Learning From The Past to Improve EBR

BatchLine’s co-founder and CEO David Margetts shares key points from the history of EBR and MES that help to guide our product design by learning from the constraints these created in older products.

 

Electronic Batch Recording (EBR) has until recently only been available as a component of a larger Manufacturing Execution Systems (MES). These are systems that were developed in the last 20 years on client server platforms, initially as bespoke solutions for project specific needs and eventually packaged into a product.
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• This custom build history of MES/EBR has resulted in highly powerful yet complex applications that can fit a wide range of requirements and functionalities for the few companies that had the capital and availability of internal teams to deliver and support them.
• Tier 2 sites of the large Multi-National Corporations (MNCs) that had global MES programs were de-prioritised, as central IT and Business teams who were charged with deploying MES realised the business case to deploy the enterprise solution did not stack up and that no local capability existed in what is a highly specialised domain.
• EBR is one of the key core benefits and attractions of a Pharma MES, and it has been traditionally associated with a fully integrated IT environment requiring modern systems and processing equipment whereas Tier 2 sites might be older and not technically ready for such interfacing or data connectivity.
• Due to the legacy client server nature of MES then, the infrastructure costs alone to provide a reliable and complaint solution can run into 100,000’s USD, and such an investment for a Tier 2 site would usually be better spent on hard assets for manufacturing capacity.
• The last 10yrs has finally seen a number of Tier 1 sites implement MES to eliminate paper batch records, albeit through large projects and investments. Meanwhile the tier 2 sites had no realistic viable options but to stay on paper, even as the Industrial world in general has been under pressure to digitise.
• So, what has changed? Today cloud systems and internet connections are prevalent, robust and the norm for accessing everyday applications and are common for even highly business specific processes. By distilling a Pharma manufacturing solution down to EBR, removing the need for any local infrastructure and in a standalone format that provides a paperless data record and review by exception then all sites can rapidly adopt EBR.
• ​In most areas, speed and ease to implement are trumping functional completeness, and so by redesigning EBR for the base premise and to remove the reliance on vendor or central IT services cloud EBR offers a new route to solving a fundamental Pharma industry requirement for efficient batch documentation.