Regulatory Affairs’ Quest for a Single Source of Truth


The customs officer looks down at her paperwork again. “I’m telling you, the certificate of free sale doesn’t match the product label. I can’t release this shipment,” she declares. 

The news travels back to regulatory affairs, who swear every document was accurate. Then someone in marketing realizes they forgot to circle back to regulatory when they added the hyphen to “All-Day Moisturizer”. You can almost hear the groans, as people from various departments begin the tedious, time-consuming process of rectifying this mistake.

Regulatory: A Catch-all for Critical Product Information

As a business function, regulatory is the “source of truth” for both internal stakeholders and regulatory authorities. We provide relevant authorities with product, formula, claims and product artwork to approve for distribution. And as demonstrated in the story above, there is no room for even the smallest discrepancy. 

Discrepancies between submission information and the product on the shelf can result in invalid regulatory authorization, leading to possible scrapping of inventory, relabeling product, or even a voluntary recall. All of these outcomes are costly and highly impactful to business and customer relationships.

Most countries require various information on product variations (shades, sizes, kits, etc.), formulas and product artwork. And that’s just a few examples. Regulatory relies on information provided by other functions from marketing to R&D. We may consult an “approved” product label from marketing to extract the product name and claims. Product sizes and country of origin may come from spreadsheets. 

This puts the onus of accuracy on us, as regulatory professionals, to ensure there is only one source of truth, and that it’s accurate. 

Chasing the Truth

Working in regulatory affairs, chasing the truth is a frequent and likely time-consuming element of the job. 

Where is the product name? Which file is the final label artwork? How do I know if the listed countries of distribution are final? How do I know if they decide to release another product size, or change the manufacturing country? What if the product is updated after I pull the information for my submission? Will they remember to notify regulatory? 

Not only does regulatory chase information, but we also validate the accuracy of the documents and data we collect. No amount of reassurance can prevent the inevitable change in direction before launch. Often the onus is on us to make sure there are processes in place to ensure we are notified of changes, and are able to get authority approval, prior to launch. 

The weight of accuracy is on our shoulders. Shipping clearance, compliance, and ultimately protecting our brand image, is our responsibility. Because if or when things go wrong, we are ultimately accountable.  

Regulatory Information Management Best Practices

For the benefit of your colleagues and organization, I encourage you to advocate for these three regulatory information management best practices and establish a single source of truth for regulatory information.  

  1. One source of information across all functions. Leave behind the inherently risky common practice of relying on internal spreadsheets. 
  2. Practice “locking” final key decisions. Key information such as product name, size, country of origin, claims, product label need to be “locked” when final, and require an approval process if any changes occur. Updating spreadsheet trackers should not be used to manage critical information and approvals.  
  3. Include Version control on documents currently housed in various locations to avoid submission of preliminary test data or product labels. This also protects against misrepresenting claims to the authorities with preliminary data or sending in the wrong version of the product label. 

Ultimately, regulatory affairs is responsible for ensuring the data and the documents that support a product registration accurately represent the product on shelf, in each country. Accuracy of information is critical, to avoid costly and high-impact delays. Robust cross-functional processes that help ensure “one source of truth” are the important first step to enable the accuracy of information. 

Learn more about how one company used regulatory information management best practices, and modern regulatory solutions to establish a global authoritative source for regulatory compliance and product information.

Updated on January 1, 2021


veeva logo