According to FDA’s 21 CFR Part 11, recording and maintaining equipment usage, cleaning, and other GMP activities with the necessary audit trails is essential. Yet, despite its significance, log documentation today is still primarily a time-consuming, paper-based process that puts life sciences manufacturers at serious compliance risk.
Data entry by hand in paper logbooks is labor-intensive and prone to error. First, employees spend hundreds of hours creating, reviewing, and approving logs. Then, during audits and inspections, they waste more time locating this information, which is often stored in various physical locations.
Drawbacks of paper-based log management
The pharma industry has historically needed to be faster to adopt new technology. As a result, many companies continue to follow paper-based log management. However, here are some challenges with this manual and paper-based approach:
Reduced productivity: Manually recording log activities uses many resources. Equipment usage logs take time to physically (and methodically) record the date, time, product, and lot number of each batch. It takes just as long to register the necessary cleaning data. As a result, productivity is severely impacted by manual log management. Read more....
Source Link:- https://www.pharmision.barcodeindia.com/blogs/why-must-pharmaceutical-companies-switch-to-elog-management-solutions/
