6 Steps to Modernize your
Compliance Monitoring Program
Knowing your risks and doing something about it
Our Team
Jim Dawson (SME)
30 years-experience, established and led compliance programs as compliance officer.Thought leader within the compliance space.
Mohammad Ovais (Entrepreneur)
23 years of experience of implementing technology for clients across North America.Known speaker at compliance conferences and webinars.
Salman Kasbati (Orchestrator)
22 years of experience providing software solutions. Served oil & gas, life sciences, financial institutions across the US and EMEA.Known for planning and execution.
Why qordata?
Since 2009, qordata has been serving the life sciences industry with our data-driven compliance solutions, with the sole purpose of serving humanity through meaningful technology solutions.
We have worked with 55+ life sciences clients with an industry-beating NPS of over 70%.
Our passion is to strive towards our vision of compliance teams leveraging technology and data to operate with increased effectiveness and efficiency in running their compliance programs.
We empower the compliance teams with leading edge data-driven solutions, blended with our in-house compliance expertise of 100+ professionals spread across 4 different time zones.
Penalties And Reputational Risks Await
Total penalties from compliance-related violations have crossed over US $20B since 2000
73% of compliance officers indicate increasing regulatory expectations and scrutiny with boards as well as regulators as the top two sources of pressure
Conventional Compliance Monitoring
- With limited team members and budgets, compliance officers do what they can to carry out risk assessments and monitoring activities.
- Access to data is difficult and disparate systems result in not knowing where to find it, data isn’t easy to access OR too much data to analyze.
- Gaining visibility to compliance concerns and risks is limited because connections between risk assessments, mitigation plans and monitoring is weak due to utilizing manual processes and vendors.
- At best, 30% risks are effectively managed, which leads to increased board scrutiny and exposure to investigations and penalties.
Data-Driven Compliance Monitoring
- Using data-driven approach, combined with AI, compliance officers effectively implement risk assessments and monitoring activities with limited headcount.
- Utilize AI and advanced analytics for comprehensive risk insights and foster seamless collaboration across departments, ensuring smooth data sharing and minimal resistance.
- Risk coverage can increase to more than 90%, mitigation plan created and connected with the identified risks that then connect with monitoring activities for accurate traceability.
- Automated audit of expenses can lead to 100% coverage of audit thus reducing workload and errors.
Develop and implement your risk assessment strategy
- Define the process and the approach
- Identify key stakeholders and team members
- Determine and acquire resources necessary to conduct risk assessment
- Leverage AI-powered risk assessment tools to analyze vast amounts of data efficiently, enabling more accurate identification and prioritization of risks.
- Explore utilizing machine learning algorithms to automate the evaluation and prioritization process, enhancing the speed and accuracy of risk assessment.
- Is there a need for an external service provider?
Leverage AI to Identify and prioritize your high risks
- Considering the stage of the organization, the growth goals and compliance program maturity, identify key risk
- Determine the scope of the risk identification, geographically, and/or divisions or functions
- Incorporate AI algorithms to analyze historical data and identify patterns associated with high-risk activities or areas, assisting in the prioritization process.
- Use AI predictive analytics to forecast risks, aiding in understanding the company's risk capacity and tolerance.
Define your risk mitigation strategy
- Determine the risk management strategy the company is going to formulate for each identified risk i.e. accept, transfer, avoid, or mitigate
- If it is determined the risk is to be mitigated, assign risk owner
- Identify key associated activities and process associated with each risk
- Develop a risk mitigation plan of each risk including CAPA approach
- Identify key partnerships and team members within the organization that can help with the mitigation
Create a risk mitigation plan
- Identify what activities are associated with each key risk, how activities are conducted, which geographic areas and business functions are involved; and when
- Identify what current policies and procedures exist for each risk
- Assign an owner for each risk to be mitigated
- Set a date for each mitigation plan to be completed
- Determine what the key reports need to be provided to whom and at what frequency
- Identify what needs to be audited through which systems
Develop a monitoring plan based on mitigation plan
- Based on risk mitigation plan, policies and procedures; develop a monitoring plan
- Identify what process and systems need to be audited.
- Identify what type of activities will be performed such as live monitoring, analytical monitoring, desktop monitoring, auditing, etc.
- What type of resources, partnerships and key team members need to be engaged.
- Determine what the key reports need to be provided to whom and at what frequency.
- Establish a process to analyze monitoring data that provides actionable insights to effectiveness of mitigation plan.
- Identify type of analytics required to be reported and the level of detail
Analyze data captured from monitoring activities to assess the effectiveness of the mitigation plan and identify new risks.
- Start with the summary stats showing identified risks, mitigation plans and monitoring activities
- Create and review key metrics for each risk based on the monitoring data that indicate whether the risks are being managed or not
- Dig deeper into the data to identify trends, significant outliers or gaps that indicate mitigation plan is working or not towards controlling risks
- Leverage AI-driven analytics to analyze monitoring data in real-time, enabling timely identification of trends, outliers, and potential new risks.
- Schedule regular analysis of all monitoring data and as events dictate
Start your transformational journey with
Compliance Central
We help life sciences companies overcome increasing regulatory and broad scrutiny through our Global Compliance Monitoring solution that automates your monitoring and auditing process to ensure an effective and efficient compliance program.
Global Compliance Monitoring solution augments a variety of your monitoring and auditing activities. The solution offers an aggregated view of your key risks and leverages AI in critical business cases.
Compliance Monitoring & Risk Based Scoring (RBS)
for a pharmaceutical company – a case study
- With the addition of Compliance Monitoring and RBS, the company was able to automate and centralize its compliance processes, enabling its compliance team to monitor and mitigate potential risks efficiently while significantly minimizing challenges related to monitoring and risk profiling
- Digitalization of the selection criteria through Veeva integration
- Automation of checklists for live monitoring with automated workflows to enable cross-team collaboration
- Remediation workflows tailored to internal processes
- RBS (integrated with advanced algorithms) enabled compliance teams to accelerate the speaker’s risk assessment
- Insightful dashboards allowed the compliance team to analyze and track data compared to manual monitoring
Our Team Is On A Mission To Help You!
If you want to increase effectiveness of your compliance program and want to know everything about the potential risks that exist in your organization – let’s jump on a strategy call.
The catch is, if applicable – we might show you how our Compliance Central platform can speed up your plan.
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