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Structured Knowledge Management for Pharma/Biotech

Platform and process management to design, develop, and understand your manufacturing process.

The Challenge & The Solution

As manufacturing processes become more complex with the advent of cell and gene therapies and novel modalities for vaccine development, existing frameworks for knowledge management using spreadsheets, reports, and file repositories are no longer tenable.

Knowledge is power and process understanding is gold. The Pharma 4.0 paradigm is a new vision for pharmaceutical manufacturing that relies heavily on quality-by-design principles using science-based, data-driven, analytical frameworks to create robust, flexible manufacturing processes.

 

QbDVision is a unique software solution created by industry veterans to capture the evolution of your drug manufacturing process from laboratory-scale to continued process verification using the principles of Pharma 4.0. Proactive platform and process management require an integrated solution with multiple capabilities and adherence to 21 CFR 11 and data integrity standards. QbDVision® is your solution.

Growing the Knowledge Base

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Requirements Management

Design your process in our structured data repository and link patient, product, and process requirements.

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Project Collaboration

Novel visualization tools such as knowledge graphs simplify analysis of multi-dimensional processes.

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Tech Transfer

Secure, integrated environment maintains data integrity and simplifies tech transfer over the lifecycle.

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Enable Key Workflows

Structure brings automation, and automation can create multiple efficiencies especially as they relate to best practices and worfklows.

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Risk Assessment & Analytics

Progressive risk assessments coupled with process analytics let you track the evolution of process risk.

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Control Strategy ​

Acceptance criteria, criticality assessment, process capability and control strategy tracked together.

Most best practice paradigms for product development start with the end in mind.  Pharma/biotech development is no different with experienced practitioners starting with the patient and product requirements and then thinking about the process. 

This philosophy is enshrined in the quality-by-design methodology which forms the basis of many of the recommendations in the ICH guidelines. QbDVision enables this layered approach to requirements management as the foundation for product development and lifecycle management 

Requirements Management

Is quality-by-design a thought process, a statistical approach, a more efficient development process?  Actually, it is all of the above.  While most people equate Quality-by-Design with Design of Experiments (DOE), QbD is more than just DOE.  It is a comprehensive methodology for product development where the goal is to design quality into the product.  This approach has many dimensions and requires careful management over the many years of a development lifecycle.  QbDVision simplifies the implementation of QbD principles by building them directly into the workstreams enabled by our platform. 

Enabling a QbD Workflow

The efficiency of R&D activities during the lifecycle is a function of the costs of personnel and the resources required for manufacturing, the time to market, and the probability of technical success.  The lack of structured knowledge solutions continues to reduce efficiencies by adversely impacting each of these variables.  What if a software solution enabling knowledge management could reduce the time spent on development by 10%, reduce the costs of manufacturing by 10%, and reduce the likelihood of batch failures by 10%.  What would be the return on your investment?  

Improving R&D Efficiency

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