The Challenge
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 can easily become out of date.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.
Of greater concern though, was that 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 were searching globally for an unknown number of microscopic ‘needles’ within literally thousands of ‘haystacks’.
One slip and they could be exposed to greater risk of regulatory censure, potential fines of up to one third of total EU revenue and the huge reputational damage that would ensue.
Regulatory fines can be as much as 30% of total EU revenue
A radical change was therefore needed, and it was against this backdrop that Digital Control Room was charged with developing the solution.
