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

    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

    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

    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?

    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

    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.

  • Harmonization Horrors: When Quality System Alignment Goes Wrong

    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.

  • Best Practices In Environmental Monitoring Sampling — Transportation & Analysis

    The process of establishing a defendable environmental monitoring (EM) sampling plan during performance qualification can be broken into six phases. This article discusses the final two phases.

  • Sampling Preparation & Execution Best Practices For Environmental Monitoring

    The process of establishing a defendable environmental monitoring (EM) sampling plan during performance qualification of a new facility can be broken into six phases. This article will discuss the sampling preparation phase and sampling execution phase.

  • 3 Prerequisites To Establishing An Environmental Monitoring Sampling Plan

    This article is the first in a three-part series describing an engineering approach to establishing an environmental sampling plan for a new pharmaceutical or biopharmaceutical manufacturing facility. The series assume the facility has just been built and no manufacturing of batches have been run.

  • 7 Surefire Ways To Motivate A Life Science Consultant

    Companies in the pharma industry are increasingly hiring consultants to meet the objectives of small to large capital projects. It's important that companies motivate their consultants to their maximum abilities


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 and connect with him on LinkedIn (