What is a Compliance Management System?

Adhering to regulatory standards during product development isn’t just a legal requirement, but it’s also important for operational success. However, as regulatory requirements shift frequently, most teams find it difficult to stay on track.

According to a study by Globalscape, non-compliance costs businesses an average of $14.82 million annually, nearly 2.71x more than what it would cost to simply stay compliant. On top of that, falling short of regulations can seriously hurt how an organization is perceived.

A Compliance Management System helps teams to follow regulatory requirements in a structured manner during the development of physical or digital products. It helps organizations track obligations, reduce risk, and build a culture of accountability.

Now, let’s understand more about the compliance management system, how it works, and which tools to use to implement it.

What is a Compliance Management System?

A Compliance Management System (CMS) is a framework that helps organizations to implement regulatory and legal requirements, internal policies, and industry standards. With that, teams know what rules apply and follow them during day-to-day work.

A CMS is not just a tool or software. But it includes processes, multiple tools and technologies, defined roles, documentation, internal controls, and different checklists that work together and help organizations to stay compliant.

In simple terms, a CMS helps organizations:

• Identify applicable laws and standards
• Convert them into actionable requirements
• Track whether those requirements are being followed
• Maintain records for audits and reviews

Instead of handling complaints in silos, a CMS provides a structured process and brings everything into a single system. This helps in reducing risks that arise due to non-compliance and staying prepared for the audit without a last-minute headache.

How a Compliance Management System Works

Compliance management is not a one-time setup, but it’s a continuous process. Here is a step-by-step process that any compliance management framework should contain:

1. Identify and Understand Regulations

The first step of the process is to identify all applicable laws, regulatory standards, or internal policies for product development. Teams also need to stay updated with these requirements as they change over time.

This step sets the foundation for everything that follows.

2. Convert Into Internal Requirements

Regulations are often broad and hard to act on directly. So, it is very important to translate them into actionable requirements. Teams should:

• Break regulations into specific tasks.
• Define acceptance criteria.
• Map them with product requirements.

This makes compliance practical instead of theoretical.

Instead of manually translating and mapping regulatory requirements with product requirements, teams should use AI tools like Copilot4DevOps to draft actionable regulatory requirements within Azure DevOps. With such tools, teams can reduce the risk of missed requirements.

3. Implement and Track

Once actionable requirements are defined and mapped, implement them during system or product development. A CMS ensures these are not lost or ignored by assigning ownership of each requirement to team members, tracking progress in real time, and linking requirements to development, testing, or operational tasks.

This step brings compliance into everyday execution.

4. Verify and Validate

A well-established CMS always confirms that requirements are actually being met. It involves:

• Conducting internal audits to ensure regulatory requirements are implemented correctly.
• Validate controls and processes
• Identify gaps early

Verification reduces the risk of failure during formal audits.

5. Report and Improve

A CMS also maintains records and audit reports that show how regulatory requirements are followed during product development. This helps in easily getting approvals from regulatory bodies before product launch.

This continuous loop keeps compliance aligned with changing regulations and business needs.

Also read: Compliance Testing – What Is It, and Why Does It Matter?

Compliance Management System Example

Let’s understand the CMS system through a real-world example.

Assume that one organization is building a medical device that connects with a web platform and mobile application. The system collects patient data, applies analytics, and supports clinical workflows. In such cases, they must comply with GDPR for data privacy, ISO 9001 for quality, and ISO 13489 for safety.

To implement all regulatory requirements, the organization has built a well-structured CMS. It handles all complaints together instead of implementing them in silos.

The process starts by collecting all requirements for all 3 standards in one system. It might be done using AI. These are then translated into clear, actionable requirements:

• Privacy requirements mapped to data collection, storage, and access. So, IT teams can implement.
• Quality standards linked to acceptance criteria and release gates. SO, QA teams can test them.
• Safety controls are tied to design validation and testing.

Each requirement is connected to development work items such as user stories and change requests. This keeps compliance visible during execution.

Testing is also combined. A single validation cycle checks privacy, quality, and safety together.

Finally, a unified audit trail is maintained, linking every activity back to GDPR, ISO 9001, and ISO 13489, making audits more structured and easier to manage.

Common Challenges with Compliance Management

Managing compliance sounds straightforward on paper, but when teams start implementing it, they generally face the roadblocks below:

• Keeping up with regulatory changes: Compliance and regulatory requirements never stay constant. They get changes, new laws introduced, and industry-specific rules shift without any notice. When the team depends on manual tracking, they always fall behind and leave gaps. 
• Scattered documentation and tools: Compliance data is often stored in documents, emails, local Word files, or spreadsheets. This makes it very hard to find, update, or trust the information.
• Lack of traceability: When teams can’t map regulations to actual development requirements, tests, and release tasks, it creates gaps during audits and increases risks.
• Manual, time-consuming processes: When compliance activities are handled manually, they reduce team productivity and increase the risk of errors. One Redditor said that the SOC II audit is coming in 6 weeks, but the actual audit preparation takes multiple months. So, he is already stressed out about how to complete audit reports in less time.
• Scaling compliances alongside growth: What works for a 50-person company breaks down fast when it grows to 500 people. As products and teams expand, compliance complexity increases.

These challenges should be permanent roadblocks for compliance management. To overcome them, start using compliance process software that allows you to manage and track regulatory requirements collaboratively in one place.

How Modern Requirements4DevOps Can Make Compliance Management Easier

As discussed previously, managing compliance becomes simpler when everything is connected. Modern Requirements4DevOps is an end-to-end compliance and requirement management solution that works directly within your Azure DevOps workspace. So, you can manage compliance alongside the project requirements you already manage.

It helps to capture regulatory requirements and link them directly to user stories and test cases within the current ADO workspace. This creates clear traceability without extra efforts and switching between multiple tools.

Furthermore, built-in versioning capabilities and a baseline help in tracking all changes. So, during an audit, teams can see what’s changed and who approved it. Also, it allows for collaborative reviews of compliance requirements with e-signature and is governed by FDA 21 CFR Part 11.

Modern Requirements4DevOps includes a built-in AI assistant, Copilot4DevOps, which makes compliance management faster and easier within ADO. It helps in drafting compliance requirements, analyzing their completeness, and preparing compliance documents with a single click.

With centralized documentation and real-time visibility, teams stay audit-ready at all times. This reduces risk, saves time, and keeps compliance aligned with development.