FDA

To meet the strenuous requirements of Current Good Manufacturing Practice, if there were ever an industry segment which needs Industry 4.0 implementation, it would be the pharma industry. Let’s examine how a modern MES is able to help manufacturers in the pharma segment better manage their production and their supply chain to unleash Industry 4.0 benefits.

The urgency of response to Covid-19 and the market whiplash are causing MedTech companies to rethink their product mixes to either innovate or partner with other technology companies to answer the pandemic needs. MES has reinforced its place as a critical component in GMP for these companies.

Instead of a painful, time-consuming and costly process, what if being audited by the FDA, or any other regulatory body, was just part of the day to day routine? For the MedTech industry this makes perfect sense – it would not only reduce the financial overheads associated with being audited, it would also substantially reduce time and business risk.

To bake a good cake, you must get the processes right. These include mixing to the right consistency and baking at the correct temperature for the appropriate length of time – but fundamental to your success is the recipe. To create your masterpiece, you must add the right ingredients in the proper quantities. The same is true for the MedTech manufacturers producing combination medical devices.