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.
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.
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.