Electronic Logbook Management with Real-time Analytics

Most companies still rely on manual processes and physical paper logbooks to satisfy the FDA’s requirements for logbook management, but this approach has many disadvantages:

• Reduced productivity: Manual documentation of log activities is a significant drain on resources. It's time-consuming to physically (and methodically) record the date, time, product and lot number of each batch for equipment usage logs. Logging the required cleaning data is equally tedious. Manual log management takes a severe toll on productivity. 
• High probability of human error: Mistakes are inevitable because of the sheer volume of information you must log. Whether you recorded the information incorrectly or it's simply illegible, the outcome is the same—your compliance risks increase dramatically.
• Increased threat of FDA 483s and Warning Letters: Inaccurate paper logbooks can lead to deviations, Form 483 observations, warning letters, and even regulatory fines and sanctions.
• Data loss and rework: It's easy to lose paper logbooks due to human error or natural disasters like floods and fires. Employees often spend hours repeating work they've already conducted. These delays are inefficient, increase production costs and impede time to market.
• Lack of visibility: Typically, physical logbooks are not centrally located. You must search through stacks of paper records in offsite document storage facilities to review historical log data. This wastes time and can be detrimental during an audit or inspection when every second counts. Aside from the inconvenience, offsite storage is expensive.