This post was written by Robert Pochadt, InstantGMP Sales Director.
It is imperative that when considering material management and manufacturing automation software that 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 life span that is finite. 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
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 a finished deliverability, which created a need to manage
manufacturing in the same system. Over time, the simple act of 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 are trusting your product, so you must extend
that confidence in carefully choosing the capabilities of the system
that makes them.