To face the high demands, from regulatory bodies such as the FDA, and to decrease launch time of new products, companies in this business need total control of their whole process. Since it’s complicated to validate the end product in this industry, it’s even more important with a validated production. Therefore every step of the process must be controlled and traceable.
For instance packaging of pharmaceuticals is a very complex and important part of the process that shouldn’t be underestimated. I.e. a missing logo on the box warning patients about somnolence can pose a serious danger. To get a single version of the truth it’s a must to establish one process/system to create, revise and approve packaging specifications and packaging bills of material. PLM will now allow the company to decrease time to market by getting the artwork right first time and reduce costs through increased reuse of packaging components and brand assets.
Companies within the pharmaceutical industry using the PLM solutions Technia offer have achieved, among other things, elimination of packaging related product recalls and enabled greater throughput with same resources.
The pharmaceutical industry is going through a big shift from measuring and controlling the product and production process quality late in the process to actually designing for quality with a closer integration between R&D and manufacturing. This is where we also see great potential of PLM becoming a strategic tool for pharma companies to improve their quality, shorten the time to market and reduce the costs.