Batch records are a vital part of the Life Sciences industry. Fundamentally, they document the product that you’ve manufactured, which can assist with tracking lots and preparing for audits. Even beyond the Life Sciences industry, there is a push in the manufacturing industry at large to go digital and track information electronically. As a result, many of our clients are looking into Electronic Batch Records (EBR). Of course, there are many benefits to the EBR route:
With all of these benefits, it can be difficult to imagine why anyone would be hesitant to embrace EBR. However, making the switch has some hidden considerations. In order to determine whether this investment is the right choice for your organization, products, and clients, here are a few factors to consider prior to implementing EBR.
Full EBR requires integration of a number of your production platforms including enterprise resource planning (ERP), laboratory information management system (LIMS), manufacturing execution systems (MES), industrial control systems (ICS/DCS/PLC), OT/Cybersecurity, and more. This means multiple stakeholders should be engaged in order to get all of the correct pieces in place, and since every process is different, considerable up-front planning is required. This is the most critical point in the project and is truly the best way to shorten the implementation process. The higher the quality of the up-front planning, the smoother the execution and validation process will be.
Full EBR does not end after the validation process is complete. System upsets such as data loss can still occur, so it is important to plan and execute preventative maintenance programs regularly. All hardware and software within the record system must be maintained. All software updates should be tested beforehand in a development system before implementing on the production system to ensure that interdependent interfaces and communications are not disrupted. Routine checks should be outlined and scheduled to help keep the system up and running.
The more systems you incorporate into your processes, the more types of support are required to maintain interconnectivity and reduce downtimes. This means you must build your organization, or partner with a solution provider, to mitigate and address these disruption issues that are unique to implementing full EBR. The cost of an on-call, or even on-property, support system, whether internal or external, should be planned into the operations budget early. If support staff is not properly engaged, this can lead to gaps in your records, or lost production time, negating many of the intended benefits of EBR.
As with all modern systems, cybersecurity is paramount. With vital pieces of information being stored and passed between systems, routine cybersecurity audits can help identify vulnerabilities and ensure that both hardware and software systems are up to date and secure. Unfortunately, secure systems are still at risk without proper procedures in place to maintain data integrity. Systems must be designed, configured, and maintained such that the data involved cannot be manipulated outside of an audit trail. Data integrity is a key factor in successfully passing internal, client, and governmental audits as well as proving consistency and quality of the products manufactured.
While the benefits of EBR often outweigh the risks, it is important to understand all implementation, maintenance, and support considerations in order to position yourself for success. Do you have the organization to successfully implement EBR? Do you intend to grow your organization to be able to support EBR, or would you prefer to partner with an experienced solution provider? The scope may be intimidating but partnering with a system integrator such as Hargrove can ease the burden on your organization.
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