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.
However, 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 localize products for new markets, which involves more than just translations, but also adjusting elements like color, date formats, units of measurement, and artwork.All content like leaflets, cartons, inserts, and legal documentation must also be fully adapted, creating challenges for regulatory teams when combined with the speed at which products must be released.
An easy way to overcome the challenges of placing medical products on shelves worldwide, is to implement effective solutions that ensure the accuracy of products, for all markets and consumers. One technological solution that can help quality assurance teams achieve this, is automated proofreading software.
What is Automated Proofreading?
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 automated proofreading technology, 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, automated proofreading software 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 are 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, automated proofreading 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.
Why Automated Proofreading Technology?
Regulatory industries are abundant with complex documents, extensive regulations, and critical content. Any mistake, no matter how small, can have far-reaching consequences, from costly delays to serious compliance issues. That's why automated proofreading software has become indispensable in this highly regulated domain.
Here are only some ways this software can help quality assurance teams in highly regulated industries:
Ensuring Compliance
Regulatory affairs professionals are responsible for ensuring all documents, content, and submissions meet the stringent requirements set by government agencies, such as the FDA or EMA. Failure to comply with these regulations can result in severe consequences, including product recalls and legal actions. Automated proofreading software helps catch errors, inconsistencies, and content issues that may lead to non-compliance. They act as a safety net, reducing the risk of costly regulatory violations.
Reducing Human Error
Even the most experienced regulatory professionals can make mistakes when reviewing extensive documents. Manual proofreading is not foolproof, and the risk of human error always exists. Automated proofreading software eliminates this risk by inspecting documents for errors and inconsistencies, thus improving the overall quality of regulatory submissions.
Time Efficiency
Regulatory submissions often involve voluminous documents with tight deadlines. Manual proofreading can be time-consuming, slowing down the review process and potentially delaying product approvals. Automated proofreading software allows you to compare documents at rates as high as 1000 characters per second while also ensuring the integrity of your work. This means documentation that would take hours, or even days, to proofread can be completed within mere minutes through this lightning-fast technology.
Consistency in Terminology
Consistency in terminology is critical in regulatory affairs. Using different terms or phrases to describe the same concept can lead to confusion or misinterpretation. Automated proofreading software can help maintain consistency in terminology throughout documents, ensuring clarity and preventing any misunderstandings.
Improved Document Formatting
Regulatory submissions often come with strict formatting requirements. Ensuring that documents adhere to these guidelines is crucial. Automated proofreading software can detect formatting errors, such as incorrect font usage, inconsistent spacing, or improper margins, ensuring that documents meet the prescribed formatting standards.
Scalability
As regulatory affairs professionals are tasked with managing a growing volume of documentation, scalability is a critical concern. Proofreading software can not only inspect individual documents and pages, but it can also inspect large, multi-page documents along with large volumes of content in a fraction of the time. Expect automated proofreading software to easily adapt to increasing workloads, making it an ideal solution for a field where the demand for accuracy and efficiency continues to grow.
Document Version Control
Keeping track of multiple versions of documents is a common challenge in regulatory affairs. Automated proofreading tools can help manage document version control by highlighting the changes and differences between versions, ensuring that the most up-to-date and accurate information is included in submissions.
Handling Multilingual Documents
In the globalized world of regulatory affairs, documents are often required in multiple languages. Translating complex regulatory content can be challenging and prone to errors. Automated proofreading software equipped with multilingual capabilities can identify issues in translated documents, ensuring that the content remains accurate and compliant in all languages your organization requires.
Foreign Languages & Data Compliance
Managing content in foreign languages is a specific 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.
Along with accurate foreign translations, following compliance and data integrity, guidelines are essential in the pharmaceutical industry. Automated proofreading software utilizes 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.
The Ultimate Solution: Automated Proofreading
As the nature of regulatory standards continues to evolve, so does the need to effectively implement technology solutions such as automated quality control. These technology solutions not only improve processes between teams but 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, head over to our demo center to learn more about our innovative proofreading software and see how this technology can revolutionize your everyday business practices, at your own pace.If you are looking for a cloud-based solution, transform your quality control processes with GlobalVision’s cloud-based quality inspection tool, Verify.
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