Regulatory compliance—and the issues that come with it—comes in many forms. The concept refers to a company’s obligation to comply with the various regulations, laws and policies required in its industry.
Regulatory compliance is important because it is not just a gesture of goodwill to a brand’s audience. It is a key responsibility. Violations can result in fines, cessation of business, and worse.
When it comes to regulatory compliance, one of the keys to success is staying ahead of potential problems. Instead of waiting for problems to arise, smart leaders look for ways to address them.
There are many proactive strategies to identify and address compliance gaps before they become costly problems. Each of these requires a company’s time, finances and other resources. But the regulatory nightmares they help avoid make the effort well worth it.
Here are several proven techniques, examples, and actionable steps to mitigate compliance risks before they become real problems. They can ensure a company maintains smooth operations by proactively navigating the complex regulatory compliance landscape.
1. Establish robust internal controls
The standards that companies use to manage their internal activities can go a long way toward preventing costly mistakes over time. High-quality internal controls are also the cornerstone of healthy compliance. These internal protocols define ethical responsibilities and maintain accountability in the workplace.
A good example of this in the pharmaceutical industry is the importance of a high-quality TMF or Trial Master File. A high-quality TMF is important to demonstrate compliance of the clinical trial with regulatory requirements. When a pharmaceutical company acquires an asset, the TMF is part of that acquisition. Just in Time GCP, GCP compliance and TMFs consultant, adds that a solid quality trial master file not only documents study progress but also adds value to a brand. In fact, it provides the history of the asset you are purchasing.
Good sponsor monitoring with clearly defined quality control processes, such as: B. regular ongoing review and maintenance of an up-to-date TMF ensures both legal compliance and brand value. It demonstrates a company’s commitment to product integrity and regulatory compliance, whether through a TMF for a clinical trial, a GMP certification for a cosmetic product, or a similar set of business parameters.
Remember that each industry has its own requirements and regulations. For example, a healthcare provider must follow Health Insurance Portability and Accountability Act (HIPAA) laws, while a technology company must stay up to date on the latest General Data Protection Regulation (GDPR) requirements. As a business owner, it’s up to you and your team to figure out these priorities for your brand and industry and then take action to meet them on an internal level.
2. Invest in continuous monitoring systems
Protecting a business from cyber threats has become a major concern for 21st century businesses. With thousands of digital attacks occurring daily, IT security has become a key focus for regulatory compliance.
One of the biggest problems in cybersecurity is the never-ending changes taking place in the digital business landscape. Cybercriminals regularly bypass existing protection measures and software is constantly being adapted to new threats.
One of the best ways to maintain compliance in the digital space is to set up continuous monitoring systems. This is a form of regulatory technology (RegTech) that addresses cybersecurity through ongoing security protocols that constantly protect against security breaches.
CrowdStrike, an AI-powered cybersecurity company, explains that healthy continuous monitoring can not only help protect a system from external threats. It can improve the visibility of digital activities across the organization. This leads to faster diagnoses and accelerated response times.
They explain that this improves mean time to resolution (MTTR), adding: “The sooner you identify errors, the sooner you can begin the root cause analysis and subsequent remediation process. In other words, they lower the mean time to resolution (MTTR).
Continuous monitoring can take several forms. You can apply it to everything from corporate infrastructure to network monitoring to individual applications. Consider the areas of your business that are vulnerable to cyber threats and ensure you implement continuous monitoring systems to maintain compliance not only now but in the future.
3. Work with third-party companies, agencies and consultants
The world was already moving toward remote work before the pandemic accelerated its adoption. Since then, many jobs have remained outside the company and in many cases have been outsourced to contractors or freelancers.
The sudden proliferation of artificial intelligence as an applicable tool in the workplace has pushed this fractionalization and outsourcing of work even further. Leaders across industries are rethinking their approach to employment, and for many the answer is to outsource when in-house teams and AI cannot fill a skills gap.
One area where third-party solutions are useful is compliance. Compliance concerns are often focused on specific areas of a company’s operations. For example, they are particularly relevant for a legal or IT team. Another area is finance and accounting.
Tracking income and expenses and properly reporting taxes is a complicated task. Even with advanced tech tools and AI-powered platforms, human expertise is required to ensure a company not only keeps its books balanced but also remains compliant over the long term.
CFO Hub points out several benefits of outsourcing accounting, such as the fact that it is cost-effective, scalable and time-efficient. The financial site also notes that using qualified external accounting firms provides unique access to industry expertise.
The website adds: “Outsourcing accounting to a professional team will help you reduce the risk of errors and fraud. Professional accounting firms typically have strict controls and procedures in place to ensure accurate financial reporting and compliance.”
If you want to maintain compliance in complex, problematic areas like IT or accounting, think twice before assigning them to your internal team. Bringing in an outside agency, firm or independent contractor can bring a level of professional excellence to your operation that will make it much easier to stay current and compliant where it counts.
4. Hire wisely and evaluate often
Finally, it is important to consider maintaining your compliance over the long term. Proactively dealing with rules and regulations is never a one-time ordeal. It requires constant attention.
This starts with scheduling regular opportunities to conduct reviews. Of course, this starts with checking how compliant your business remains over time. But you want to go further. Also set up times to review your compliance systems.
If you establish internal controls to ensure you comply with GMP standards or maintain a thorough TMF, those internal controls must be maintained. If you’re installing state-of-the-art cybersecurity, make sure it’s up to date. If you’re working with a contractor to stay compliant, communicate with them regularly.
Frequency is important here. The Human Resources and Recruitment team at Cradlefin Consultants advise that the size of a business, the industry it operates in and the complexity of its operations can influence how often work systems reviews are appropriate.
They recommend one to two years as a general rule, adding: “It is also recommended that any major changes within the organization (e.g. implementation of new technologies) should trigger a review sooner rather than later to assess whether These changes had an impact on the level of efficiency/effectiveness.”
With this in mind, review the factors above and evaluate when reviews should occur in your organization. Also take into account any disruptions, e.g. B. introducing an AI tool or outsourcing a key responsibility.
In addition to consistent reviews, invest in your leadership team. Management should never stand in the way of compliance concerns. On the contrary, they should help create a top-down compliance culture. This brings a new, authoritative vision to compliance efforts while ensuring creative momentum is maintained as you move forward as a company.
Commitment to compliance And Creativity is a balancing act that few managers can handle really well. From CFO to CEO, CTO to Chief Supply Chain Officer, ensure that every hire your company makes is invested in the long-term compliance standards you want to establish for your brand.
Approach compliance proactively as a company
From finance and legal to technology, manufacturing and supply chains, the need for compliance is omnipresent today. The world is becoming more and more complex. As technology advances into all areas of business and the global economy brings everyone closer together, the pressure to comply with regulations increases.
As rules and regulations continue to accumulate (and change regularly), it is important for companies to take steps to proactively address compliance concerns before they become costly problems. Use the suggestions above to create a plan for ongoing compliance. Remember, doing upfront work in the here and now will save you many time-consuming and resource-intensive headaches in the future.
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