Bioprocessing Data Analytics Software
Biopharmaceutical manufacturers generate and collect massive amounts of data – from incoming material information, quality control results, LIMS, QMS, MES systems, and unit operation sensors. Yet, due to data silos, disparate data formats, data governance issues, and other factors, 70% of bioprocessing data goes unused.
Because better process understanding and improved product quality requires greater use of data, the industry is adopting data visualization and analysis tools together with technologies such as data lakes, cloud computing, augmented or virtual reality (AR and VR), and predictive analytics.
DATA MANAGEMENT, VISUALIZATION, AND ANALYTICS SOFTWARE
To avoid time-consuming, manual efforts, biotech companies need smart data management tools that automatically collect data from disparate sources such as manual records, spreadsheets, external databases, and machine data, and then aggregate it into an analysis-ready format. To this single dataset, biomanufacturers can now apply data analytics, visualizations, and process monitoring technology that improves product quality and optimize processes.
Bio4C ProcessPad™ software is a data visualization, analytics, and process monitoring platform which allows you to easily acquire, aggregate, and analyze bioprocessing data.
Related Resources
- Data Sheet: Bio4C ProcessPad™ Software
Bio4C ProcessPad™ software is a data collection, visualization, and analytics platform that enables bioprocess monitoring, lifecycle management, reporting, investigations, and continued process verification (CPV).
- Article: Continued Process Verification
Continued process verification is critical to maintain the strength, quality, and purity of the final drug product. It is a regulatory expectation as manufacturers are instructed to ensure their process remains in a continual state of control. Learn more in this technical article.
- Article: Bioprocess Monitoring and Control with Multivariate Data Analysis
Manual monitoring of CPPs and CQAs is time-consuming, labor-intensive, and may delay informed decisions on process performance. Multivariate data analysis (MVDA) makes possible a proactive, near real-time approach to monitoring, controlling, and predicting quality and productivity in biomanufacturing processes.
- Article: Software Simplifies Compliance with 21 CFR Part 11 and EudraLex Volume 4 Annex 11
Regulatory agencies wish to ensure electronic records and signatures are equivalent to paper-based records and handwritten signatures. Beyond proving equivalency, software used for electronic records and signatures offers benefits like access control, audit trials, data integrity, and easy search and retrieval of information.
- White Paper: Next-Generation Monitoring of Bioprocessing to Enable Smart Data Management and Analysis
The bioprocess lifecycle for any therapeutic protein includes a complex series of upstream and downstream activities starting with drug development followed by manufacturing, quality release and finally shipping the drug to the market.
- Brochure: Process Development and Drug Manufacturing: Support Services
We provide comprehensive services for drug development and manufacturing, including technical and regulatory expertise and process development support.
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