Product lifecycle management and the evolution of process development and validation
A suite of software solutions integrating knowledge, risk, quality, and project management to grow as your company grows.
Supplier Management and Risk
Target Product Profile
Quality Target Product Profile
Process Risk Assessment
Raw Material Management
Qualification & Testing
Process Data & Analytics
Data Visualization Tools
The QbDVision Essentials solution is designed for early-stage pharma and biotech companies just getting started on their product development journey. A key element of success over the long-term is a commitment to product lifecycle management which includes a strong culture of quality. The requirements for compliant lifecycle management and quality systems are outlined in many regulatory documents, but early-stage companies often dismiss these requirements with the intention of fulfilling them in the future. The experience required and expense associated with establishing these systems often prevents companies from setting this culture early on. The Essentials package contains all of the tools and features you need seamlessly integrated and is an affordable way to get started on this journey without all the hassle.
Validated, 21 CFR 11 compliant electronic document management with electronic routing and signature
Integrated training management for company policies and procedures with automated tracking and reporting
Assemble document sets into training curricula assigned to individual training plans by users or departments
Supplier management including audits, qualification, and risk
Initial product lifecycle management with Target Product Profiles and Quality Target Product Profiles
The QbDVision Professional-S solution includes all of the capabilities of the Essentials package and provides significantly greater capabilities for knowledge and quality risk management related to process development. Design your manufacturing process including unit operations, assets (i.e. equipment, components, materials), and variables such as material attributes, process parameters, and intermediate quality attributes. Define your control methods and link them to acceptance criteria as part of the overall control strategy for critical variables (e.g. CQAs, CPPs, etc.). Evaluate process data to establish process capability as part of the overall risk profile. Link the different aspects of your process to create a multi-dimensional data set that is tracked over time and visualized with novel graphical tools to develop process intelligence and understanding.
Full knowledge and quality risk management system for companies tracking process development activities
Product and process risk assessments based on FMEA approach preferred by regulatory agencies
Process design including unit operations, manufacturing, and facilities with qualification status and tracking
Risk-based requirements management and visualization for process intelligence and understanding
Definition of control methods and control strategies to manage residual risk to product quality
Integrated analytics for process capability and novel tools to visualize cause and effect
The QbDVision Professional-V solution is the fully validated version of QbDVision Professional-S. 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 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.