Compliance Management 101: Best Practices for Establishing Your Compliance Workflow

Compliance management is crucial across a wide variety of industries, from automotive software to medical devices. These regulations protect customers and enhance safety, but they can also introduce challenges and stress for development teams. 

When working in regulated industries that create sophisticated, complex products, compliance management becomes more intricate. If stakeholders miss a design or coding flaw early in the product development lifecycle, but it isn’t discovered until later in the workflow, the time and cost needed to go back and fix it can be enormous. 

In fact, a report from Forbes Technology Council pointed to recent compliance fines and penalties, noting that these totaled $95 million for one Fortune 500 company. This illustrates how compliance failures can be financially disastrous – as well as shake consumer trust in a company. 

However, ensuring compliance management can be a more streamlined and convenient process than many teams expect. That’s because application lifecycle management tools like Perforce ALM (formerly Helix ALM) help you create and automate compliance workflows, plus maintain end-to-end traceability. Learn more about these solutions, why compliance management is essential, and key steps to take to get started, or jump to the section that interests you most: 

What Is Compliance Management? 

Compliance management is the continuous process of monitoring both internal and external policies and procedures to meet industry standards.  

To achieve compliance management, organizations often establish compliance workflows to guarantee each team member is on the same page and working toward clear goals. These processes should account for the entire product management lifecycle.  

Compliance management and compliance workflows vary depending on the industry. Here are a few common standards and regulations.  

Automotive Compliance Management 

Compliance management for the automotive industry incorporates all functional safety aspects of the development process, from automotive software design to configuration and validation.  

The most critical standard for automotive companies is ISO 26262. This is the international functional safety standard for the development of electrical and electronic systems for road vehicles. 

Perforce ALM is now ISO 26262 certified! 

With ISO 26262 certification, the Perforce ALM solution is proven to meet strict safety and reliability standards, reducing risk in automotive development as well as autonomous systems, robotics, aerospace, and other mission-critical systems.

Read More about ALM's ISO 26262 Certification

Medical Device Compliance Management 

In the medical device industry, the U.S. Food and Drug Administration (FDA) requires regular audits to ensure compliance, often at least annually. Some of the most prominent standards include ISO 14971 (risk management), ISO 10993 (biocompatibility), and IEC 62304 (medical device software). In Europe, the CE mark certifies that a product has met EU environmental, health, and security standards.  

Financial Compliance Management 

Compliance management in the financial industry involves making sure consumer data remains confidential, protecting credit card information, and ensuring the effectiveness of information security controls. Top compliance standards include SOC 1, SOC 2, ISO 27001, and the Payment Card Industry Data Security Standard.  

Why Is Compliance Management Important? 

Compliance management is important because it ensures that companies are meeting a reliable, baseline standard that all products across an industry must adhere to, protecting consumer safety.  

An article published in Elsevier, a leading healthcare technology journal, attributed up to an 80% reduction in accident risk to increasing compliance regulations.  

Today's consumers are also more proactive about their own safety and more aware of these standards. The ACA Group, a leading financial compliance organization reported that 44% of clients now request to see a financial institution’s compliance audits and documentation before buying a product or service or entering a contract.  

Compliance Management Challenges 

Compliance management itself is challenging, but anticipating potential obstacles as you plan your compliance workflow can reduce confusion, stress, and difficulty. Understand these underlying hurdles to work more effectively: 

Distributed Teams Across Multiple Platforms 

In an increasingly remote world, it’s difficult to assess overall risk and implement procedures across disparate systems. A report from the software company Okta found that today’s companies incorporate 175 systems and tools into their workflows on average, drawing attention to the challenge of working across multiple platforms. A tight compliance management plan often involves investing in modern, centralized technology that improves visibility and team alignment. 

Volatile Security and Compliance Landscapes 

Exponential advances in technology and rapidly shifting security threats mean compliance can change quickly. Swift updates may be needed without much warning, and — as mentioned above — someone must be responsible for keeping the plan up to date. Changes to requirements must also be communicated effectively to all stakeholders to keep everyone aware and on the same page. 

📕 Related Resource: Security vs. Compliance: What’s The Difference? 

Accounting for Third Parties in Your Compliance Workflow 

It’s likely your organization relies on consultants, manufacturers, suppliers or vendors, as well as other external parties as part of your product lifecycle. In these cases, you can’t be there to manage their processes for compliance purposes. What you can do is to notify all third-party entities you’re working with of your compliance management standards, require them to fully align with them, and provide evidence (audit reports) for doing so. 

Establishing Clarity in Language 

Effective compliance management relies on using very clear language, being as specific as possible about what it looks like to be compliant and considering the complexity of your instructions. Due to the complicated nature of compliance management, this can be difficult – but it’s essential to make sure every team member within your organization knows what is being asked of them and is on the same page about how to achieve it. Consider regularly reviewing your documented policies and procedures to see if they’re still relevant, current, and direct.  

Choosing Between a Rigid and Flexible Approach 

While some compliance issues are clearly defined, there can be cases where gray areas occur. Sometimes this happens when there are two conflicting sets of standards, and you need to make the call on which is most important. 

Compliance Management Tools Can Be Costly  

Implementing compliance management tools can be expensive for companies. Though these costs are largely unavoidable – and failing compliance costs even more – they introduce the need to shop around and closely compare options and competitors. It’s worth noting that tools like Perforce ALM are more affordable than expensive legacy solutions like Micro Focus, allowing teams to work more efficiently at a fraction of the cost.  

Tips to Minimize the Hidden Costs of Compliance Audits 

Completing an audit can come with unexpected costs – including not only certification fees, but also the potential cost of failing the audit. Our Hidden Costs of a Compliance Audit webinar details how to avoid these hefty fines and ensure a smooth audit process.  

WATCH WEBINAR 

Steps for Creating Your Compliance Workflow 

Your compliance workflow plan should include the steps and tasks that must be followed to ensure compliance. It should go hand-in-hand with your internal compliance audit process, as they have shared goals.  

As you write your plan, follow these tips to help ensure that you cover everything. 

📕 Related Resource: Compliance Audit Best Practices 

1. Understand the Landscape and Conduct a Thorough Risk Assessment 

In the majority of industries, regulatory standards are well-defined and serve as the foundation of the compliance plan.  

Based on research and industry knowledge, identify where potential failures could occur, what they look like, how to prevent them, and how to correct them. 

This notion doesn’t necessarily need to be tied to a regulation, but to a good understanding of the business, customers, and main pain you are trying to resolve with your product — along with any other business factors that should be considered. 

2. Define Your Compliance Management Goals 

Based on this comprehensive research, work with a team of cross-functional stakeholders to clearly define your compliance management goals.  

Understand and articulate the standards you are trying to reach, your timeline for achieving them, and what role each team member will play.  

3. Establish Corporate Policies and Procedures 

Compliance should be a top-down initiative, and everything your risk assessment covered should sculpt your policies and procedures. Craft the policies that will help you achieve your defined compliance management goals  

4. Communicate the Plan and Provide Training 

Remember that the greater the risk, the more attention to detail is important. Help employees understand the gravity of accuracy. Also make training as easy as possible to understand. That can mean anything from bilingual training, to diving into specific examples. Employees must understand a compliance workflow to follow it.  

5. Account for Routine Maintenance