The FDA holds virtual biotech companies accountable for the clinical trials they sponsor. If a…
Written by our very own Robert Pochadt –
Those in regulated industries often regard batch records, and their creation, as a sort of necessary evil; those annoying, labor intensive documents mandated by the guidelines that production teams and others love to hate.
Making them electronic can alleviate some of the chronic transparency and completeness problems; but it’s hard to justify this means when the front office revenue-based business demands the most attention. Or perhaps an efficient means of batch record automation is not easily identified or understood.
The good news is there is now a solution to this problem. Batch records can now be made into a true business value solution. There are three pillars to the process:
Configureability—A batch record can now contain more worthwhile data that just who made what when. A savvy production team knows that many factors directly affect production; these should be identified, logged and analyzed. There may be a process, for example, where yield changes with some other variable like temperature. Reporting can even be automated with advancing technologies like IOT for the sake of efficiency. The team should capture and track these values in a flexible format that allows for continuous monitoring, resulting in constant improvement in resource demand, both equipment and labor.
Experienced Guidance—the master records from which batch records are made require a lot of carefully considered data processes. Nowhere else does “garbage in, garbage out” apply more truly. Builders of master records need to work with trusted resources, which know the ins and outs of putting the right instructions and checks in place, for effective modeling and reporting that leads to more efficient production. It also is often advantageous to utilize these same experts to assist in quarterbacking the entire production mapping process.
Integration to other process–vital information—there are other sources of key intelligence that directly impact productivity, such as access to revise-able work instructions and the availability of production equipment. It should be easy to check, and, if necessary, update the status of these sources. It is also very helpful to notify those engaged of imminent changes or approvals that may be required from time to time.
So, what’s the financial incentive to creating batch records this way in the first place? It turns out, a lot. In most of the regulated industries, the value of equipment and operations is much greater that the value of the product that it generates (capital intensive). The mantra….”Keep the process moving! ” applies, in order to make the most from relatively fixed costs. So it becomes important to consider factors like utilization, uptime, task sequencing, labor burden, best performance conditions, etc., that ensure the steady flow of finished product out the back end in an optimized way.
Admittedly we’ve seen this is an education for some growing companies; happily, it can now be a compelling competitive advantage.
Just add up the right numbers the right way and you’ll see!!
Well put Robert! Get in touch to learn more about how to turn your Batch Records into an amazing business tool.