Regulatory fines can be as much as 30% of total EU revenue.
Since implementing our Digital Asset Assurance portal, the company has undergone more than 12 external audits, during which time not a single negative audit issue has been found.
Digital Governance Manager
Our client, a Top 5 global pharmaceutical company, has thousands of web pages, images and PDF documents online in more than 40 different languages. The company ensures that its online content is accurate and compliant with regulatory requirements at the point of creation and distribution, but unless it is actively managed and updated, certain information – such as Summaries of Product Characteristics (SPCs), dates of preparation, Adverse Event (AE) reporting procedures etc – can easily become out of date. Company policy is that digital properties must therefore be regularly audited to ensure continued compliance, but their previous approach, whereby each page, image or PDF
would have to be identified and searched through manually, was tediously slow and eye-wateringly expensive. Once found, the search results would then be sent to content owners in a complex spreadsheet that was difficult to work with. Perhaps not surprisingly, response rates were less than 25%.
Of greater concern, the manual process was very prone to human error. Potentially ‘problematic’ content could include anything from privacy notices, legal notices and adverse event reporting links down to individual phrases, dates, telephone numbers, addresses, URLs – and even single words. The fact that these could be buried deep within a document or a PDF – or even hidden away on a packshot within an image file – meant that the company was searching globally for an unknown number of microscopic ‘needles’ within literally thousands of ‘haystacks’.
The risk of exposure to regulatory censure, fines of up to one third of total EU revenue, and significant reputational damage was real.
Responding to the challenge, Digital Control Room created a bespoke Digital Asset Assurance (DAA) Portal. This fully automated system penetrates and scrutinises thousands of the company’s online assets and can access web pages, PDFs and even image files. It can hunt for any element, including notices, links, document IDs, dates, phrases and single words while the Machine Learning (ML) model categorises data, reduces false positives and entirely eliminates the need for manual review. The DAA Portal is fully integrated with our client’s enterprise platforms to ensure continuity of ownership and adherence with standard compliance reporting procedures. Dashboards are available to global regulatory and compliance teams giving them a deeper level of insight while content owners receive, review, and respond to real-time compliance alerts.
Where previously annual audits took up to 6 months, Digital Control Room’s DAA portal produces results in less than two weeks, and our client can now run quarterly audits identifying, categorising and analysing approximately 15,000 documents out of hundreds of thousands of web pages.
Increase in regulatory compliance
Avoidance of regulatory disruption, reputational harm, and financial penalties
75% decrease in production expenses
Single source of truth for digital operations excellence
Before implementing Digital Control Room's DAA portal, any red audit from an external body would lead to a mad scurry to fix the identified missteps and avoid reputational harm and financial penalty. Since the portal has been implemented, our client has undergone more than 12 external audits, during which not a single negative audit issue has been found. The system has made the company far more agile in identifying online content that needs addressing, guiding them to take swift, coordinated action.
Timelines have been shortened, costs have been slashed, productivity has been boosted, and regulatory compliance has been significantly enhanced. The system is core to their standard compliance reporting procedures and is a vital tool for their global regulatory and compliance teams by integrating numerous corporate and IT platforms and providing informed insight into the company’s digital footprint and associated risks.
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