Architected for Security, Compliance, & Reliability

Trust starts with transparency. Keeping your trust is at the forefront of our platform’s journey.


Connecting you to the latest information on the security, reliability, privacy, and compliance of our software


Rigorously tested, enterprise-level protection with cutting-edge encryption.


Compliant with ISO 27001:2022, SOC 2, and other industry leading standards and regulations.


Best-in-class privacy and data security to protect integral assets.


Consistency and uptime to meet your business demands.


Robust best-practices that ensure optimal system performance.


You’ve got questions, we have answers. Can’t find what you’re looking for? Contact us today!


QbDVision protects your proprietary data with best-in-class security features

  • 256-bit encryption (transit/rest)
  • GAMP5 Level 3 cloud-based software solution with serverless architecture (COTS)
  • Coded with OWASP Top 10 in mind
  • Static application security testing
  • External penetration testing performed at least annually
  • Comprehensive in-house information security management system
QbDVision Trust & Security
QbDVision is a leader in Compliance Security


Proven, industry-leading security compliance

  • Adhering to ISO 27001:2022 standards
  • Established system and organizational controls through SOC 2
  • Continuous compliance monitored by Vanta
  • Compliant with 21 CFR 11, EU Annex 11, and other data integrity requirements


Your data, safe and secure

  • In-house Data Privacy Officer
  • Privacy Policies
  • Standard Data Privacy Agreement (DPA) available for clients
  • DPAs signed with applicable vendors
QbDVision Trust & Privacy
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Your business demands uniform reliability and uptime

Our software is designed for high performance and availability, and built on best-in-class core technologies, such as AWS, so your organization can scale confidently and securely.


Meet our Security & Privacy Leaders

Meet the QbDVision team that works every day to keep our software safe and reliable.


Ryan Shillington

CTO, CISO, Co-Founder


Luke Guerrero



Adrienne O'Reilly

Head of Quality


GxP-ready for your life science needs

  • 3-4 planned major releases/year
  • Master and release-specific validation plans
  • Automated and manual testing
  • IQ/OQ/PQ documentation
  • Transfer PQ package for each major release available
  • 21 CFR Part 11 and EudraLex Volume 4 Annex 11 compliant


You've got questions, we have answers.

QbDVision, Inc. has a comprehensive quality management system that includes documented, controlled procedures for (non-exhaustive list): document control, training, change control (including software configuration management), deviations, CAPAs, validation, client feedback (including complaints), software monitoring, annual product review, management review meetings, internal audits, security, and business continuity and disaster recovery. The company’s quality management system is inclusive of our information security management system, which is compliant to ISO 27001:2022 and SOC 2. Continuous compliance to such is monitored by Vanta, demonstrated here on our trust page:

We regularly update our answers to CCM + CAIQ, and they are available upon request to clients/prospective clients who have signed an NDA. If you’d like a copy of your answers, please email

Try QbDVision today

Test drive our software’s core functionality or book a full platform demo.

Shameek Ray

Head of Quality Manufacturing Informatics, Zifo

Shameek Ray is the Head of Quality Manufacturing Informatics and Zifo and has extensive experience in implementing laboratory informatics and automation for life sciences, forensics, consumer goods, chemicals, food and beverage, and crop science industries. With his background in services, consulting, and product management, he has helped numerous labs embark on their digital transformation journey.

Max Peterson​

Lab Data Automation Practice Manager, Zifo

Max Petersen is the Lab Data Automation Practice Manager at Zifo responsible for developing strategy for their Lab Data Automation Solution (LDAS) offerings. He has over 20 years of experience in informatics and simulation technologies in life sciences, chemicals, and materials applications.

Michael Stapleton

Board Advisor, QbDVision

Michael Stapleton is a life sciences leader with success spanning leadership roles in software, consumables, instruments, services, consulting, and pharmaceuticals. He is a constant innovator, optimist, influencer, and digital thought leader identifying the next strategic challenge in life sciences, executing and operationalizing on high impact strategic plans to drive growth.

Matthew Schulze

Head of Digital Pioneering Medicines & Regulatory Systems, Flagship Pioneering

Matt Schulze is currently leading Digital for Pioneering Medicines which is focused on conceiving and developing a unique portfolio of life-changing treatments for patients by leveraging the innovative scientific platforms and technologies within the ecosystem of Flagship Pioneering companies.

Daniel Matlis

Founder and President, Axendia

Daniel R. Matlis is the Founder and President of Axendia, an analyst firm providing trusted advice to life science executives on business, technology, and regulatory issues. He has three decades of industry experience spanning all life science and is an active contributor to FDA’s Case for Quality Initiative. Dan is also a member of the FDA’s advisory council on modeling, simulation, and in-silico clinical trials and co-chaired the Product Quality Outcomes Analytics initiative with agency officials.

