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 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:
Table of Contents
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 examines driver assistance, propulsion, vehicle dynamics control systems, and more.
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 Helix 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.
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
Many factors fall into this step of the compliance workflow. The compliance manager is responsible for:
- Staying current on standards.
- Ensuring that all employees understand requirements.
- Aligning business functions with compliance.
- Reviewing processes and operations (and making changes when necessary).
- Recording and correcting violations when they occur.
6. Conduct Periodic Compliance Audits
If compliance is relevant to you, then you probably get audited routinely. But you should have internal audits, as well. They’ll help you avoid mistakes that can be irreparable. As part of these internal audits, keep thorough documentation and records to reference. Though this compliance management documentation should be kept secure, make sure key stakeholders know how to access and interpret it.
Evaluating Requirements Management Solutions?
Get our Requirements Management Software Buyer's Guide to learn 5 questions to ask when comparing traceability and compliance solutions.
Essential Compliance Management Tools
Compliance workflows can look different depending on the specific organization, team, and industry. However, here are a few key compliance management solutions driving most workflows and found in most tool suites:
- Application Lifecycle Management: ALM tools provide end-to-end traceability across a product lifecycle, allowing you to see what requirements have been tested and met. Team members also have visibility into whether test runs have passed or failed, and if issues have been resolved. A comprehensive application lifecycle management solution like Helix ALM incorporates requirements management, test case management, and issue management in a single tool.
- Static Code Analysis: To achieve compliance management, code needs to be compliant, as well. Static code analysis automates the debugging process by analyzing a set of code against a set (or multiple sets) of coding rules. Static code analysis solutions, like Klockwork from Perforce, help teams maintain development velocity while ensuring security and quality.
- Quality Management Systems: A quality management system (QMS) helps teams standardize quality control by identifying goals, inspecting and testing these goals, and reviewing manufacturing and delivery processes.
See How Helix ALM Can Streamline Your Compliance Workflow
Watch our experts walk through what Helix ALM is, how it works, and best practices for creating compliance workflows in the tool. Get access to our guided, 20-minute demo before you decide to test out Helix ALM.
How Helix ALM Supports Compliance Management
Enforcing compliance management — and proving compliance — is easiest when you have traceability for the entire product lifecycle. To achieve this, you need a single repository that captures every change and action taken.
It's also crucial for organizations to activate security functions that prevent making unauthorized changes or skipping steps in a compliance workflow.
Helix ALM, the application lifecycle management solution from Perforce, fulfills these core functions and provides end-to-end traceability and security controls, as well as configurations that can be personalized for your industry and organization.
What Users Say About Implementing Helix ALM in Their Compliance Workflow
Helix ALM has received recognition from G2, a leading software review platform. Here’s a look at some recent accolades, based on reviews from real users:
- Most Implementable
- High Performer
- Highest User Adoption
- Best Support Team
Our latest TechValidate survey also found that 91% of users said that Helix ALM improved alignment around their compliance management requirements and changes.
Join these companies and users in establishing easy, reliable, and automated compliance workflows with Helix ALM. The 30-day free trial is a chance to see how easy it can be to manage requirements, run tests, and track bugs – all in one comprehensive tool.