An illustration of a stairway between 2 structures

Date: July 28, 2020 | Category: Quality | Author: Kayla Caticchio


Now more than ever, the demand for safe and effective medical drugs is increasing on a global scale. This means that regulatory affairs teams are working overtime to interpret, apply, and communicate the guidelines received from governing bodies like the FDA and EMA when it comes to developing new drugs. And when medical drugs are approved, they must then be made available for use on a global scale. As a result, all content must be adapted to meet the legal and cultural requirements of markets beyond the country in which they were produced.

As market sizes expand, pharma companies must coordinate localization for every product they release. More than just translations, this includes adjusting elements like color, date formats, units of measurement, and artwork to reflect various markets. All content like leaflets, cartons, inserts, and legal documentation must also be fully adapted, creating challenges for regulatory teams when combined with the speed in which products must be released.

Technology for the pharmaceutical workflow

A key way to effectively manage the increasing workloads as a result of globalization is to harness technology that allows regulatory affairs teams to operate at scale. When it comes to proofreading, manual processes are no longer efficient given the speed and complexity in which products must be delivered.

With a digital quality control system, proofreaders and RA teams can verify content accuracy on digital files and printed packaging components, eliminating inefficiencies at every stage of the pharmaceutical workflow. To begin, product requirements are submitted to regulatory bodies who then compile the information into briefing documents. At this stage, a digital quality control system would ensure that all copy documents are error-free and accurate for internal revisions.

At the artwork creation stage, artwork files can be automatically inspected to make sure that no errors were introduced during the file creation process. Examples of errors that could be created during this stage include logo errors, incorrect product information, and barcode defects. At the final stage, a digital quality control software can automatically compare approved files to supplier proofs before going to print, ensuring that products make it to market with packaging that is entirely error-free.

Foreign languages & data compliance

Managing content in foreign languages is another challenge for regulatory teams in the pharmaceutical industry. As medical products make their way into foreign markets, all materials and content must be properly translated into multiple languages which creates significant room for error. Technology solutions can help effectively manage this by improving document management, version control, and quality assurance through automated proofreading that supports many foreign languages. 

Along with accurate foreign translations, following compliance and data integrity guidelines is essential in the pharmaceutical industry. Digital quality control tools utilize audit trails and reporting features to track all activities, ensuring compliance with bodies like ISO certifications, 21 CFR Part 11, and Annex 11. These tools help protect data integrity by providing full traceability on who ran an inspection, the inspection results, and what changes need to be made.

As the nature of regulatory standards continues to evolve, so does the need to effectively implement technology solutions like automated quality control. These technology solutions not only improve processes between teams, but they also increase cross-functional collaboration and give pharmaceutical companies the tools they need to operate on a global scale.

To learn more about how technology can help manage regulatory compliance, check out GlobalVision’s guide Digital Transformation for Pharmaceutical Packaging Quality.

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