Regulatory compliance is the act of adhering to laws and regulations that govern the operations of a business. It is of crucial importance to many industries, including the medical and healthcare sector. In general, non-compliance can result in legal penalties and loss of the company’s reputation. In the case of the medical industry, failure to comply may also have serious consequences to public health and patient safety. This is why it is important for businesses to have a comprehensive understanding of the regulations and guidelines they must follow, and what are the best practices to stay updated on the changes in regulations.
As an experienced CRO, ECLEVAR has years of practice in helping businesses with regulatory compliance in the health industry. This article lays out some of the strategies your company can implement to master regulatory compliance.
Strategies That You Will Learn in This Article:
- Strategy 1: Stay Informed About Regulatory Requirements
- Strategy 2: Build a Compliance Management System
- Strategy 3: Conducting Regular Compliance Audits
- Strategy 4: Training and Educating Employees
- Strategy 5: Enhancing Compliance with Technology
- Strategy 6: Consulting Experts
Strategy 1: Stay Informed About Regulatory Requirements
The regulatory compliance guidelines are always changing, no matter the industry in question. Therefore, knowing the laws and regulations your company must adhere to can be a challenge, but it is the first step to implementing the right regulatory compliance procedures. Without having a clear picture of the regulatory landscape your company is part of, it is impossible to guide your team to work proactively towards regulatory compliance.
That is why the first strategy we share here is to stay informed about the specific regulatory requirements for your industry. Here are some tips on how to stay updated on the laws that affect your business:
- Be sure to invest some of your team’s time and resources into researching and understanding the compliance laws that are relevant to your industry.
- Join industry associations and attend conferences and events, even if the main topic is not regulatory compliance. Engaging with other professionals is a good way to stay informed about the regulations that guide your field of expertise.
- Ask for guidance from legal and compliance experts to understand the regulations and their importance before planning on how to adhere to them.
Strategy 2: Build a Compliance Management System
A compliance management system is a record of the policies and procedures your company must follow in order to ensure ongoing regulatory compliance. It is a good way to systematize and streamline the adherence to regulations and can simplify the process for everyone involved. Be aware that this system must be regularly reviewed and updated to accommodate for the constant changes in the regulatory environment.
Follow this 5-step process to build your own compliance management system:
- Identify regulatory requirements: This is also part of the first strategy we have introduced. Make sure your team is aware of all relevant regulations before planning the regulatory compliance strategy. Regulatory bodies and trade organizations documents are the primary source of this information.
- Define compliance policies and procedures: Now it is time to design the policies and procedures that ensure compliance. List all steps that must be taken and assign responsibilities to the right people.
- Train employees: Providing training and informing employes on specific regulatory requirements is an essential part of your regulatory compliance management system. We will dive deeper into this aspect of regulatory compliance in another section of this article, as this is a crucial part of the process.
- Set Up a Compliance Monitoring Schedule: Know when audits and reporting are happening and make sure this information is shared across teams. Regular auditing is one of the strategies to master regulatory compliance that you will learn in this article.
- Update policies and procedures: After the compliance management system is ready and already being implemented, there should be someone responsible for monitoring the changes in regulatory requirements and keeping the system updated.
Why Compliance Monitoring and Reporting is Important
Compliance monitoring refers to the identification and investigation of potential compliance issues, as well as providing recommendations for avoiding or correcting them. Compliance reporting is the act of regular reporting compliance activities and status to company managers and all other stakeholders.
By making compliance monitoring and reporting a habit, companies can ensure sustainable compliance and prevent potential regulatory risks. Monitoring and reporting should be a proactive part of the regulatory compliance strategy, meaning that employees are actively involved in making the business stay ahead of potential compliance issues and quickly address them. Using technology solutions and collaborating with legal and compliance experts are also useful tips to ensure regular, effective and transparent compliance monitoring and reporting.
Strategy 3: Conducting Regular Compliance Audits
A compliance audit is an event when policies and procedures are reviewed, the effectiveness of training programs is assessed, and the record-keeping methods are evaluated. The aim of conducting regular compliance audits is to identify possible gaps or deficiencies in your regulatory compliance system and take corrective action. The audits also have the potential to identify compliance risks and provide instructions to the team to avoid them.
You should aim to conduct these audits on a regular basis, but extraordinary audits should also be prepared and executed whenever there are significant changes in regulations. This is essential to ensure ongoing regulatory compliance. Keep reading to learn how to plan and implement a compliance audit.
How to Plan a Compliance Audit
This is when you develop a detailed plan for the audit scope, objectives, and procedures. Follow this helpful checklist to build your compliance audit plan. Your plan should include:
- Names and roles of the audit team members
- Timelines and deadlines
- Helpful resources
- Information on the current size and complexity of the company
- List of the regulatory requirements applicable to the industry
- Any recent regulatory changes
- A review of previous audit reports and corrective action plans
How to Execute a Compliance Audit
There should be a team dedicated exclusively to conducting the audit. They will conduct interviews with employees, review records and documents, and observe operations. Then, based on the resources available in the audit plan and the reviewing of the industry regulatory requirements, the audit team will assess the current regulatory compliance.
Finally, the audit team is also responsible for documenting any non-compliance issues that they find and providing recommendations for corrective action. As a last stage in the audit process, these findings should be communicated to the senior management and the board of directors. People in charge should know the risks and be able to plan appropriate action.
