QbDVision is the first cloud-based Knowledge Management Solution for Pharma 4.0
Requirements Management
Supplier Management
Material Management
Risk Assessment and Traceability
Risk Mitigation and Control
Process Capability
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
QbDVision
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Focus on tracking specifications with data
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Specifications version controlled with e-signature
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Specification history automatically generated
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Critical variables traced to patient safety and efficacy
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Risk filtering and adjustment based on real data
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Manufacturing process tracked over time
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Gaps in testing more easily identified
Document Management
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Focus on tracking documents
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Documents version controlled
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Significant time spent drafting documents
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Specifications codified in documents
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Specification history buried in document history
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Risk assessments buried in documentation
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Gaps in testing buried in documents
The QbDVision Value Proposition
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Create an integrated data repository for all of your development activities with visual tools that easily identify, rank, and trace risk factors.
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Use data-based, scientific principles to build process understanding as a precursor to process validation.
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Perform iterative risk assessment and adjust requirements as your program evolves and process knowledge increases.
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Reduce the likelihood of development batch failures and subsequent re-formulation activities which can trigger new preclinical/clinical work.
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Develop a robust, well-controlled, well-documented, and compliant manufacturing process streamlining pre-approval and post-approval inspections by regulatory agencies.
