QV360 Overview

Introducing QV360: Excellence in Hands-On National and International Consultation Services

Founded in 2011 by Allan Marinelli, QV360 emerged from his remarkable 30 years of direct experience across a variety of industries. Carrying the legacy of exceeding client expectations, our mission is to continue providing top-tier consulting services, setting us apart with a 90% project extension rate due to our unmatched capabilities in delivering quality results within tight deadlines.
We specialize in comprehensive, hands-on national and international consultation, catering to sectors such as pharmaceuticals, biopharmaceuticals, medical devices (Class 1, 2, 3), vaccines, cell/gene therapies, biotechnologies, and the food/beverage industry.
Our Core Expertise
  • We bring deep hands-on knowledge in Computerized Systems Validations (CSV), including manufacturing/laboratory systems, software assurance, and AI/ML software validation across GxP environments.
  • Our services encompass key regulatory and operational systems under stringent compliance with FDA, EMA, and other international regulations.
Advanced Consultation Services
  • We offer practical solutions in Commissioning, Qualification, and Validation (CQV), including writing User Requirement Specifications (URS), Design Specifications (DS), Functional Specifications (FS), Validation Plans (VP), Validation Protocols, executing all of the Validation deliverables, writing Final Reports and Release Memos to Productions as part of the Turnover/Handover Packages. Moreover, as necessitated, we also generate CAPAs, Change Controls, Deviations and adhere to the clients’ Quality Management Systems.
  • Our expertise extends to specialized validations such as equipment, process, cleaning, and computer/laboratory systems, alongside AI-driven software implementations like Veeva and more.
  • At QV360, leadership in Quality Assurance (QA), project management, and science risk-based strategies is given, utilizing state-of-the-art methodologies like ASTM-E2500, GAMP 5 Edition 2, SDLC, Agile, and ICH Q9.
Contributions and Leadership
  • Proud contributors to ISPE baseline GAMP and engineering manuals, influencing industry standards through proactive engagement.
  • We deliver leadership in CSV/IT/CQV, and environmental monitoring etc for various systems, including Bioreactors, Centrifuges, and MES, overseeing all phases from pre-execution to post-execution.
  • Our team manages comprehensive aspects of QA, compliance, remediations, Quality Operations (QO), Quality Engineering (QE), and more by ensuring all systems meet both national and international industry standards

Our Services and Specializations

Our consultancy service thrives on three core pillars:
Expert Guidance in CQV: Leading projects in commissioning qualification validation (CQV) for manufacturing systems including manufacturing execution systems, environmental monitoring systems, and Laboratory systems.
Innovative Solutions in CSV, CSA (Computer Software Assurance) and QA: From any computerized systems including manufacturing/laboratory systems, we bring forward-thinking solutions to our clients, ensuring regulatory compliance and operational excellence.
Strategic Consultations Across Industries: With a global footprint, QV360 offers specialized consultation in operational systems, compliance, remediation, and more, tailored to the unique needs of the pharmaceutical, biotechnological, and food/beverage industries.

A Global Presence

Registered in Stateline, Nevada, QV360 prides itself on its flexibility and global reach, from Boston to California and Europe to Asia. Our journey began with our first client, Harvey Nash IT in Belgium/France, where we provided exceptional quality assurance consultation services. This project set the tone for our commitment to positively impacting the industry and served as a cornerstone of our international consultancy.
We are more than consultants; we are mentors, strategists, and partners in your success. Welcome to QV360 - where excellence is not just promised but delivered.

