Articles by Allan Marinelli

1. 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.

2. 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.

3. 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.

4. Harmonization Horrors: When Quality System Alignment Goes Wrong 3/6/2020

   This article is the first in a two-part series explaining how to successfully harmonize disparate quality systems when two companies merge. Here in Part 1, we will focus on what not to do when reconciling two quality systems, providing real-life examples — drawn from the author’s experiences — from each phase of QMS harmonization.

5. Initial Engagement With A Life Science Consultant: Pitfalls & Best Practices 5/12/2017

   Inadequate 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.