Products which intimately impact the human body and could be harmful are prone to a myriad of quality assurance regulations put forth by law.
This is the case for the medical domain with its pharmaceutical drugs and devices, the food industry and also cosmetics. The concern of regulations is to assure proper formulation and quality, to protect us from unwanted or accidental effects – ranging from causing irritations to seriously affecting health or even threatening life.
In most cases the consumer has no means to assess if a product is good or potentially harmful from looking at it on the outside. We should be aware that this applies to almost everything we eat … or use in bathroom. What can we do? As a member of our highly developed civilization we must boldly trust that someone else has done adequate testing and taken precautions “before we take a bite of it”.
Governmental agencies, such as the Food and Drug Administration, one of the network of regulation authorities in the US, with their scientific experts and research machinery attempt to take care of this challenge by putting forward constructs of rules and regulations, for the manufacturers of such critical products.
To comply those manufacturers ought to have operational processes that set them apart from other manufacturing companies. And regulations apply to different stages of the product life cycle: production, packaging, storing and shipping. They also determine the product’s usage and limits of use.
With the large variety of existing products we have an evenly large variety of regulatory instructions which apply. PLM is there to help manufacturers governing those complex patterns, to comply with regulations in a manageable and transparent way.
Dassault Systèmes Alliance Partner Integware Inc. is specializing to help manufacturing companies using PLM to guide them through the maze of regulations. With all their know-how in life science and consumer package goods industries Integware provides customizable solution modules. These modules are based on ENOVIA PLM as part of Dassault Systèmes industry solutions, which are put to work for individual customers and their usage.
Using a PLM regulatory compliance solution fully endorses the spirit of Total Quality Management . Quality system processes embedded in the PLM system guide users to follow the rules and comply with regulations. Implementation of corrective and preventive action is enforced. Changes – and their effect on compliance – can be managed efficiently and effectively, thus lowering the risk for human error, non-compliance and failure.
In a nutshell, PLM systems give manufacturers the power to govern their products’ entire impact on humans and nature. Industry-specific know-how of companies like Integware is essential to leverage the maximum of value for all.
This concludes today’s view on 3D PLM applications and the many contributions brought by Dassault Systèmes’ Solution Partners.
Although there was not much of 3D today – nevertheless I hope I was able to provide an interesting view on this important topic.