Developing processes and gaining process understanding are essential for successful process development. However, relying on legacy tools and non-digital practices results in fragmented process knowledge, and inefficient and complex development cycles, increasing manufacturing risks.
IDBS Polar Control directly addresses these critical inefficiencies – enhancing parameter management and ensuring accurate process documentation, which paves the way for effective and efficient process development, process characterization and tech transfer.
Our purpose-built solution for parameter and process lifecycle management empowers organizations to fast-track development. Benefits include:
Maintain consistency throughout the entire process—from setting parameters to extracting valuable insights from results. Track and classify process parameters and quality attributes, and determine specifications and limits at a granular parameter level, to monitor their evolution of processes over time and promote informed process control strategies.
Seamlessly integrate key process data into scientific execution with real-time alerts to minimize errors and reduce deviations. Improve documentation and traceability to ensure teams follow consistent processes, reducing the time, resources and need for repetitive experiments.
Monitor process variability in process development and process characterization studies to build the development process needed for yielding high-quality product. Build product and process knowledge together, to establish operating process control requirements and create replicable, reliable processes for transfer between teams.
Keep a comprehensive history of every process parameter to gather knowledge as processes evolve. Link process and product data to establish essential connections between process versions and execution experiments, allowing you to seamlessly view which parameters impacted product quality. This enables continuous process optimization and informed decision-making.
Maintain accurate and organized data to simplify adherence to data integrity and regulatory standards, and to monitor product quality with greater ease. Centralize all data on a single platform, – building trustworthy data and facilitating easier access and management for report creation and regulatory submissions.
IDBS Polar was chosen to help teams capture, structure and interrogate data from a single source of truth, making their collaboration more efficient.
Why the BioPharma industry needs to shift its focus to capturing, managing and leveraging parameter and process data to create process knowledge.
Could digital transformation hold the key to streamlining tech transfers, optimizing process control and reducing costly delays?
Despite advancements in laboratory informatics tools, without accurate documentation of parameters and processes, drug development teams face challenges like data silos, data integrity issues and delayed insights.
IDBS offers best-in-class cloud-based software solutions based on over 30 years of experience and collaboration with 75% of Top 20 BioPharma companies. Industry-leading security and compliance:
21 CFR 11 / GxP compliant.
Our solutions have been designed with extensibility and integration in mind, enabling easy data capture adapted to how scientists work and ensuring data integrity.
Whether you are striving to better understand the performance of your equipment and processes or looking to transform the way you work with model-based insights, our software solutions can help.
