QbDVision is the first cloud-based Knowledge Management Solution for Pharma 4.0
Risk Assessment and Traceability
Risk Mitigation and Control
Process Flow and Maps
Implementing Pharma 4.0
The Pharma 4.0 paradigm is a new vision for pharmaceutical and medical device manufacturing based on the Industry 4.0 initiatives. Moving beyond the reactive procedures of the past, Pharma 4.0 relies heavily on process-oriented, data-driven and preventative approaches to create robust, flexible manufacturing processes that can significantly improve product quality.
QbDVision is a unique software solution developed by industry veterans focusing specifically on Quality-by-Design (QbD) and Data Integrity-by-Design (DIbD) principles to enable the development of drugs, medical devices, and software under the Pharma 4.0 paradigm.
Together, QbD and DIbD enable the kind of quality risk management and pharmaceutical quality essential for complex manufacturing processes to meet regulatory requirements in the future.
QbDVision is more than Document Management
Focus on tracking specifications with data
Specifications version controlled with e-signature
Specification history automatically generated
Critical variables traced to patient safety and efficacy
Risk filtering and adjustment based on real data
Manufacturing process tracked over time
Gaps in testing more easily identified
Focus on tracking documents
Documents version controlled
Significant time spent drafting documents
Specifications codified in documents
Specification history buried in document history
Risk assessments buried in documentation
Gaps in testing buried in documents
The QbDVision Value Proposition
Create an integrated data repository for all of your development activities with visual tools that easily identify, rank, and trace risk factors.
Use data-based, scientific principles to build process understanding as a precursor to process validation.
Perform iterative risk assessment and adjust requirements as your program evolves and process knowledge increases.
Reduce the likelihood of development batch failures and subsequent re-formulation activities which can trigger new preclinical/clinical work.
Develop a robust, well-controlled, well-documented, and compliant manufacturing process streamlining pre-approval and post-approval inspections by regulatory agencies.
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