What is Compliance Management Software?

Compliance Management Software Definition

Compliance management software is designed to help organizations measure and monitor whether a product complies with applicable laws, regulations, and organizational standards as well as the expectations of clients and business partners. The software enables companies to digitally track and maintain documentation such as policies and procedures, employee training records, corrective and preventive actions (CAPAs), and customer complaints. Regardless of the industry or product type, the software solution should make it easy to control and manage compliance evidence. For instance, companies in the high-tech and consumer electronics industries must maintain materials compliance evidence for environmental standards like RoHS, REACH, and conflict minerals. In contrast, medical device manufacturers must handle processes and documentation specific to FDA 21 CFR Part 11 and 21 CFR Part 820.

The Cost

Delivering new products to market is challenging. And It is difficult to see the cost impact of one or more mistakes.

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