Blog
Starting your connected compliance journey in 4 easy steps
Kari Miller, Sr Director, Offering Management
Sue Plant, Director of Regulatory Intelligence at IQVIA
May 20, 2022

While pandemic numbers continue to decline, and as life returns to normal for most industries, life science companies face new challenges – those related to managing both global and local regulatory and quality compliance. There has been a 150% increase in regulatory mandates in the last five years– that is over 23,000 new guidelines – issued annually. That means new or changed regulations are being announced nearly every 22 minutes – how can companies possibly keep up with all of it?

Regulatory and quality compliance teams are struggling to ensure they have the data needed to remain compliant. When these individuals are spending 80% of their days on just data collection, there is little time left to effectively and strategically use any insights that emerge from data analysis. And when multiple teams are gathering similar data it creates a significant inefficiency and overlap in the expense of resources.

Breaking it down

Creating an enterprise-wide view of the regulatory environment by breaking down and connecting information silos among different teams will eliminate issues with disjointed operations. When teams share and communicate, operations become proactive rather than reactive thanks to actionable insights provided by data analysis, reducing risk associated with patient safety, denied approvals, license or registration withdrawals, legal concerns, financial penalties and more. Companies can scale regulatory compliance operations more effectively by leveraging a single source of truth – or information database – for regulatory intelligence. Establishing a single source of truth brings together all the data surrounding regulatory requirements and compliance, including data from external sources of requirements and guidelines and internal sources of precedent and intelligence such as interactions with various authorities.

The result of breaking down information silos via establishing a single source of truth is key teams of clinical, quality, regulatory and safety can effectively share information. The high cost of compliance and regulatory information gathering is distributed between the teams equally as well.

Starting the implementation process

However, it is not as easy as just selecting automated, AI/ML technologies to assist with the gathering and processing of regulatory data across the organization. Connected compliance and intelligence from information sharing only happens when the teams have the right data, with the right insights to make the right informed decision for action.

Companies must invest in new processes and their teams for success. It is a deep cultural shift that must take place across multiple teams to successfully achieve true information sharing and connected compliance. From a cultural perspective, the transition to connected compliance is about training teams to work in more collaborative ways, including joint decision making. Management will need to be ready to guide the process and demonstrate how merge departments and bring together these internal processes. There are four essential steps that can be taken to start creating a connected intelligence platform for regulatory compliance:

  1. Identify the influencers. Start by determining who the key stakeholders most impacted by these changes. Invite them to collaborate and be part of the planning and implementation process from the start.
  2. Define the project. Clearly state the objective and goal of this new initiative and encourage the involved team members to share what data is critical to their needs. By having a clear view into the raw data that needs to be transformed into regulatory compliance outputs, organizations may reduce the risk of any false starts and will more easily sustain the project’s momentum.
  3. Create the shared data source. Developing this single source of truth database will aid in unifying the various departments. The shared information with the updated regulatory requirements will only increase the visibility of information.
  4. Training the full team. Once the shared information is up and running, those influencers who helped define the project now must share their knowledge with their peers. Through internal training sessions, more individuals can be brought in to use this data and embrace the new method of connected intelligence and compliance initiatives.

While a connected compliance initiative cannot happen overnight, it is essential that life science companies begin to take these steps now to embrace a new method of sharing intelligence across the organization.

For more details on how IQVIA can help companies in developing this process and implementing the right technologies, be sure to read our whitepaper and fact sheet here or reach out to speak with our team at Regulatory_Quality_Compliance@iqvia.com.

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