Information silos are problematic in most large organizations, but especially so in pharma and biotech where digital maturity lags other industries due to the heavy regulatory burden of validation. These silos reduce transparency and visibility, hindering process understanding, frustrating technology transfer, and challenging product development cycles.
QbDVision addresses these challenges by integrating the key functions of product, process, and quality management within one cloud-based, validated software environment.
PRODUCT.
PROCESS.
QUALITY.
INTEGRATED.
QbDVision is the first structured, cloud-based software platform integrating product, process, and quality management for Pharma 4.0
A central repository for all of your process development and validation information to enable robust process understanding and control
QbDVision is a unique software solution developed by industry veterans specifically to track the historical evolution of manufacturing process development and validation under the principles of quality-by-design and data-integrity-by-design. It is a flexible tool that can be used for any manufacturing process to enable robust process understanding and control under the Pharma 4.0 paradigm.
Cell & Gene Therapies
Monoclonal Antibodies
Upstream
Immuno- Oncology
Downstream
Small Molecules
Vaccines
Formulation
Drug Product
Drug Substance
Bring it all together under one, integrated, secure, and validated environment
The industry is used to having its process development data scattered across spreadsheets, reports, slide decks, emails, etc. With the increasing complexity of manufacturing processes, this approach is no longer tenable. Demonstration of process understanding and robust process control is now critical for regulatory approval and this requires one platform to define and link all of your information.
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Unit Operations
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Steps
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Acceptance Criteria
Process
Assets
Variables
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Raw Materials
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Equipment
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Parts
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Environment
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People
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Quality Attributes
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Performance Attributes
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Process Parameters
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Material Attributes
Product
Facilities
Manufacturing
A structured platform facilitates visibility, collaboration, and automation which in turn reduces technical and regulatory risk
Structured data platforms simplify data entry using forms that collect information aligned with the defined structure. As information is collected, a multi-dimensional data set is created one layer at a time. Once information is aggregated and contextualized within a single environment, it can simplify workflows for manufacturing decision support. Novel visualization tools such as the QbDVision C-E-RiskTM map built on its K-graph technology provide process intelligence well beyond the standard fishbone diagrams employed today.
The QbDVision Value Stream enables process intelligence and understanding simplifying technology transfer and change management.
The transfer of process development from one scale to the next or from one organization to another is a ubiquitous challenge in the pharma and biotech industries. Beyond tech transfer, there is the challenge of managing changes to validated processes. The structured approach enabled by QbDVision aggregates and tracks the historical evolution of process development providing rich understanding and intelligence to inform the design and development for the next scale of production. It also simplifies compliance with the new requirements of ICH Q12 around changes to manufacturing processes post-approval.
Unstructured Information
Structured Repository
Decision Support Tools
Process Intelligence & Understanding
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Information Silos
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Hard to find and track
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Lack of visibility
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Lack of context
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Aggregate
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Organize
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Contextualize
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Connect
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Track
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Risk Assessment
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Visual Process Mapping
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Raw Material Management
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Manufacturing Readiness
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Cause & effect relationships
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Impact assessment of process changes
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Technology transfer and control strategy
Our customers understand that the process is the product and digital maturity is essential to their future success.
What Our Users Say About QbDVision
I input the generated data live in work sessions with my clients, and then parse and focus the data with the powerful software tools myself to help them gain insights that otherwise would not be available. So far, clients have liked these reports and ask how they have been generated. From a time perspective, data input has to be done no matter what in this industry, and the software provides Excel templates to get this done quickly. I use it for small molecules, peptides, and biologics, as well as combination products; e.g. nebulizers, auto-injectors, etc. In terms of regulatory impact, the FDA recently approved a product developed by one of my clients, where the dossier contained elements of the software reports. FDA accepted these submission elements, without comment."
- Peter Knauer, Sage Biopartners
"We’re very happy with your responsiveness to our input and progression of the product – it’s becoming more user-friendly and powerful, strong attributes needed for implementation."
- Vice President, Process Development
Gene therapy company
