Why do so many Electronic Batch Record (EBR) initiatives fail to deliver value? The answer is usually simple; the results that would be deemed valuable were never defined up front. Most EBR initiatives start off with the goal of getting rid of the paper batch record and then end with the stakeholder saying, "Great, now how did this help us again?" If the truthful goal is simply to "go electronic" very little value will be realized from an EBR effort, with the exception of pure regulatory compliance. So how do you avoid this pitfall in your EBR initiatives? Define the aspects up front that add value, work toward those, and let those aspects drive the EBR architecture and infrastructure.
Is part of the EBR initiative to streamline production?
If so, then a simple conversion of the paper batch record to an electronic system will not do the trick. In fact, in most cases, cycle times will initially go up after the transition. Streamlining your production often means that your EBR system will end up incorporating many MES type functions for equipment and usage scheduling before cycle times are reduced.
Is "Right the First Time" part of the EBR initiative?
If this is your goal, then the EBR system will need to be integrated with systems that can provide critical data points to the production process (scale weights, room conditions, etc). The EBR system should also be performing calculations that were previously done manually to guarantee accuracy. Your EBR system may end up looking more like a "workflow" application, one that is very prescriptive with work instructions.
Is a streamlined quality review part of the EBR initiative?
Batch reports are often flooded with data that may or may not impact product quality. Exception based reporting is the answer. Quality must trust that the EBR system properly indicates when a deviation from the normal process occurs or when parameters drift out of specification. This can help reduce the review process dramatically.
These are only a few of the aspects that must be considered during the system development process to allow you to extract the full value out of the final EBR system. Let us help you explore these and other key factors of your EBR initiative to help gain the most value from the final implementation.