Regulatory compliance—and the issues surrounding it—come in many forms. The concept refers to the duty of a business to comply with various regulations, laws and guidelines required within them. Industry.
Regulatory compliance is important because it's not just a goodwill gesture to a brand's audience. It is a key responsibility. When violated, it can result in fines, suspension of business activities and worse.
In the field of regulatory compliance, one of the keys to success is staying ahead of potential issues. Instead of waiting for problems to arise, smart leaders look for ways to make them go away.
There are many proactive strategies to identify and address compliance gaps before they escalate into costly issues. Each of them requires the company's time, finances and other resources. However, the regulatory anxieties they help avoid make them well worth the effort.
Here are some proven techniques, examples, and steps for mitigating compliance risks before they become full-blown issues. They can ensure a business maintains smooth operations by proactively navigating the complex regulatory compliance landscape.
1. Establish strong internal controls
The standards that companies use to manage their internal activities can go a long way in avoiding costly mistakes over time. Internal quality controls are also up to scratch for 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 quality TMF or Probation Master File. A quality TMF is important to demonstrate compliance of the clinical trial with regulatory requirements. When a pharmaceutical organization acquires an asset, TMF is part of that acquisition. Just in Time GCP, GCP and TMF compliance consultants, adds that a hard quality proof master file it not only documents the progress of the study but adds value to a brand. In fact, it provides the history of the asset you are buying.
Good sponsor oversight with well-defined quality control processes, such as regular ongoing review and maintenance of an up-to-date TMF, ensures regulatory 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 some similar set of business parameters.
Remember, each industry has its own requirements and regulations. For example, a healthcare provider must follow HIPAA (Health Insurance Portability and Accountability Act) laws, while a technology company must be up to date with the latest GDPR (General Data Protection Regulation) requirements. As a business owner, it's up to you and your team to understand what these priorities are for your brand and industry, and then take steps to meet them on an internal level.
2. Invest in continuous monitoring systems
Protecting a company from cyber threats has become a major concern for 21st century businesses. With thousands of digital attacks occurring every day, IT security has become a major focus of regulatory compliance.
One of the biggest issues with cybersecurity is the never-ending changes happening across the digital business landscape. Cybercriminals are regularly working around existing defenses, and software is constantly adapting to deal with new threats.
One of the best ways to maintain compliance on the digital front is to deploy continuous monitoring systems. This is a form of regulatory technology (regtech) that approaches cybersecurity through persistent security protocols that constantly protect against a breach.
CrowdStrike, an AI-powered cybersecurity company, explains this continuous healthy monitoring cannot keep a system protected from external threats alone. It can improve the visibility of digital activity in a company. This leads to faster diagnoses and accelerated response times.
They explain that this improves mean time-to-resolution, or MTTR, rates, adding, “The sooner you identify errors, the earlier you can begin root cause analysis and the subsequent remediation process. In other words, you you're lowering mean time to resolution (MTTR).”
Continuous monitoring takes many forms. You can apply it to everything from company infrastructure and network monitoring to individual applications. Consider the areas of your company that are prone to cyber threats and ensure that you are implementing continuous monitoring systems to maintain compliance not only now, but in the future.
3. Work with third-party firms, agencies and consultants
The world was already moving towards remote work before the pandemic accelerated its adoption. Since then, many jobs have remained abroad and, in many cases, outsourced to contractors or freelancers.
The sudden explosion of artificial intelligence as an applicable tool in the workplace has pushed this fractionalization and outsourcing of work even further. Leaders in every industry are rethinking their approach to hiring, and for many, the answer is to outsource when in-house teams and AI can't fill a skills gap.
One area where third-party solutions come in handy is compatibility. Compliance concerns often focus on specific areas of a business's activities. For example, they are particularly important for a legal or IT team. Another area is finance and accounting.
Tracking income and expenses and proper tax reporting is a complicated activity. Even with advanced technology tools and AI-powered platforms, it requires human expertise to ensure that a company is not only balancing its books, but will stay relevant over time.
CFO Hub highlights several benefits that come from accounting outsourcing, such as being cost effective, scalable and time efficient. The financial site also points out that using qualified third-party accounting firms provides unique access to industry expertise.
The site adds: “Outsourcing your accounting to a professional team will help you reduce the risk of errors and fraud. Professional accounting firms typically have strict controls and procedures to ensure accurate financial reporting and regulatory compliance.”
If you want to maintain compliance in complex, problem-prone areas like IT or accounting, think twice before assigning them to your in-house team. Bringing in an independent third-party agency, firm, or contractor can imbue your operation with a degree of professional excellence that makes it much easier to stay up-to-date and compliant where it counts.
4. Hire smart and review often
Finally, it is important to consider the long-term maintenance of your compliance. Being proactive 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 aside time to review your compliance systems.
If you put internal controls in place to ensure you follow GMP standards or maintain a meticulous TMF, those internal controls need maintenance. Or, if you install the latest cybersecurity, make sure it's up to date. If you work with a contractor to stay compliant, check in with them regularly.
Frequency is important here. The staffing and recruitment team at Cradlefin Consultants point out that the size of a business, the industry it operates in and the complexity of its operations can influence how often work system revisions are OK.
They recommend one to two years as a general rule, adding, “It is also recommended that any major change within the organization (such as the implementation of new technology) should trigger a review sooner rather than later, so that assess whether these changes have had an impact on efficiency/effectiveness levels.”
With this in mind, review the factors above and assess when reviews should be done in your organization. Consider any interruptions, such as adopting an AI tool or outsourcing a key responsibility.
Along with consistent reviews, invest in your leadership team. A C suite should never get in the way of compliance concerns. Rather, they should help create one culture of top-down compliance. This brings a fresh and authoritative vision to compliance efforts while also maintaining creative momentum as you move forward as a company.
Commitment to compliance AND creativity is a balancing act and one that few leaders can handle well. From CFOs to CEOs, CTOs to Chief Supply Chain Officers, make sure every hire your company makes invests in the long-term compliance standards you're trying to establish for your brand.
Proactively Addressing Compliance as a Company
from financial and legal for technology, manufacturing and supply chains, the need for compliance is everywhere these days. The world is only getting more complex. As technology reaches its pervasive tentacles into every area of business and the global economy continues to bring everyone closer together, the pressure to stay compliant is mounting.
As rules and regulations continue to pile up (and change regularly), it's important that businesses take steps to proactively address compliance concerns before they turn into costly issues. Use the suggestions above to create a plan for ongoing compliance. Remember, the initial effort here and now will save you a lot of time-consuming and resource-consuming headaches in the future.
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