Allan Marinelli: The Expert Behind QV360

At the helm of QV360 is Allan Marinelli, the visionary Founder and President. Marinelli's extensive experience spans across critical areas such as computerized systems validations (CSV), quality assurance engineering, compliance, and validation roles adhering to global regulations. His knowledge encompasses advanced technology applications like artificial intelligence software validation and offers strategic expertise in project management methodologies and quality management systems.
Allan’s Synopsis

Peer-Reviewed Publications

Allan Marinelli's notable contributions include 15 peer-reviewed publications with the Institute of Validation Technology Network, now part of BioProcess International as of the 4th quarter of 2022, across various esteemed platforms. He has currently published 134 cumulative publications and climbing.
  • Pharmaceutical Online: 22 publications
  • Life Science Leader Online: 7 publications
  • Outsourced Pharma Online: 22 publications
  • BioProcessing Online: 23 publications
  • Med Device Online: 12 publications
  • Biosimilar Development Online: 12 publications
  • Cell and Gene Online: 11 publication
  • Laboratory Network Online: 2 publications
  • Drug Delivery Online: 3 publications
Three (3) Peer Reviewed Publications with Parenteral Drug Association (PDA) Books
Latest eBook from Allan Marinelli

Online Publication Subsidiaries of Vert Markets Publishers

All online subsidiaries associated with Vert Markets Publishers distribute the same publication topics or subjects multiple times, without copyright violations, featuring Allan Marinelli as a published author representing QV360.
(1) Drug Delivery Leader
(2) Pharmaceutical Online
(3) Life Science Leader Online
(4) Out Sourced Pharma Online
(5) Bioprocessing Online
(6) Med Device Online
(7) Biosimilar Development Online
(8) Cell and Gene Online
(9) Laboratory Network Online
“Computer Systems Validation Pitfalls, Part 1: Methodology Violations”
“Computer Systems Validation Pitfalls, Part 2: Misinterpretations & Inefficiencies”
“Computer Systems Validation Pitfalls, Part 3: Execution Inconsistencies”
Computer Systems Validation Pitfalls, Part 4: Inattention To Details
“Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 1”
“Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 2”
“Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 3”
American Society for Quality (ASQ) in the Quality Progress
“Agile Software Development in Bio/Pharma & Medical Devices, Part 1”
“Agile Software Development in Bio/Pharma & Medical Devices, Part 2”
“Agile Software Development in Bio/Pharma & Medical Devices, Part 3”
“Pharma 4.0 Software Methodologies in Biopharma & Medical Devices”
“Lessons Learned from An Outsourced Validation Project That Came Off the Rails”
“A Real-World Consulting Calamity — 6 Ways It Could Have Been Avoided”
“Working with Two Consultants on One QMS Overhaul: What Could Go Wrong?”
“Harmonious Harmonization: How to Get Quality System Alignment Right”
“Harmonization Horrors: When Quality System Alignment Goes Wrong”
“Best Practices in Environmental Monitoring Sampling — Transportation & Analysis”
“Sampling Preparation & Execution Best Practices for Environmental Monitoring”
“3 Prerequisites to Establishing an Environmental Monitoring Sampling Plan”
“7 Surefire Ways to Motivate A Life Science Consultant”
“Initial Engagement with A Life Science Consultant: Common Pitfalls & Best Practices”
“A Quality Validation Risk Management Approach to Establishing Sampling Plans”
“How to Hire A Qualified Contingent Recruiter”
“5 Steps to Set Effective Goals for A Life Science Consultant”
"Procedure for Spray Coverage Testing with Riboflavin" in Cleaning and Cleaning Validation, Volume 2: Applications of Basics and Principles
Published by PDA and DHI Publishing, Spring 2013
Allan Marinelli was also involved as a "Peer Reviewer" of submitted manuscripts by unknown authors on behalf of the International Society for Pharmaceutical Engineering (ISPE) prior to formal publications for the following articles, engineering baselines, and computerized systems baselines indicated below:
ISPE Good Practice Guide
“Good eClinical Practice 2nd Edition: Validation and Compliance of Computerized GCP Systems and Data 2nd Edition”February 2024
ISPE Good Practice Guide
“Validation 4.0 Draft 1 for Industry Review” September 2024
ISPE Good Practice Guide
“Digital Validation Draft 1 for Industry Review” September 2024
ISPE Good Practice Guide
“Ozone Sanitization of Pharmaceutical Water Systems 2nd Edition Draft 1 for Industry Review” April 2024
ISPE Good Practice Guide
“Heating, Ventilation, and Air Conditioning (HVAC) 2nd Edition Draft 1 for Industry Review” April 2024
ISPE Guide
“Quality Risk Management Best Practice Draft 1 for Industry Review” July 2024
Article
“Final Preparation of Advanced Therapy Medicinal Products at Point of Care — Call for Harmonization 2024”
Article
“Industry Perspectives on Practical Application of Platform Analytical Procedures 2024”
Article
“Revolutionizing Pharmaceutical Production: The Power of Fleet Management in Distributed Manufacturing 2024”
ISPE Guide
“Advance Therapy Medicinal Products (ATMP)-AAV Comparability and Lifecycle Management Draft 1 for Industry Review” January 2023
ISPE Baseline Guide
“Biopharmaceutical Manufacturing Facilities 3rd Edition Draft for Industry Review” February 2023
ISPE Good Practice Guide
“Process Gases Draft for Industry Review” April 2023
ISPE Baseline Guide
“Validation 4.0 Draft 1 for Industry Review” September 2024
ISPE Good Practice Guide
“Unique Glass Primary Containers Identification in Pharmaceutical Fill and Finish Operations: Best Practice for Achieving Product Traceability, Process Visibility, and Quality Draft for Industry Review” July 2023
Article
“Evolving China Regulatory system in alignment with ICH 2023”
Article
“Manufacture of medicines: contamination, regulation and strategies 2022”
Article
“Remote Acceptance Testing of Automation Projects in Industry: A Qualitative Field Study”
eBook