What are the Benefits of Conducting Regular Compliance Audits?
- Preventing potential compliance risks by acting before they become significant issues
- Ensuring ongoing regulatory compliance
- Earning the trust of customers and investors by demonstrating commitment to regulatory compliance
- Reducing costs by streamlining compliance processes and improving its efficiency
- Creating a culture of compliance among employees
Strategy 4: Training and Educating Employees
Building a strong regulatory compliance culture among your employees is an essential part of your compliance strategy. Here are some effective actions for educating staff members of your company and training them to ensure regular compliance across all departments.
- Offer frequent compliance training programs, seminars or workshops, giving employees the opportunity to learn about specific regulatory requirements. Adapt this training to different departments and job functions, allowing all employees to receive relevant and tailored compliance training.
- Use real-life examples and case studies to help demonstrate the importance of compliance concepts and requirements and the consequences of non-compliance. It is easy for people to assimilate the relevance of a regular action if they can see the actual results of the tasks they are assigned.
- Incorporate compliance training into onboarding processes for new employees. Setting a strong foundation for compliance culture from the beginning is better than trying to re-educate a whole team. Give new employees the chance to ask questions and seek clarification as needed.
Strategy 5: Enhancing Compliance With Technology
Technology can be a helpful tool to streamline a wide range of processes, and this is also true to regulatory compliance. There are many software solutions and digital tools that can help you to navigate the complex compliance regulations and better organize your team to ensure compliance.
A popular example of regulatory compliance tools is compliance management software, which is designed to automate compliance workflows. This helps companies to develop and implement policies and procedures for ongoing compliance more effectively. Using technology and automating processes reduces the risk of human errors and frees up time for other critical tasks.
Another example is compliance tracking software. This tool is designed specifically to organize the tasks, deadlines and certifications related to the company’s compliance efforts. These softwares are especially recommended for larger companies, which can face more challenges keeping track of all the regulatory compliance tasks that need to be accomplished to stay updated with regulatory requirements.
Data analytics tools are also recommended by regulatory compliance experts. They are used to identify potential compliance risks, which can then be addressed before they become issues. The regular compliance audits should provide data that can be analyzed and generate valuable insights to continuously improve your regulatory compliance processes.
ECLEVAR recommends using technology to achieve regulatory compliance. Tools such as compliance software solutions and data analytics tools can help streamline the regulatory compliance strategy and safeguard the company’s reputation.
Strategy 6: Consulting Experts
Legal and compliance experts are professionals who have in-depth knowledge of compliance regulations and are well-versed in the legal requirements of different businesses. They are the people you should consult with to understand all the implications, for your business, of non-compliance. Your company may be subject to fines, reputational damage and legal action, and seeking the guidance of regulatory compliance experts to avoid that is a highly recommended strategy.
After informing about the implications of non-compliance, these experts can also assist in creating and reviewing compliance policies and procedures. Compliance experts know the best practices for regulatory compliance and can help to ensure that you are implementing policies that are up to date. Finally, they can also work on designing the training programs which were mentioned in the previous section of this article.
Highly regulated industries such as the healthcare industry benefit even more from collaboration with regulatory compliance experts. In this field, non-compliance can have serious implications on the life of patients. By working closely with experienced regulatory affairs professionals, your company can minimize risks and implement proactive strategies to prevent the consequences of non-compliance.
Bonus Tip: Taking a Risk-Based Approach
The risk-based approach is a mindset that helps your team to quickly identify the areas of your business that present the highest risk of non-compliance, and then focus the work on these areas. Consider conducting risk assessments to identify potential hazards and classify them according to the probability of occurrence. Then, allocate resources to and focus the work on the most probable ones.
How ECLEVAR Can Help Your Regulatory Compliance Strategies
Ensuring regulatory compliance is essential for the success of medical businesses and the safety of patients. By employing strategies such as understanding the regulatory requirements, implementing a compliance management system and consulting with experts, you can avoid potential compliance issues and maintain transparency.
ECLEVAR experts understand the importance of regulatory compliance for your business and are ready to assist your team with all strategies that were introduced in this article. Contact our team to find out more about the role of regulatory affairs professionals or get help to understand the legal requirements your company or product is subject to. Also do not hesitate to reach out to us if you have any questions about how we use digital solutions in our services.
What You Have Learnt in This Article: Some Takeaway Points
- Regulatory compliance is the process of adhering to laws, rules, and regulations that govern your industry or business. Being regulatory compliant means operating within the legal framework and meeting the required standards.
- Non-compliance may lead to legal consequences, reputational damage, financial losses, harm to consumers, employees, and the environment.
- Some ways to stay up to date with compliance regulations are monitoring changes in the regulations, engaging with regulatory experts and attending industry events.
- Compliance management systems help businesses to identify, assess, monitor, and avoid regulatory compliance risks.
- Compliance audits should be conducted on a regular basis to ensure updated regulatory compliance.
- Training programs for employees should be tailored to accommodate for specific compliance requirements and different job positions.
- It is recommended to make the most of technology to automate compliance processes, enhance data analysis, facilitate monitoring and reporting, and improve overall efficiency.
- Regulatory compliance experts can provide guidance to understand and meet regulatory requirements. They can help with planning and implementing effective compliance strategies.
