As part of our ongoing commitment to continuous innovation, we are thrilled to announce the next iteration of our QbDVision platform entitled Calypso. The newest validated version boasts mature features to support knowledge and quality risk management specifically for Pharma 4.0. By better managing data generated during process development and scale-up activities, life science companies can accelerate development timelines, reduce development costs and advance the digital maturity of their organizations.
Driven by the latest research, customer feedback, and changes to regulatory compliance, we are proud to provide a modern technology stack built on powerful, adaptive capabilities tailored specifically to the needs of the pharmaceutical industry.
Critica features of the new update include:
- Process flow maps – Automatically generate process maps with the click of a button showing how inputs map to outputs for each unit operation. Quickly export these process maps for inclusion into product development reports, regulatory submissions and other reports. Eliminate time wasted manually generating and updating these maps with flowchart software.
- Quick-Edit Panel – Finally, a real collaboration tool for risk assessment! Forget antiquated spreadsheets and make edits with detailed justifications in real-time as you and your team evaluate risks to product quality. Interactive editing is compliant with full audit trail.
- Bulk actions – Manage multiple Controlled Electronic Records via QbDVision with tools to propose and approve multiple records at the same time in compliance with 21 CFR Part 11 regulations.
- Technology transfer reporting – Enhanced and automate technology transfer related activities including automatic generation of specification reports for the final product, intermediates, components, and raw materials. Other reporting capabilities include individual material and process component reports, unit operations summaries, bill of raw materials, and bill of process components.
- Statistical process control tools – Expanded capabilities for analytics including P-Charts, improved I-MR charts and new process capability metrics to enhance the user experience. Automate evaluation of process capability and generation of control charts without the need for statisticians!
- Flexible risk management plan – We now support even more flexibility to model different risk assessment needs. Configure separate risk management schemas for each type of attribute or parameter defined in the system. Decide which layers of risk you do or do not want to use as part of your risk management plan.
As the leader in knowledge and quality risk management for life sciences, we are eager to hear your thoughts on the newest version of our intelligent data management platform. If you are new to QbDVision, and interested in trying out our solution, it’s available for a free 30-day trial or reach out to learn more about exploring Calypso’s expanded capabilities.