How to Go from Paper to Electronic Batch Records in GMP Manufacturing

Posted by Rick Soltero

Making the transition from paper batch records to electronic batch records has lots of benefits, yet there is a natural resistance to change that keeps many firms entrenched in their ways. It’s human nature that we are motivated to change only when we are dissatisfied with our current situation.  Even with the obvious advantages that electronic manufacturing provides, there is often too much inertia to overcome.  Part of the issue is that change is disruptive and costly.  It takes money and people’s time to install and start using a new system.  We at InstantGMP have been sensitive to these issues and have used some guiding principles to work out a 4 step process to simply a company’s adoption of an electronic batch records system for GMP manufacturing.

There are several Guiding Principles we use in planning for the transition to electronic manufacturing. The most important realizing that installing a new system is a great opportunity to find ways to improve productivity. Electronic systems can let you do things that are practical with manual systems. You can create more efficient and time saving work flows so this is the time to take advantage of what electronic systems can offer. For example, you can move quality checks that are normally done at the end of your review process and have them done as part of the production process. With a cloud based application like InstantGMP™, you can convert many on-site activities to remote activities. The ability to work remotely will allow you to use part time staff or will let your existing staff work from the road or from home. Overall you can become a more cost effective business.

There are four main steps in moving from manual manufacturing to an electronic batch records system. The first step assessing your manual system and find ways to create new manufacturing workflows that can make your organization more efficient. The next step is implementation. We suggest you start small project and minimize any disruption to normal operations. Prepare a manufacturing process flow that includes non-production activities such as inventory management, room and equipment clearance, in-process testing and yield calculations. After that convert one master production record into an electronic Master Production Record and run virtual demos. When you and your staff are ready start working with one SKU at a time until the electronic batch records are fully employed. When all of the modules of the electronic batch record system are working together you can start to enjoy the benefits of increased productivity, improvements in quality and reduction in costs.

A complete demonstration of these principles and steps can be viewed is in a video entitled “How to Go from Paper to Electronic Batch Records” at our Resource Center – Videos page.

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