Prioritize GMP Compliance When Choosing Material Management Software
It is imperative that when considering material management and manufacturing automation software, one evaluates the quality of the regulation checks and balances integral to the system and aims to prioritize GMP compliance.
One of the “10 things that ERP and manufacturing systems vendors won’t tell you” is that the new, shiny system you are considering will have a finite life span. Not only do your business processes change since your initial investment, but the world will change too; this is especially true in FDA-regulated industries, where new regulatory mandates could surface; often, these new operations must then be done manually or in a workaround mode, to get done at all.
This is nothing new. Most computer applications evolve as they are used. Many of what we now call ERP systems began life as strictly accounting applications. There was some sense to this; all businesses need to keep the books, no matter what they do, so why not go for the biggest market possible? Then, many firms needed to automate the procurement of merchandise, which created a need to manage purchasing, customer orders, and inventory. Sometimes, the inventory had to be built to finish deliverability, which created a need to manage
manufacturing in the same system. Over time, balancing supply and demand with software turned into a breathtaking complexity of managing pertinent resources and timelines. Organizations like APICS sprung up as forums to share user strategies and implementation war stories. Now add the regulatory dimension of your industry to the mountain of code that is already there; if you‘re lucky (and the vendor wants the market), they will put at least some compliance-ware in a future release; if not, you might be in the third party provider world…or on your own. You might put some feelers out for the next system at this point.
If your company system is at the end of its useful life cycle and if you are FDA-mandated, put the GMP requisites at the top of your new system requirement list. I personally have seen too many costly problems lingering in the field because these matters were initially overlooked or undervalued. Ensuring compliance is your responsibility; don’t get too comfortable too quickly in the world of cool features and even industry references if GMP is not
demonstrably baked into the software workflow. You must do this. Remember, your customers trust your product, so you must extend that confidence by carefully choosing the capabilities of the material management software that makes them.