You’re a Quality Management professional. What new tools and resources can help you take your work to the next level?
Compliance and technology are the keys to Quality Management success as they help ensure the quality, safety, and efficacy of products and processes that impact human health.
Compliance refers to the adherence to the laws, regulations, and standards that govern the life science industry, such as those from the FDA, EMA, and other authorities. Technology refers to the use of digital tools, data, and analytics to improve the efficiency, effectiveness, and innovation of life science operations, such as research, development, manufacturing, and distribution.
A modernized approach to compliance in the life sciences and pharmaceutical industry enables business leaders to stay ahead of regulations.
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 Quality Management and Compliance professionals have been focused on point solutions and analyzing tactical, transactional data in search of what went wrong.
Some of the benefits of technology in life science are:
- Compliance helps protect the public health and the reputation of life science companies by preventing errors, fraud, and misconduct that could harm patients or consumers.
- Compliance also enables life science companies to access new markets and opportunities by meeting the requirements of different regulators and stakeholders across the globe.
- Technology helps life science companies streamline and automate their processes, reduce costs and risks, and enhance their performance and productivity.
- Technology also helps life science companies leverage data and insights to drive innovation, improve decision-making, and create value for their customers and shareholders.
Some of the challenges of compliance in life science are:
- Compliance can be complex and costly, as life science companies have to deal with multiple and changing regulations, as well as increasing scrutiny and expectations from regulators and society.
- Compliance can also limit the flexibility and creativity of life science companies, as they have to follow strict rules and procedures that may not always align with their business goals or customer needs.
- Technology can be disruptive and risky, as life science companies have to adopt new and emerging technologies that may not be fully tested, validated, or regulated, such as artificial intelligence, blockchain, and gene editing.
- Technology can also create new ethical and social dilemmas, such as data privacy, security, and ownership, as well as the impact of technology on human dignity, autonomy, and diversity.
Compliance and technology
in life science require a balance between regulation and innovation, as well as a proactive and collaborative approach among life science companies, regulators, and other stakeholders.
Modernizing life science compliance functions and harnessing the power of technology is a complex and ongoing process that requires a strategic vision, a risk-based approach, and a collaborative culture.
Some of the steps that life science companies can take to achieve this goal are:
- Assess the current state and maturity of their compliance operations, and identify the gaps and opportunities for improvement.
- Define the desired future state and ambition of their compliance function, and align it with the business strategy and objectives.
- Develop a roadmap and a business case for modernizing compliance, and prioritize the initiatives and investments based on the expected value and impact.
- Implement the modernization initiatives, such as re-engineering core processes, adopting new technologies, enhancing data and analytics capabilities, and optimizing resource allocation and governance models.
- Monitor and measure the outcomes and benefits of modernization, and continuously evaluate and adjust the compliance strategy and operations based on the changing business and regulatory environment.
Some of the resources that can help validation and compliance professionals working in life science companies in this journey are:
- Modernizing Compliance in the Life Sciences Sector, a Deloitte report that provides a comprehensive overview of the drivers, challenges, and benefits of compliance modernization, and a staged approach to achieve it.
- Modernizing Compliance is a Deloitte brochure that summarizes the key aspects and outcomes of compliance modernization, and the services and solutions that Deloitte offers to support life science companies in this endeavor.
- Compliance technology for the pharmaceutical industry, a Deloitte article that proposes a view of digital maturity to help organizations assess their current state and ambition, and recommend action steps to consider in modernizing their compliance operations.
One of the methods that compliance professionals use to assess the current state and maturity of their compliance operations, and identify the gaps and opportunities for improvement, is the gap analysis.
A gap analysis in compliance is an assessment of the difference between an organization’s current state of compliance and its desired level or standard. It is a process used to identify potential areas for improvement by comparing actual performance with expected performance.
A gap analysis typically involves the following steps:
- Define the scope and objectives of the analysis, such as the compliance domain, the regulatory requirements, the internal policies, and the industry best practices.
- Collect and review the relevant data and information, such as the compliance documentation, the compliance reports, the compliance audits, and the compliance feedback.
- Analyze and evaluate the data and information, using a framework or a tool to measure and score the compliance performance, such as the maturity model, the risk matrix, or the compliance dashboard.
- Identify and prioritize the gaps and opportunities, based on the criteria and the thresholds established, such as the compliance risk, the compliance impact, and the compliance urgency.
- Develop and implement the action plan, to address the gaps and opportunities, such as compliance remediation, compliance enhancement, and compliance monitoring.
A further analysis can help quality management and compliance professionals to:
- Gain a comprehensive and objective view of the current state and maturity of their compliance operations, and benchmark them against the desired level or standard.
- Identify the strengths and weaknesses of their compliance operations and the root causes and effects of their compliance gaps and opportunities.
- Prioritize and allocate the resources and efforts to close the compliance gaps and seize the compliance opportunities, and track and measure the progress and results of their actions.
Additional resources that can help compliance professionals to conduct a gap analysis are:
- Compliance technology for the pharmaceutical industry, a Deloitte article that proposes a view of digital maturity to help organizations assess their current state and ambition, and recommend action steps to consider in modernizing their compliance operations.
- Modernizing Compliance in the Life Sciences Sector, a Deloitte report that provides a comprehensive overview of the drivers, challenges, and benefits of compliance modernization, and a staged approach to achieve it.
- How to Assess Compliance: 6 Steps to Take Today, a VComply blog post that outlines the steps and the benefits of assessing compliance, and the tools and solutions that VComply offers to support compliance assessment.
- Compliance Program Performance Metrics: How to Measure Compliance, a OneTrust blog post that explains why tracking compliance program performance is essential, which compliance KPIs to measure, how to know your program is working, and how to track improvement over time.
- How to Conduct a Compliance Audit: A Guide, a SafetyCulture blog post that describes what a compliance audit is, why it is important, and how to conduct one effectively.
What are the existing processes, tools, technologies, and analytics that you use to develop a roadmap for modernizing compliance? How effective and efficient are they?
Compliance professionals use a variety of processes, tools, technologies, and analytics to develop a roadmap for modernizing compliance.
Some of them are:
Regulatory technology (RegTech): This is the use of technology and data to enable and automate the compliance function. For example, you could use robotics, risk sensing, natural language processing, and behavioral analytics to integrate governance, risk, and compliance.
Big data and analytics: This is the use of unstructured, high-volume data to drive risk identification and process enhancement. For example, the use of data mining, machine learning, and artificial intelligence to analyze large amounts of data from various sources and generate insights and recommendations.
Cognitive compliance: This is the use of cognitive technologies such as natural language generation, speech recognition, and computer vision to augment human capabilities and improve compliance outcomes. For example, the use of natural language generation to create reports, speech recognition to transcribe audio, and computer vision to recognize images and documents can help build a roadmap for modernizing compliance.
These processes, tools, technologies, and analytics are effective and efficient in modernizing compliance because they can:
- Reduce the cost and complexity of compliance by automating manual tasks and streamlining workflows
- Enhance the quality and consistency of compliance by reducing errors and inconsistencies and improving accuracy and reliability
- Increase the speed and agility of compliance by enabling faster and more informed decision-making and adapting to changing regulations and business needs
- Improve the value and impact of compliance by providing deeper and broader insights and recommendations and supporting business growth and innovation
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 Quality Management and 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.
