Newsletter | September 22, 2021

09.22.21 -- Improving Biomanufacturing Efficiency Using Smarter Software

New Pattern Search Feature Helps Engineers Find Anomaly Patterns In Historical Machine Data
Owing to the sheer volume of data streaming from sensor profiles, anomalies observed during process monitoring in historical data are extremely difficult to search due to a lack of time series search tools. Process analysts and plant engineers often desire to extract anomaly patterns, annotate them with process insights, and save these annotated anomaly patterns to compare with future or past anomalies observed.
How Data Analytics Accelerates Transition To Bioprocessing 4.0

Following successful Industry 4.0 implementation in the automotive, communications, aerospace, and other industries, the biopharma industry is now joining the digital revolution.

Implementing Continued Process Verification With Software Automation

In pharmaceutical and biopharmaceutical manufacturing, the amount of process and analytical data per batch is very high. If a structured procedure is not followed, manually collecting the data and trending them statistically is time-consuming and error prone. This e-book describes automation of continued process verification and offers a one-click solution for statistical trending of data, campaign reports, and annual product quality reviews.

Next-Generation Monitoring Of Bioprocessing To Enable Smart Data Management And Analysis

Every step of the bioprocess life cycle generates a massive amount of data at an incredibly fast rate. Given the need to collect and fluidly handle massive amounts of data being generated with tremendous velocity, a new approach to data management is essential. A new platform that includes digital technologies/data management, process analytical technologies, and intensified processing will drive next-generation bioprocessing.

Meeting 21 CFR Part 11 Requirements With Process Automation Software

The FDA 21 CFR Part 11 regulations were established to ensure that new software solutions meet the safeguards and regulations of traditional paper-based recordkeeping. Learn how utilizing a process monitoring platform can aid organizations in meeting 21 CFR Part 11 requirements with unique usernames and passwords, timestamped audit trails, and secure storage of all records.

Bio4C ProcessPad Software

Bio4C™ ProcessPad software is a data collection, visualization, and analytics software platform that facilitates 21 CFR Part 11 compliance and enables bioprocess monitoring, lifecycle management, reporting, investigations, and continued process verification (CPV).

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