Compliance in 2024 is at a crossroads and life sciences companies are facing critical decisions that will shape their future direction in response to the evolving regulatory demands.
Companies have had success in implementing the ‘7 Elements.’ However, very few have had success in developing an AI-driven compliance monitoring program.
Advanced compliance monitoring in life sciences enhances the compliance function, allowing professionals to proactively detect and mitigate risks early on.
Monitoring capabilities also include the centralization of life sciences compliance data to capture and evaluate information from various commercial areas and report issues back to stakeholders, allowing for timely investigation and risk management.
Global Compliance Monitoring: Explained
Compliance monitoring is the process of identifying, managing, and mitigating risks associated with various activities and areas within a life sciences company.
Compliance monitoring allows life sciences companies to timely remediate risks before they escalate to critical levels.
Through global compliance monitoring, life sciences organizations not only monitor risks but also get the ability to evaluate the effectiveness of their current compliance processes and how well they are designed to meet regulatory demands.
Monitoring Compliance Programs & Compliance Professionals
In the life sciences industry, compliance professionals play a key role in tracking and monitoring all commercial activities. Their responsibilities include evaluating the effectiveness of the organization’s compliance monitoring program in identifying potential risks.
In the modern world of life sciences compliance, professionals face a choice: they can either manually implement compliance monitoring strategies or leverage advanced compliance monitoring platforms.
The latter provides a more robust approach to monitoring compliance, allowing teams to leverage technologies such as AI, OCR, Computer Vision, Data Sciences, and Machine Learning to automate their compliance monitoring program.
This empowers the compliance teams to work more efficiently and effectively.
Moreover, given the increased scrutiny, heightened expectations, ongoing changes in regulations, and pressure from regulatory bodies, utilizing compliance monitoring software is imperative for life sciences companies looking to assure compliance at all levels.
The shift to an advanced compliance monitoring solution enhances monitoring capabilities and augments the compliance monitoring program’s capabilities, assuring effective risk identification and remediation.
Laying the Foundation of Effective Compliance Monitoring in Life Sciences
The foundation of your compliance monitoring plan starts with comprehensively analyzing and reviewing the totality of risks that your life sciences company faces.
Streamline the areas that are prone to risks, which have historically been proven to be risky, and where cases of non-compliance have been reported.
Areas, for instance, can include consulting agreements and off-label promotions, while activities can involve speaker programs.
Get clarity and insights on the status of your compliance monitoring program and compare it against the applicable rules and regulations enacted by regulatory authorities such as the Office of Inspector General (OIG) or the U.S. Department of Justice (DOJ).
Through this, you will be able to determine gaps in your existing compliance monitoring plan and see if you need compliance monitoring services or AI-powered compliance monitoring tools to monitor such risks and ensure regulatory adherence.
Moreover, the risk of policy violations can be higher in some areas as compared to others. Therefore, analyzing historical and real-time data to determine high-risk areas in your organization and then allocating resources to avoid the risk of non-compliance can be a benefit of this study aspect of your overall compliance monitoring strategy.
To enhance a compliance monitoring program, start by measuring the effectiveness of your current life sciences compliance management and monitoring process to identify areas for improvement.
Analyzing compliance data generated can provide valuable insights into the effectiveness of the current compliance monitoring workflow, helping you boost efficiency and assure better risk detection and remediation.
Moreover, automation significantly adds to the effectiveness of your compliance monitoring process, making it more efficient.
As compliance requirements become increasingly complex, automation allows teams to streamline manual laborious tasks, increase accuracy and efficiency, and assure increased risk detection and mitigation.
Listing Down the Benefits of Real-Time Compliance Monitoring
Key benefits of compliance monitoring software include the following:
These features powered by advanced technologies empower compliance officers to manage risks effectively and augment the capabilities of the compliance management system, transforming it into a proactive compliance monitoring process that addresses risks as soon as they are detected.
Since compliance monitoring is a regulatory requirement, leveraging advanced compliance monitoring solution enables compliance officers to demonstrate commitment to compliance to regulatory authorities.
Download the case study to see how qordata’s Global Compliance Monitoring solution helped a reputable medical drug manufacturing company by enhancing compliance monitoring and risk profiling.
What Makes Global Compliance Monitoring a Priority for Leaders?
Compliance monitoring provides compliance leaders visibility into an organization’s compliance activities.
It allows them to identify underlying risks that are prone to human error or often go undetected during manual analysis, enabling them to assess whether activities are being conducted in compliance with regulations.
A compliance monitoring platform enables compliance teams to identify areas of risk and noncompliance. Whether accidental, intentional, external, or internal, through compliance monitoring, compliance officers can identify violations and quickly remediate such risks to assure compliance.
Also, putting together an improved compliance monitoring plan is the first step toward improving the entire compliance monitoring program.
With a plan in sight, you will get to understand gaps within your existing compliance monitoring workflow or systems.
This will enable you to deploy or build effective compliance monitoring tools tailored to address risks specific to your organization, enabling your compliance team to overcome challenges associated with their monitoring compliance programs.
To Conclude…
Commercial compliance in the life sciences industry encompasses a wide range of areas, including sales and marketing, operations, finance, conduct, and ethics, and the challenge lies in the constantly evolving regulatory demands and expectations.
This combined with the challenge of siloed data, manual processes, and limited oversight leads to non-compliance, which can lead to devastating consequences such as fines, penalties, regulatory audits scrutiny, and more.
However, leveraging compliance monitoring services or AI-driven monitoring solutions can empower life sciences companies and compliance officers to navigate such challenges and ensure compliant commercial operations.
qordata’s compliance monitoring platform allows life sciences companies and compliance officers to know their risks and do something about them.
It provides the following features to help compliance officers address challenges associated with compliance monitoring:
- Create and track a risk mitigation plan
- Configure and track your monitoring plan
- Stay compliant by monitoring the right reps
- Review highly rated HCPs and speakers
- Measure your compliance stature
- Audit 100% of your expense reports within a few minutes
- Track risk remediations effectively
- State-based monitoring remediation
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