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The modernization of life sciences compliance

A proactive approach to regulations

Compliance modernization is a broad mandate that spans the way the function is governed; the tools, technology, and analytics it uses; the number and nature of its connections to other parts of the business; the expectations assigned to it; and more.​ A modernized approach to compliance in the life sciences and pharmaceutical industry enables business leaders to stay ahead of regulations.

The new imperative in life sciences

The pressures are mounting for life sciences companies from both regulators and patients: increasing regulatory mandates, intense pressure on pricing, and non-stop technological advancements. To thrive and take the lead, business leaders must address the new imperative head-on.

For too long, many compliance professionals have been focused on point solutions and analyzing tactical, transactional data in search of what went wrong. It is time for the compliance function to change its focus from hindsight to foresight and driving insight—teaming with the business to enable business growth. This will require modernization of the compliance function and approaches to compliance.

Compliance and regulatory functions have an opportunity to better align with business strategy and respond to external opportunities/pressure in a drive toward efficiency/effectiveness. Modern compliance organizations are risk intelligent, efficient, and deliver through business partnership and enablement.​

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Outcomes of a modernized compliance program

Drivers for modernizing compliance

Pressure for change is coming from many directions, including internal challenges, emerging technologies, and regulatory pressures.

  • Internal challenges can include lack of executive leadership buy-in, fragmented regulatory and compliance change management, lack of compliance strategic vision, and disparate risk methodologies. 
  • Emerging technologies can include regulatory technology, specifically cognitive compliance, risk sensing, and automation/robotics-integrated governance, risk, and compliance. Big data and analytics, including increased use of unstructured, high-volume data to drive risk identification and process enhancement. 
  • Regulatory pressures can include heightened standards and expectations given size and complexity of operations/services, as well as increased regulatory examination and inspections.

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Plan of action—following a staged approach brings method to the modernization

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