Regulatory Affairs (RA) teams directly engage an increasing number and variety of ‘customers’ – including external business customers, regulatory authorities, and suppliers, as well as internal customers like R&D, marketing, and supply chain.
This is because RA plays a unique role in product transparency and bringing together a holistic product compliance view. In many organizations, RA is best positioned to respond to product compliance requests for information.
However, responding to what can be an overwhelming variety and volume of requests requires advanced digital tools that unify regulatory knowledge and service. RA is often last in line for digital technology, but as today’s businesses race to establish product transparency it needs to move up the priority list.
How Regulatory Affairs Can Prioritize Compliance and Customer Satisfaction
For organizations committed to delighting customers while ensuring product compliance, here are three best practices RA should strongly consider adopting:
1. Become customer centric and track performance
Customer-centric organizations track every (internal or external) customer request and response; they commit to response times, provide regular updates and hold themselves accountable for customer satisfaction. Regulatory teams need regulatory request management tools to be truly customer-centric and these tools should unify requests with regulatory documents and data to maximize consistency, speed, trust and accuracy.
2. Proactively update your regulatory data and documents
Regulatory work can often feel like firefighting. A question comes in and there is a scramble to locate and compile the relevant facts to make a response. In many cases the fact base requires reaching back up the supply chain, generating weeks or months of delays [Source: 2021 Regulatory Management Trends Report]. Moving to a regulatory system of record that tracks all of your data and documents and helps you proactively identify and resolve gaps and expirations provides your organization with compliance confidence and speed.
3. Enable data driven decision making by adopting systems that capture regulatory KPIs
In most organizations, projecting manufacturing costs, business opportunity and R&D investment is far easier than projecting regulatory path to market. The reason is that R&D, Manufacturing and Business typically have fit-for-purpose systems that systematically capture historical results, which informs future projections. In contrast, Regulatory Affairs often lacks such tools, instead relying on disparate ad-hoc tools like MS excel and local file storage [Source: 2021 Regulatory Management Trends Report]. Organizations that invest in modern regulatory management systems can track every step in the regulatory compliance process, and provide clear metrics on performance and gaps which drives efficiency and continuous improvement.
Getting Started: Your Customer Centric Regulatory Affairs Strategy
About the Author
Andrew Douglass, strategy director at Veeva Systems, has a passion for organization and customer centricity. He has been reshaping product teams in the consumer goods and chemical industries to be more efficient, responsive, effective and impactful for 20 years.