QbDVision Professional for Product Quality & Lifecycle Management
Structured software to manage the product lifecycle with a focus on product quality.
The Challenge & The Solution
Simply put, the challenge has always been one of dispersed and unstructured data. As a result, institutional knowledge is haphazard, data utilization and integrity are poor, and product lifecycle management is inefficient and reactive.
Created by industry veterans, QbDVision is a structured solution in the cloud redefining how software can capture the evolution of product and process development from candidate selection to process validation and CPV. For the first time, the workstreams of lifecycle management come together in one platform to automate key workflows, eliminate redundancies and advance digital maturity. With the additional layer of quality management capabilities, QbDVision becomes an integrated and comprehensive solution where all stakeholders can collaborate to build institutional knowledge, automate compliance, and advance total product quality.
Cloud-based repository centralizes product and process information within a compliant, structured framework.
Contextualization with Tracking
Structured framework organizes multiple streams of data tracked over time to provide technical and historical context.
Decision Support Tools
Structure and context enable the integration of risk-based visualization and analytics tools to support data-driven decisions.
Process Intelligence & Understanding
A structured application starting with “the end in mind” drives a deeper level of understanding, especially for complex manufacturing processes.
From process development and validation to ICH guidelines to quality-by-design and Pharma 4.0, it feels like there are multiple workstreams all with different expectations and underlying requirements. Upon more careful examination, it turns out that most of these workstreams are asking for the same thing.
QbDVision consolidates multiple workstreams into one master lifecycle workstream following the principles of holistic quality-by-design and quality risk management automating compliance, eliminating redundant tasks, and advancing the objectives of Pharma 4.0 while advancing digital maturity at the same time.
Knowledge grows over time, but with the current approaches to data management for process development, this knowledge is not captured with consistency and coherence. The QbDVision approach creates a knowledge base using the dimensions of product, process, and facility and this knowledge base grows as a development program moves from Early PD to Process Characterization to Yield Optimization (with scale) and finally Commercial Production. QbDVision facilitates tech transfer from one phase to the next and simplifies the transition to MES when it is appropriate.
Build Your Knowledge Base
The power of a structured solution populated with multiple dimensions of information to create a deep knowledge base provides the foundation to simplify and automate key workflows. Want to see risk-based traceability of process parameters to CQAs? Pull up a risk map powered by QbDVision’s knowledge graph technology. Want to track raw material variability? Use our AI engine to automatically extract COA information for each lot of raw material into the material attribute taxonomy defined in QbDVision. For each upload of information, QbDVision will flag specification outliers. These are only a couple of examples of the automation capabilities of QbDVision available today.
Simplify Key Workflows
A Validated Solution
The QbDVision Professional-V solution is the fully validated version of QbDVision Professional. This solution is designed for companies who want to use QbDVision as their system of record for managing process development and validation under the requirements of ICH and GMP. The fully validated solution is 21 CFR 11 compliant and comes with a full qualification document package for transfer to the client during the onboarding process. This package can be accessed via our Client Portal where the various documents demonstrating validation can be downloaded. The validation package includes a Final Validation Summary report which can be used to adopt our validation. QbDVision is a GAMP3 solution and so it does not necessarily require a client-side PQ. However, you are free to complete your own PQ and we are happy to assist as needed.