QbDVision plans

See what’s included in our Essentials and Professional plans, and find out which one’s right for your drug development teams.

Essentials

Early-Stage/Preclinical

Start your early-stage venture on the right foot with the basics of electronic quality and product lifecycle management.

Starting at

$49 /user/month

Professional

Process Development

A comprehensive software solution to manage all of your process development activities before starting GMP manufacturing.

Starting at

$229/user/month

Professional-XR

Clinical Manufacturing & Process Validation

A validated version of the Standard offering to manage GMP-level process development and validation activities.

Starting at

$259/user/month

Features Essential Professional Professional-XR
Document Management circle-orange light-blue blue
Training Management circle-orange light-blue blue
Supplier Management and Risk circle-orange light-blue blue
Target Product Profile circle-orange light-blue blue
Quality Target Product Profile circle-orange light-blue blue
Process Development light-blue blue
Process Risk Assessment light-blue blue
Raw Material Management light-blue blue
Qualification & Testing light-blue blue
Process Data & Analytics light-blue blue
Control Strategy light-blue blue
Data Visualization Tools light-blue blue
Automated Reports circle-orange light-blue blue
Validation Package (Add-on) circle-orange blue

QbDVision Essentials

Start simplifying quality management

Stuck with an inefficient paper-based QMS or expensive, complex eQMS? Start managing quality and compliance more cost-effectively than ever with QbDVision Essentials—at a fraction of the cost of an eQMS.

Who it's for

Lean teams ready for a streamlined eQMS solution

What's included

Core eQMS functionality that your team can start using in minutes

What it does

Digitally integrate quality and product life cycle management workflows

Training integration

Stop managing training from your inbox. Integrate all your user profiles, training plans, curricula, and assignments into one pre-validated solution that instantly brings your program into cGMP compliance.

Electronic document management (EDM)

Manage your users, training programs, and documents with a single streamlined workflow. Digitally route, review, and sign documents in compliance with 21 CFR 11, all from one searchable platform.

Supplier management

Build a digital GMP supplier database with integrated audit tracking, qualification management, and risk assessment tools. Pull up quality agreements, approved vendor lists, and more in just a few clicks.

QbDVision Professional

Accelerate your product development cycle

Our Professional plan provides full access to QbDVision. Give your team the power to connect their fragmented data, unite their scattered knowledge, and transform it into process intelligence that streamlines drug development.

Who it's for

Growing teams that need a unified framework for their collaboration

What it does

Transforming dispersed data and knowledge into smart, holistic guidance 

What's included

Full QbDVision platform and all functionality (non- or fully validated) 

One centralized source of truth

Consolidate all your teams’ data and knowledge in one structured, searchable hub where they manage their product’s life cycle with the power and efficiency of a modern software tool.

Agile, efficient development processes

Sync, standardize, and monitor critical workflows with a single platform—one that makes it easy to transfer everything you’ve learned to the next development team and their project.

Process intelligence at every step

Turn your teams’ knowledge and date into smart, holistic guidance, timely decision support tools, and powerful visual insights—everything they need to identify the right decision every time.

QbDVision Professional-XR

Our fully validated solution

Want to use your PLM platform as your system of record for managing ICH- and GMP-compliant activities? Our Professional plan is also available as QbDVision Professional-XR, a 21 CFR 11 compliant version of our platform that can have you up and running in a fully validated environment in minutes.

See all our plans in action.

Try QbDVision Essentials today, or book a one-on-one demo of QbDVision Professional or Professional-XR.

Robert Dimitri, M.S., M.B.A.

Director Digital Quality Systems, Thermo Fisher Scientific

Robert Dimitri is a Director of Digital Quality Systems in Thermofisher’s Pharma Services Group. Previously he was a Digital Transformation and Innovation Lead in Takeda’s Business Excellence for the Biologics Operating Unit while leading Digital and Data Sciences groups in Manufacturing Sciences at Takeda’s Massachusetts Biologics Site.

Devendra Deshmukh

Global Head, Digital Science Business Operations, Thermo Fisher Scientific

Devendra Deshmukh currently leads Global Business Operations for Digital Science Solutions at Thermo Fisher Scientific. In this role he oversees operations broadly for the business across its product portfolio and leads the global professional services, technical support, and product education teams.

Grant Henderson

Sr. Dir. Manufacturing Science and Technology, VernalBio

Grant Henderson is the Senior Director of Manufacturing Science and Technology at Vernal Biosciences. He has years of expertise in pharmaceutical manufacturing process development/characterization, advanced design of experiments, and principles of operational excellence.

Ryan Nielsen

Life Sciences Global Sales Director, Rockwell Automation

Ryan Nielsen is the Life Sciences Global Sales Director at Rockwell Automation. He has over 17 years of industry experience and a passion for collaboration in solving complex problems and adding value to the life sciences space.

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

Life Sciences Luminary and Influencer

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 R. 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

Senior MSAT Scientist at Viralgen, Process and Knowledge Management Scientist at Bayer AG

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.)

Speaker Name

Speaker’s Pretty Long Title, Specialty, and Business

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