Off The Rails

  7/24/2020

  I was recently hired by a sponsor company to support initiatives related to computer system, IT validation, and automation system validation. This article discusses my experiences and perspectives on this engagement, including best practices and lessons learned that other life sciences sponsor companies can apply in their interactions with their consultants.

• A Real-World Consulting Calamity — 6 Ways It Could Have Been Avoided

  6/15/2020

  Some leaders in the pharma, biopharma, and med device industries believe hiring consultants is quicker and more efficient than hiring a full-time employee. Does this thinking fail to factor in the investment required for thorough recruiting and training to ensure a successful engagement?

• Working With Two Consultants On One QMS Overhaul: What Could Go Wrong?

  5/18/2020

  Some companies in the life sciences mistakenly assume that if they hire multiple consulting firms to establish, manage, or overhaul a quality management system, it will inevitably result in an automatic licensure of their new blockbuster product at a low service cost. This article will discuss just such a scenario. 

• Harmonious Harmonization: How To Get Quality System Alignment Right

  4/8/2020

  This article is the second in a two-part series explaining how to successfully harmonize disparate quality systems when two companies combine. Part 1 shared horror stories — drawn from the author’s experiences — illustrating what NOT to do during each phase of QMS harmonization. Here in Part 2, we look at case studies in which companies got it right, bringing together parallel quality systems in a way that increased the probability of success.