Today’s conventional translation management tools do not support the complex requirement of the intricate regulatory labeling submissions approval process.
Currently, pharma organizations must use parallel manual processes to preserve the history of all changes. These changes then need to be painstakingly and very accurately re-introduced into the final delivery documents. This very tedious manual effort requires costly overhead. Given tight regulatory timelines, this process of re-introduction adds significant overhead to an already challenging process.
It all starts when the central labeling team creates the labeling text using Microsoft Word, the authoring tool most pharmaceutical organizations use as required by most regulators.
This very manual process results in the following challenges:
Negative impact on future label submissions
After re-submission to regulatory bodies, the reviewer again uses the “Track Changes” tool of Microsoft Word to make further comments. As a result of the tight timeframes of the process, these changes rarely find their way back into the automated processes of conventional translation tools. This negatively affects future label update submissions as the new changes will not benefit from previous updates.
Manual re-formatting is time-consuming
Given that no specialized translation management tool is used for re-formatting, the final document needs to be re-formatted when translating directly into Microsoft Word.
No way to compare source from new updated version
Additionally, the inability to review source and translated documents side by side makes analyzing translation changes difficult.
Inability to lock changes causes issues down the road
The requirement to maintain non-changed content exactly as in the original demands the ability to lock segments of the content. This is a feature not generally found in translation management systems.
Translation tasks consume the time of highly paid medical professionals
Under the short timelines demanded for the labeling change process, highly paid medical professionals are often pulled into manual translation tasks instead of managing tasks for which they were hired.
Translation management systems of today cannot handle Microsoft Word based labeling and review procedures
While most industries enjoy lower cost and higher translation efficiencies from using a translation management system, the specialized requirements of the pharmaceutical industry mean that unless they use a system specifically built to support them, they cannot gain those benefits for their labeling process. Today’s translation management systems cannot handle Word-based labeling and review procedures.
Organizations have been forced into an unproductive and time-consuming process that costs more than it should. What is needed is a specialized language translation management system that can handle the complexities of the process and can significantly lower the multilingual workload, improve the quality of the final product, decrease associated costs, and free valuable staff time in managing the labeling process. Pharma organizations need a way to leverage the latest technology to handle the cumbersome and unique needs of the labeling submission process relative to translation and to allow human intervention where needed.
Technology is available to support this process from the ground up. Our regulatory labeling solution delivers flexible linguistic workflows that support all regulatory procedures and reduces overhead by simplifying the review and linguistic quality assurance work required. It tracks the sophisticated changes in the labeling process, as required by regulators, and handles auto-propagation, reducing translation workload, costs, desktop publishing and formatting.