What Clients Say About Allan Marinelli

Allan has received 27 recommendations on LinkedIn from peers, competitors, and direct management.
  • "I am pleased to recommend Allan Marinelli for his exceptional technical leadership and expertise in quality assurance and validation. During his time as a Corporate Technical Quality Assurance Program Expert Consultant, Allan demonstrated outstanding skills in QA, CSV/IT, and CQV, excelling under U.S. FDA and Canadian HPFBI regulations.
    His ability to manage complex compliance tasks, from designing SDLC documents to reviewing CAPAs, change controls, and computerized systems like Microsoft Dynamics 365 and Thermo Fisher LIMS™, was truly impressive. Allan’s knowledge and professionalism are a testament to his capability as a consultant.
    He would be an invaluable asset to any team."
    Dan Peretz
    Quality Systems ConsultantNovember 24, 2024
  • "This man is a trove of deep knowledge and wisdom. His well rounded years of experience make him and asset in countless environments and situations. His ability to clearly and thoroughly articulate himself make him a reliable high level contributor to any organization and his approach is always amicable and altruistic."
    Mauro Lomonaco
    Biopharceuticals Process EngineerJuly 13, 2024
  • "Allan is very talented, energetic, and driven by high expectations and goals. He has proven his skills in problem solving, motivation and collaboration along with his knowledge of the biotech and pharmaceutical industry allow him to take on any challenge and meet or exceed expectations. I would work with Allan on any project at any time."
    Russell Regan
    President RJR Technical Services, LLCApril 18, 2022
  • "I had the pleasure of working with Allan on a comprehensive CSV remediation project for a larger multinational manufacturer. Allan is enormously qualified and an adept and agile thinker. His data analytical skills are impeccable as well as his quality Management skills. Allan is a team player, always working toward the safety and efficacy of the patient or end user on every project he works on. Allan also has a tremendous work ethic and I would enjoy working with Allan again.
    Sincerely,
    Cindi Lambert"
    Cynthia Lambert
    Senior Medical Technology Consultant at ProPharma GroupApril 5, 2022
  • "I have known Allan Marinelli since 2011. We were colleagues in 2011 in Boston. Allan has done validation assignments for multiple clients in the US. Allan has performed validation tasks in China, Korea, India, Belgium. Allan’s validation range extends to multiple categories of validation. He possesses excellent skills in 21 CFR Part 11(Electronic Signatures), Electronic records and Data Integrity and gap assessment.Allan has considerable expertise in Quality Operation functions, Change Controls, and mentoring/coaching recipients on how to properly author CAPA, Deviations, Change Controls, Quality Events.
    He has helped many fellow Validation professionals is securing validation assignments. He has mentored numerous people in understanding validation life cycle and deliverables."
    Pete Thomas
    Senior Computer System Validation EngineerDecember 13, 2021
  • “Allan Marinelli has represented “Harvey Nash” as a Senior Quality Assurance Engineering Management Consultant in Europe since 2009 and I highly recommend him to any potential employers who want reliable results in an efficient manner. Allan Marinelli is highly motivated and functions on a high ethical standard. Anyone who truly knows Allan Marinelli will be happy to do business with"
    Giuseppe Montante
    Account Manager, Harvey Nash IT Consulting N.V [Belgium][Harvey Nash has hired him more than once since 2009.]
    “Allan Marinelli has worked for 2 months as a newly created position at GSK [Belgium] titled “Quality Assurance Coach Specialist” in which he was directly reporting to me. Allan demonstrated that he masters the Validation and Quality Assurance expertise during his work at GSK from May to June 2011"
