生物处理数据分析软件

Data Visualization and Analytics Software for Biotech

生物制药生产商生成并收集大量数据，这些数据来自进料信息、质量控制结果、LIMS、QMS、MES 系统和单元操作传感器。然而，由于数据孤岛、不同的数据格式、数据治理问题和其他因素，70% 的生物处理数据被闲置。

由于更好地了解流程和提高产品质量需要更多地使用数据，因此该行业正在采用数据可视化和分析工具以及数据湖、云计算、增强或虚拟现实（AR 和 VR）和预测分析等技术。

数据管理、可视化和分析软件

为了避免耗时的人工操作，生物技术公司需要智能数据管理工具，这些工具可自动收集来自不同来源的数据，如人工记录、电子表格、外部数据库和机器数据，然后将其汇总为可用于分析的格式。对于这一单一数据集，生物制造商现在可以应用数据分析、可视化和流程监控技术来提高产品质量和优化流程。

Bio4C ProcessPad™ 软件

Bio4C ProcessPad^™ 软件是一个数据可视化、分析和过程监控平台，可让您轻松获取、汇总和分析生物处理数据。

相关资源

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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