Building an effective and efficient compliance program for Life Sciences companies requires more than in-depth insights into compliance operations and risks that the organization generally experiences.
When opting to build an effective and efficient compliance program, There are several aspects to consider because most of them impact the performance of your compliance program.
Government expectations, Jurisdiction, Industry, Therapeutic Area and Guidelines by Regulators – should all be considered while building the foundation of an effective compliance program.
In addition, identifying the situational and circumstantial aspects is also imperative to determine the compliance program you’re building. This is where a significant amount of hard work is required.
Moreover, you need to be clear on the level of compliance program maturity you can achieve with the help of the departments and existing resources.
Once you’ve achieved a certain level of maturity in building an effective and efficient compliance program, you start executing, evaluating, and repeating the overall progress.
Basically, you have to follow the idea of continuous progress as per DOJ’s latest guidance to ensure that your compliance program is robust and evolves as per the latest rules and regulations enacted by the government.
Analyzing Expectations for Effective Internal Controls
Compliance controls should optimize compliance operations within an organization and reduce the efforts generally required in preventing, detecting, and remediating critical business risks.
The guidelines provided by HHS-OIG should be followed to identify key risk areas identified by the government earlier. Then, policies and procedures should be designed to ensure that processes within the key risk areas are compliant – all while detecting criminal conduct.
Here are a few critical areas that compliance professionals should monitor to identify risks before the government does:
-
Interactions with healthcare professionals (HCPs), Organizations (Os), and third-party agents
-
Compliance policies and procedures to balance empowerment and restrictions
-
Business strategy and goals
Moreover, compliance monitoring is essential for evaluating business activities that are taking place internally or externally. The aim should be to ensure that the activities are working as intended and that positive/expected outcomes are being produced.
Leveraging Data to Enhance Monitoring Programs
Making data analytics an integral part of compliance is essential to developing an effective compliance program. Leveraging the data-driven approach enables compliance professionals to tap into the world of compliance data to derive actionable insights that can be utilized to further strengthen compliance operations.
However, certain inefficiencies in data analytics may compromise the overall data quality. Identifying gaps, utilizing accurate data, reducing complexity in compliance monitoring and determining what’s relevant and what isn’t becomes a challenge when you have inefficient data.
Therefore, compliance professionals must eliminate deficiencies before leveraging compliance data analytics to enhance monitoring programs. Here are the deficiencies that compliance professionals should address:
-
Eliminate the probability of non-existent or incomplete mapping
-
Work with a balanced amount of data instead of utilizing too little or too much data to extract insights
-
Data timeliness is critical to ensuring proactive compliance
qordata’s data-driven compliance platform enables compliance professionals to take the complexity out of compliance by piecing the siloed processes together while addressing other issues, resulting in decreased compliance complexity and increased performance.
Life Sciences compliance teams can dive into analytics to derive actionable insights with our compliance data analytics platform.
In addition, compliance monitoring by qordata simplifies live, virtual, and hybrid monitoring for Life Sciences, ensuring that risks are identified and remediated promptly.
Related Article:
