Newsletter | March 10, 2021

03.10.21 -- Standing At The Intersection Of Advanced Process And Digital Technologies

 
Leveraging The 4 Cs To Deliver Bioprocessing 4.0
 

This article explains the 4 Cs of Biopharma 4.0 — the software, automation, and analytics tools that allow control of unit operations, connection across the process, collection of data, and collaboration such as remote support and cloud services.

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.

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.
Meeting 21 CFR Part 11 Requirements With A Process Monitoring Platform
 

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.

Convergent Bioprocessing: Standing At The Intersection Of Advanced Process And Digital Technologies
 

As Industry 4.0 principles are applied to the biomanufacturing arena and innovative digital technologies emerge, one might refer to the phenomenon as “convergent bioprocessing.”