The complex commercial compliance in the life sciences industry demands a combination of technologies, resources, and expertise to assure regulatory adherence.
Understanding regulatory requirements, ensuring adherence to applicable rules and regulations, and mitigating compliance risks associated with different aspects of the business have become challenging.
However, we’ve observed a boom in the compliance-tech industry in the past few years.
Data-driven compliance monitoring solutions have emerged in the market, enabling life sciences to harness the power of data that life sciences companies generate and regulatory authorities publish to:
- Detect compliance risks
- Ensure regulatory adherence
- Create effective key risk indications (KRIs)
- Monitor key risk areas and remediate compliance issues
- Detect policy or process failures before the regulatory authorities do
- Ensure adherence to all applicable laws by leveraging a data-driven approach
The capabilities mentioned above are achieved through insights, and this blog specifically focuses on them.
Today, we highlight the 7 key insights compliance officers can derive through effective compliance monitoring.
The insights on this list empower life sciences compliance programs and enable compliance officers to detect and navigate regulatory complexities, ensuring adherence to laws.
1. Status of Adherence to Regulatory Requirements
This section delves into how, through compliance monitoring, life sciences companies and compliance officers can ensure adherence to regulatory requirements.
By monitoring compliance with laws such as the U.S. Sunshine Act or Foreign Corrupt Practice Act, companies’ guidelines to international standards, maintaining a proactive stance ensures seamless adherence.
Identifying historical and present risks enables compliance officers to ensure that similar compliance issues do not exist in the future and remediate existing risks effectively.
2. Compliance Risk Identification and Mitigation
Compliance risks are a part of the life sciences industry. On the commercial side of things, the stakes are high, with regulatory penalties and fines surpassing the $20 Billion mark since the year 2000.
The next insight compliance officers get by leveraging data-driven compliance monitoring is the identification of potential risks that can escalate to critical levels and pose a significant threat to the organization.
A deep dive into the company’s compliance stature also reveals what strategies (if any) were employed in the past to proactively mitigate the risks, whether they were effective or not, the current regulatory demands, and how compliance officers can safeguard the organization from business-critical risks.
3. Insights Into Your Compliance Program
Compliance programs have evolved beyond a mere checklist. They’ve become an adaptable and dynamic system that enables companies to keep up with changing regulatory demands.
The insights you gather through data-driven compliance monitoring enable you to understand the capabilities of your organization’s compliance program to see if it can identify and remediate risks.
On the contrary, if an organization’s compliance program is outdated and not backed by technologies today, it may lack the capabilities to meet evolving regulatory standards. This failure could lead to dire consequences such as regulatory fines, product recalls, and criminal charges.
To avoid such risks, the organizations need to have a compliance program that is designed to:
- Anticipate changes in the regulatory landscape and take steps to address them before they become problems.
- Focus on the areas where the company is most likely to have compliance issues.
- Support, evolve, and change as the company and regulatory demands grow, evolve, and change.
- Utilize compliance data to identify, track, and remediate compliance risks.
By having such insights into the compliance program, compliance professionals can ensure that the program is designed to meet evolving regulatory obligations and protect the company from critical risks.
4. Compliance Process Efficiency
Compliance processes are essential but there are times when they become cumbersome if not timely updated.
This leads to ineffectiveness and hinders the compliance program’s agility, performance, and resilience.
Having effective compliance monitoring controls in place will enable you to get insights into process failures and update and optimize processes to ensure effectiveness. Jo
Here are a few insights that you will get through compliance monitoring for optimizing your compliance processes:
- Bottlenecks: Are approvals taking forever? Are repetitive tasks draining employee time? These roadblocks, once identified, will enable you to streamline workflows, automate repetitive tasks, and optimize resource allocation.
- Data-Driven Decisions: Leverage data analysis from monitoring to make informed decisions about process improvements. Are certain controls overly burdensome? Are specific departments struggling with compliance tasks? This data paints a clear picture, enabling you to effectively prioritize improvements and target resources.
- Risk-Based Targeting: Shift from a reactive to a proactive approach. By analyzing historical data and identifying areas prone to compliance risks, you can focus resources on high-risk areas instead of all aspects of the organization.
- Cost Optimization: Efficient compliance processes translate to cost savings in the long run. Reduced rework, faster completion times, and fewer compliance issues contribute to leaner operations. Monitoring helps identify waste resources and opportunities for cost optimization, allowing you to do more with less.
Such insights gained from compliance monitoring can transform the overall stature of compliance within your organization, making it easier to ensure that robust processes are in place to regulate its compliance.
5. Gauge Employee’s Compliance Awareness
Regulatory authorities such as the U.S. Department of Justice (DOJ) have made it clear in their compliance program guidance to ensure that employees are aware of all the applicable compliance requirements.
Compliance monitoring enables you to monitor high-risk employees such as sales representatives, third-party interactions, and more and assess whether the specific employees are aware of compliance requirements.
Once the individuals or the department where compliance knowledge is lacking is detected, compliance officers can implement targeted training programs to cultivate a compliance-centric culture.
The multifaceted approach to fortifying employees’ compliance knowledge would ensure risk mitigation, build employees’ awareness, and understand the totality of risks the organization faces.
6. Third-Party Vendor Compliance
Collaboration with third-party vendors is common in life sciences.
For innovation, research, educational purposes, or for the betterment of the healthcare industry, life sciences companies must engage HCPs.
As easy as this may sound, this area is highly scrutinized by the government. It is one of the areas where compliance violations could easily escalate to critical levels that would result in devastating consequences.
In this segment, utilizing compliance monitoring would shed light on how compliance officers extend their vigilance beyond the organizational boundaries, monitor third-party compliance, detect risks as soon as they occur, and implement remediations to ensure compliance with all applicable rules and regulations.
7. Insights into Ethical Considerations
Upholding ethical standards is more than an imperative. It’s the foundation of building trust in regulators and ensuring compliant long-term success.
Enter compliance monitoring, a critical tool that highlights potential ethical gray areas. Rather than just ticking boxes, it delves deeper, examining the “why” behind adherence and unearthing the ethical implications of decisions.
Continuous evaluation of compliance processes enables compliance officers to detect areas where ethical considerations might be missed quickly.
Imagine ensuring informed consent in clinical trials, safeguarding patient data, managing conflicts of interest, or adhering to ethical marketing practices.
Compliance monitoring doesn’t stop at detection; it cultivates a culture of integrity. Through transparent communication, training, and open dialogue, employees are empowered to make ethical choices and raise concerns.
Ultimately, it all boils down to compliance monitoring being more than just checking boxes.
It’s the proactive champion of ethical standards in the life sciences industry. Illuminating potential risks and fostering integrity empowers organizations to make responsible decisions, build trust with stakeholders, and ensure sustainable success.
Conclusion
Monitoring emerges as a beacon of insight in the ever-evolving landscape of life sciences compliance. This blog has addressed all the seven critical insights compliance officers discover through data-driven compliance monitoring.
Leveraging these insights, life sciences compliance professionals can navigate compliance challenges, foster a culture of integrity, and lead their organizations toward sustained success.
Above all, they can demonstrate regulatory adherence to the government, save their reputation from damage, and ensure compliant business growth.
