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Challenges with Labeling Content, QC & Tracking – The Way Out


The complexity surrounding labeling often leads to errors, product mix-ups, and even misbranding. Labeling being an integral part of the quality management system, such errors often lead to product recalls which might have a negative impact on both the image and the finance of the company. The best way out of this might be through digitization and automation. Moreover, as the current scenario asks for remote working, this turns out to be the new normal.

Labeling Content Challenges

Latest studies have shown that labeling content accounts for almost 33% of the product recalls. Some of the challenges are:

  • Delays in safety changes submission
  • Delay in availability and updates of label superseded version and patient information
  • Updating delays in national labels from core data sheet
  • Issues with review and approval of Label change request
  • Failure to timely update safety information and comments from Health Authorities
  • Challenges with local and global RA teams’ priority issues

Labeling Automation and Digitization Tool

Content Management & Lifecycle Automation

Manual labeling and comparison of documents is a laborious task and due to the number of documents, the chances of error are quite high. Hence, automation will not only assist you in reducing errors but also is beneficial in managing the content and updating them within a given time frame.

Managing CCDS

Company Core Data Sheets (CCDS) need to be reviewed, edited and updated with time and this process generally needs to be automatic as the data becomes innumerable at the regional level. Automation tools help you in the version management to ensure regular updates.


Choose a tool that has in-built local and foreign country regulations. This will allow you to have a comparison of the labels and understand the violations so that there is no need of any future manual reconciliation.

Generating Reports

Report generation helps in global marketing and a tool can easily support you in generating labeling change reports related to administration, safety, compliance, version, and HA updates.

Formatting, Reviewing and Publishing

Modern tools can ensure comparison of documents of various formats. Moreover, a tool reviews any document 75% faster than in manual QC. All HAs have a different labeling format and to maintain that manually is difficult. If you can take the help of a tool with all such inbuilt data then it can make the task easier. The labels get published through automation in the desired format leaving a lesser scope for formatting issues.

Digitization and automation can give you the much needed results and let you move ahead towards an error free labeling and thereby preventing the repeated recalls and ensuring a proper approval.

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