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Manual batch record management is an outdated practice that many pharmaceutical manufacturers continue to struggle with. As the FDA requires you to do so, you need to keep records on the batch of each product you produce – it’s a necessary, if tedious, part of your compliance.
But it doesn’t have to be that difficult of a process. Like so many other aspects of your business, by applying the right technologies, you can automate and streamline these processes, enhancing your efficiency and reducing the time spent by your staff.
How? With electronic batch record (EBR) systems.
For so long, batch record management has been a necessary evil. Regulators need to be able to confirm that a number of different standards are being met with any given batch of a product you produce:
Unfortunately, batch management systems date back to before the integration of modern IT systems in the manufacturing workplace. And so, conventional batch management systems were developed manually. Given how complex batch record documents are, these manual processes are error-prone, and can often lead to data integrity issues.
Batch records involve so much paperwork, which is tedious to manage, difficult to index and search, and vulnerable to damage. That’s why, as newer technologies have become available to the manufacturing industry, some firms have begun using EBR systems instead.
EBR systems save firms like yours considerable time and help to avoid the error-prone, vulnerable nature of manual batch record management. They help to make production time cycles much shorter and improve the quality of a given batch, and the accuracy of its record, benefiting both your firm and the regulators tasked with reviewing the batch.
Advantages offered by EBR systems include:
But that’s not all – an EBR system can do even more when integrated properly with your Enterprise Systems…
As beneficial as EBR systems are on their own, they’re much more effective when integrated with your other Enterprise systems. This is all a matter of allowing information from any one area of your firm to flow efficiently into others.
Consider the data involved in your EBR – information about materials, supplies, equipment, operators, and more. Next, consider the information tracked by other parts of your firm, such as test procedure execution, environment monitoring, resource planning, and more. Wouldn’t each be more effective if they had the real-time data from the other to work with?
You need to think about the big picture. Anyone aspect of your firm’s operation influences another. With actionable data flowing securely and in a properly organized manner from one area to another, every aspect becomes more effective at what it’s doing.
Of course, all of this is easier said than done – do you know how to deploy an EBR system and integrate it effectively in your firm?
In order to do this effectively, you need to have a plan as to how to migrate your batch record processes to a digital counterpart and make sure it is integrated properly with your other systems. This means developing a methodology based around your firm’s current and future requirements, designing a laboratory informatics architecture, and roadmap for deployment,
If that sounds complicated, well, it is. But the good news is that you don’t have to do it alone.
Acapella Technologies has extensive experience working with firms like yours in the manufacturing industry. We can assist in finding the right EBR solution for you, and in making sure it is carefully deployed and properly integrated with everything else your firm does.