    Guy Godeau
    QA Director at GSK-BIO [Wavre/Rixensart Belgium
  • “I have worked professionally with Allan Marinelli from 1998 through 2002 at Raylo Chemicals when I was employed there as the Pilot Plant Manager / Project Champion. Allan was originally brought into our organization to aid in the qualification and validation efforts for a new multimillion-dollar commercial plant being built to expand our capacity by 10 fold. ln November of 2001 I had the opportunity to work with Allan when he was assigned to our project group to oversee the qualification and validation efforts required for the construction and system implementation for our new Oligonucleotide Laboratory. From November 2001 through to July 2002 I was able to observe Allan's work ethic, experience and professionalism with respect to the construction project, in which I was responsible for. He worked diligently and patiently to address problems and work through issues with the project team and suppliers- Additional effort was noted regularly with teaching and training of individuals within the project group in the areas that he was known to be strong in, Allan is meticulous and pays a great deal of attention to detail to understand systems completely. I found it to be an opportunity to have someone with Allan's background and experience to facilitate the qualification and validation efforts for our new facility. From 2002 onwards, I have kept in contact with Allan and feel that he has built a wealth of valuable experience that has application in a variety of industries. I invite you to contact myself, Doug Drabble for further reference or inquiry at 336-923-5225”
    Doug Drabble
    Director of BioNetwork and Life Sciences InitiativesJanuary 30, 2012
  • "Allan worked in the Celltrion QC department in 2005/2006 [South Korea] as a Senior Validation Engineering / Consultant for 1.25 years to help us establish the QC Department, and provided for guidance and expertise in instrument and lab equipment I,O,PQ and operational SOPs. I would like to recognize his contributions to Celltrion. He was a top-notch scientist and validation engineer who additionally provided instrument validation concept training, execution and also validation maintenance. As a statement to these contributions, the company received no 483 observation in the QC labs as part of the new facility FDA, PAI inspection. Allan's top-quality performer, creative and integrity.”
    Rusty Kutny
    [Formally Senior Director of Quality/Quality Control at Celltrion, South Korea]RK Quality Consulting LLCrkutny1@verizon.netFeb 20, 2012
  • “In 2004 at the Los Angeles, California plant for Baxter, I [Project Engineer at Baxter] have worked with Allan Marinelli who was representing Validation Technology Incorporated [VTI) as a Senior Validation Engineer/Scientist in the same project titled “Utilities Validation, Reverse Osmosis, and Water for Injection System]. I have observed his excellent technical skills, hands-on experiences, and many of his recommendations resulted in increasing the efficiency of the project by eliminating the necessary hurdles/show-stoppers that was preventing the compressed schedule from moving forward in a timely manner. In addition, he has authored the Utilities Validation protocols, re-redlined many of the drawings [Lots of red-lining] that were previously incorrectly representing field conditions, executed test-scripts/protocols, and supported the deviation team lead that came from Germany Baxter [That was brought in to ensure quality objectives are meet, and alignment with upper management strategies, meeting a compressed schedule].”
    Zoran Sovljanski
    Project Manager, BW Design GroupZSovljanski@hotmail.comCell: 858-731-7333May 26, 2014