7 Reasons Why You Need Regulatory Tracking Software in 2023

In 2023, regulatory tracking software will no longer be a luxury – it will be a necessity. Let’s look at seven reasons why you need it and how it can set you up for success.

Why You Need Regulatory Tracking Software

Pharmaceutical labeling is a critical function, but tough to manage on a global scale. This is because regulatory processes around the world are complex and ever-changing. So, pharma companies need a reliable way to track differences between and changes to labels in every country their drugs are marketed. This is where regulatory tracking software comes in. 

Regulatory tracking software shows pharma companies what’s happening in real-time so they can react appropriately and stay in compliance.

Some pharma companies try to get the job done with Excel, but keeping an audit trail and following compliance in spreadsheets is hard. So, if you haven’t already shifted to regulatory tracking software, 2023 is the year to do so. Here’s why.

1. Custom PSMF Reporting & Other Regulatory Reports

Pharmacovigilance System Master File (PSMF) reporting is something every pharma company needs to ensure compliance and keep tabs on their safety data. But because there’s no out-of-the-box PSMF report, you need a tool that can recreate your own custom report.

Regulatory tracking software helps you improve your product’s safety profile and avoid potential financial penalties by tracking safety data so you can identify potential safety issues and take steps to address them. It generates custom PSFM reports, as well as other regulatory reports, with ease. This ultimately saves you time, money and headaches.

2. One Single Source of Truth for All Your Data

When your label registration data lives in multiple siloed systems, it creates safety and regulatory challenges. Things can slip through the cracks, and meeting label or audit requirements becomes nearly impossible because the data systems don’t interact well.

Regulatory tracking software acts as a central repository that integrates with all your other tools to help you visualize and take advantage of all your label registration data. This data includes country dependencies, artwork information and other relevant data points. Looking at all the data in one source allows you to visualize and take advantage of all your registration data more efficiently.

3. Task Automation

Task automation allows you to manage a global view of how your labeling process progresses worldwide. Two of the most common automations are:

  1. Event-triggered alerts 
  2. Automated country dependencies

Event-triggered alerts are automated processes to help your team communicate with each other and regulatory authorities. 

For example, let’s say a country enters a specific date for when a task is due. You can set up a “Days Until Due Date” automation to alert the team member that they have an assignment due in so many days. This helps your team stay compliant and meet tight deadlines.

A country dependency means one country can’t do work until another country completes its task first. 

So, for example, Argentina may wait to approve a label until the United States does.

Another example of how automated country dependencies help you save time is by automatically notifying other countries that a label change is coming. Instead of manually emailing hundreds of people, you can leverage your regulatory tracking software to do it for you.

4. Less Human Error

With regulatory tracking software, many tasks are automated and predetermined. Since there is less manual work, there are fewer mistakes. And even when manual work is necessary, the software provides an efficient way to get it done quickly and correctly.

For example, quick entry can help your company easily implement a core datasheet change in multiple countries. Instead of going into every individual record, quick entry improves the efficiency of data entry by entering data into records without conducting individual searches. It also allows you to clean up data, which ensures your labels will be up-to-date and compliant.

5. KPI Tracking

Key performance indicators (KPIs) are critical from a compliance and risk perspective. For example, let’s say you discover your drug has a life-threatening adverse reaction and must submit a safety change. With regulatory tracking software, you can track every step of the process to see when and how long it took to update the label.

So, when an auditor comes in and asks to see whether your team followed standard operating procedures (SOPs) according to internal KPIs, all you would need to do is choose the correct priority or indicator and run a report that shows all the KPIs.

6. Audit Trails

Transactional audit trails allow companies to see when an employee made a change, and why, which auditors will look at when reviewing records for compliance. Regulatory tracking software makes it easier to report if a change to a label was submitted or implemented on time.

For example, let’s say that a market had a change where they needed a timeline deviation (changing their submission due date from the standard SOP). An audit trail would show who requested the change and the date and time stamp of when the change was made. Using an audit trail saves you the trouble of looking for the emails that requested the timeline deviation change and provides a centralized repository to review tracking changes and handle audits.

7. Customer Service

Another added benefit of regulatory tracking software is the customer service that comes with it. The ability to ask questions, diagnose issues, and offer recommendations is valuable because it gives your team the help they need to work efficiently. Most solutions even offer a comprehensive help center and chat function to provide real-time answers to timely questions.


Regulatory tracking software empowers pharma companies to track label changes more easily and effectively. Its features – custom reporting, a central repository, task automation, quick entry, KPI tracking, audit trails, and customer service – help regulatory teams make sense of their data and keep their projects under compliance.

Tracking Portal by Intagras is a regulatory tracking solution that allows you to track label changes all over the world. Get real-time insights on your label approvals and make necessary adjustments quickly. Contact us to learn more.

Need regulatory tracking help? Talk to us.

Have questions? Need more info? Talk to one of our experts or request a demo of our Tracking Portal today.