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.


What are the benefits of compliance management software?

A compliance management system makes it much simpler for an organization to ensure adherence to business and regulatory requirements, reduce risks associated with non-compliance, and increase customer confidence in their products and services by streamlining compliance and regulation monitoring processes, automating compliance workflows, and providing data-driven insights into their efforts.

How do you implement compliance management?

Creating a policy and procedure manual is one thing, but if you don’t have a mechanism to enforce those rules and regulations, you run the risk of facing fines, legal action, and other regulatory repercussions. Creating your own compliance program requires hiring a compliance manager, frequently evaluating your policies and procedures, passing audits by your accrediting body, and using a top-down, hands-off, shared, or dispersed form of compliance management.

What should I look for in compliance software?

Compliance management software should be easy to deploy and maintain, requiring minimal IT infrastructure and maintenance on your end. It should also have the necessary security measures in place to ensure data privacy and IP protection.

Other key capabilities include:

  • Maintains tight connection between all of your product design information, quality records, and compliance processes
  • Stores, tracks, and manages all of the documentation associated with quality and product records
  • Facilitates required compliance reporting
  • Helps streamline compliance with various regulations like FDA, ISO, EU MDR, RoHS, REACH, and other industry regulations
What are the four components of a compliance framework?

Four components of a compliance framework: 1. A compliance program that includes policies, processes, training, monitoring, and corrective actions. 2. Commitment from the senior management team. 3. A customer complaint/satisfaction monitoring program. 4. An audit from an independent body.

*Source: https://cybriant.com

Best Practices for Quality & Compliance

Read our guides to learn best practices on how to eliminate issues and risks and launch high-quality, compliant products to market.