Viewpoints about 'FDA 21 CFR Part 820'

Advancements in Regulatory Compliance Capabilities for PLM Show Promise

August 31st, 2011 | by Sean Klein

Keeping in line with ever-changing regulatory initiatives such as RoHS, WEEE or (FDA) 21 CFR Part 820 can be a daunting task, particularly for manufacturers operating in multiple markets or with large numbers of product variants. Not only do regulations have the potential to derail a new product midway through development, but the consequences for non-compliance are often severe, ranging from hefty fines and brand deterioration to litigation and/or license revocation. Read More

Topics: FDA 21 CFR Part 820, PLM, PLM Capabilities, PLM Software Capabilities, PLM Vivo, Product Development, Regulations, Regulatory Compliance, RoHS, WEEE