current landscape & challenges
Evaluating and QCing a global label portfolio requires many facets of expertise and attention to detail. Regulatory departments need to understand multi-country writing conventions and be able to switch and remember over 1,000 checkpoints and the volumes can be enormous. We recently assessed a global pharma company with a portfolio of 30 products being sold in 90 countries. In terms of label QC, they have 5,600 labels to amend annually, work in 50 languages and this adds up to 30,000 hours of QC effort.
When new regulations are introduced, this results in peaks of workload, so being able to handle sudden increases is important. This also means the labeling change process needs to be scalable. Not forgetting that any change in form factor for 14 pill blister packs being changed to 7 pill packs, will require other guidelines and therefore labeling changes.
Finally, it is easy to overlook just how manual and repetitive, and therefore prone to error, label content QCing can be. The higher the volume and complexity being handled the more likely the regulatory team is going to have to watch for errors.
our automation solution
Using a mix of technologies and AI programming tools, we have developed automation software that provides both auto proofreading for formatting and auto proofreading for content. Both methodologies will assess a number of given checkpoints for respective and designated regions on the given document or label.
Freyr's automation solution delivers accelerated QC performance, so much so that in a recent benchmarking test we took a QC process that had manually ran 250+ distinct checkpoints covering labels across 90 countries and took a total of 30,000 hours. With our automation solution, we cut this time down to 9,000 or saved 57% of labeling QC time.
The system will also perform a quality test of the output document, will generate logs and let the user know when it is ready to download the output document.
The system will also perform a quality test of the output document, will generate logs and let the user know when it is ready to download Output document.