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by Beth Stackpole, Contributing Editor Posted on Monday, October 31, 2005 2:27:00 PM   | Abstract: | While many experts argue that dedicated systems or even ERP or MES applications are best suited to managing regulatory compliance, others suggest that engineering systems may be better. Here's why... |
As manufacturers struggle under the weight of regulatory compliance, a growing number of IT experts and business strategists are making the case that Product Lifecycle Management (PLM) is a natural fit for helping to automate and manage the process as part of the early design phase. With regulations varied across industries and countries (not to mention across states, in some cases), manufacturers -- particularly those that build and sell product on a global basis -- are faced with a logistical nightmare: to aggregate and track all the required data and produce reports that establish and track compliance. Manufacturers of cell phones or computers that sell product in Europe or China, for example, need to meet recycling targets as part of the European Union's new WEEE (Waste Electrical and Electronic Equipment) regulations. Eventually, they will need to comply with guidelines established by RoHS (Restriction of Hazardous Substances). Car companies are facing similar concerns brought on by the End of Life Vehicle Directive (ELV). Medical device makers are looking at electronic signature requirements resulting from the Federal Drug Administration's CFR Part 11 compliance, and the list goes on. [Click to continue] |