Kir Henrici

CEO, The Henrici Group

Kir is a life science consultant working domestically and internationally for over 12 years in support of quality and compliance for pharma and biotech. Her deep belief in adopting digital technology and data analytics as the foundation for business excellence and life science innovation has made her a key member of PDA and ISPE – she currently serves on the PDA Regulatory Affairs/Quality Advisory Board

Oliver Hesse

VP & Head of Biotech Data Science & Digitalization, Bayer Pharmaceuticals

Oliver Hesse is the current VP & Head of Biotech Data Science & Digitalization for Bayer, based in Berkeley, California. He has a degree in Biotechnology from TU Berlin and started his career in a Biotech start-up in Germany before joining Bayer in 2008 to work on automation, digitalization, and the application of data science in the biopharmaceutical industry.

John Maguire

Director of Manufacturing Sciences, Sanofi mRNA Center of Excellence

With over 18 years of process engineering experience, John is an expert in the application of process engineering and operational technology in support of the production of life science therapeutics. His work includes plant capability analysis, functional specification development, and the start-up of drug substance manufacturing facilities in Ireland and the United States.

Chris Kopinski

Business Development Executive, Life Sciences and Healthcare at AWS

As a Business Development Executive at Amazon Web Services, Chris leads teams focused on tackling customer problems through digital transformation. This experience includes leading business process intelligence and data science programs within the global technology organizations and improving outcomes through data-driven development practices.

Tim Adkins

Digital Life Science Operations, ZÆTHER

Tim Adkins is a Director of Digital Life Sciences Operations at ZÆTHER, serving the life science industry by assisting companies reach their desired business outcomes through digital IT/OT solutions. He has 30 years of industry experience as an IT/OT leader in global operational improvements and support, manufacturing system design, and implementation programs.

Blake Hotz

Manufacturing Sciences Data Manager, Sanofi

At Sanofi’s mRNA Center of Excellence, Blake Hotz focuses on developing data ingestion and cleaning workflows using digital tools. He has over 5 years of experience in biotech and holds degrees in Chemical Engineering (B.S.) and Biomedical Engineering (M.S.) from Tufts University.

Anthony DeBiase

Offering Manager, Rockwell Automation

Anthony has over 14 years of experience in the life science industry focusing on process development, operational technology (OT) implementation, technology transfer, CMC and cGMP manufacturing in biologics, cell therapies, and regenerative medicine.

Andy Zheng

Data Solution Architect, ZÆTHER

Andy Zheng is a Data Solution Architect at ZÆTHER who strives to grow and develop cutting-edge solutions in industrial automation and life science. His years of experience within the software automation field focused on bringing innovative solutions to customers which improve process efficiency.

Sue Plant

Phorum Director, Regulatory CMC, Biophorum

Sue Plant is the Phorum Director of Regulatory CMC at BioPhorum, a leading network of biopharmaceutical organizations that aims to connect, collaborate, and accelerate innovation. With over 20 years of experience in life sciences, regulatory, and technology, she focuses on improving access to medicines through innovation in the regulatory ecosystem.

Yash Sabharwal​

President & CEO, QbDVision

Yash Sabharwal is an accomplished inventor, entrepreneur, and executive specializing in the funding and growth of early-stage technology companies focused on life science applications. He has started 3 companies and successfully exited his last two, bringing a wealth of strategic and tactical experience to the team.

Joschka Buyel

Process & Knowledge Management Scientist, Bayer Pharmaceuticals | Ph.D., Drug Science

Joschka is responsible for the rollout and integration of QbDVision at Bayer Pharmaceuticals. He previously worked on various late-stage projects as a Quality-by-Design Expert for Product & Process Characterization, Process Validation, and Transfers. Joschka has a Ph.D. in Drug Sciences from Bonn University and a M.S. and B.S. in Molecular and Applied Biotechnology from the RWTH University.

Luke Guerrero

COO, QbDVision

A veteran technologist and company leader with a global CV, Luke currently oversees the core business operations across QbDVision and its teams. Before joining QbDVision, he developed, grew, and led key practices for international agency Brand Networks, and spent six years deploying technology and business strategies for PricewaterhouseCoopers’ CIO Advisory consulting unit.

Gloria Gadea Lopez

Head of Global Consultancy, Business Platforms | Ph.D., Biosystems Engineering

Gloria Gadea-Lopez is the Head of Global Consultancy at Business Platforms. Using her prior extensive experience in the biopharmaceutical industry, she supports companies in developing strategies and delivering digital systems for successful operations. She holds degrees in Chemical Engineering, Food Science (M.S.), and Biosystems Engineering (Ph.D.)

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