How Copy&Pasting in Regulatory Affairs is Risking Compliance (and Burning Out Your Team)

In our regulatory affairs world, precision isn’t just important - it’s kind of everything. A misplaced word, a wrong issue date in a standard reference, or an outdated document reference in the GSPR document (ANNEX I) can mean the difference between compliance and costly delays in reviews or registration projects.

Yet, many regulatory professionals are stuck in an endless cycle of manual copy-paste tasks, wrestling with documents like:

• Lists of applied standards
• GSPR checklists
• Clinical Evaluation Reports (CERs)
• Post-Market Surveillance (PMS) documents
• Executive Summaries
• etc.

While it seems like a inconvenience, this repetitive, error-prone process is creating a ripple effect of inefficiency, burnout, and compliance risks.Let’s dive into why this is such a widespread problem - and how you can escape the chaos.

The Hidden Problem with Copy-Pasting

At first glance, copying and pasting data seems simple enough. Need to update the standards list across 20 documents? Just copy it over. But here’s the catch:

1. It’s Exhausting: The sheer volume of documents and data points to cross-check means these tasks eat up hours of valuable time.
2. It’s Error-Prone: Humans aren’t built for repetitive, detail-heavy tasks. A single missed update or misplaced line can have cascading effects.
3. It’s a Waste of Talent: Highly skilled regulatory professionals end up spending their days on mundane administrative tasks instead of strategic work.

How Manual Processes Lead to Errors

Let’s walk through a typical scenario:

• Your team updates the list of applied standards in one document, like the CER.
• Someone manually copies that updated list into another document.
• Meanwhile, the GSPRs hasn’t been updated to reflect the same standards and documents.

The result? Inconsistent documents.

It might seem minor - until it’s caught in an internal audit or flagged by a notified body. Suddenly, that small oversight leads to:

• Costly revisions
• Delays
• Damaged credibility with auditors or regulatory bodies

The Human Cost of Repetition

These errors don’t just affect compliance - they take a toll on your team.

• Burnout: Spending hours on repetitive tasks leaves professionals frustrated and disengaged. (”Did I go to university to have to do something like this?”)
• Cognitive Overload: Constantly double-checking every document increases stress and the likelihood of mistakes.
• Lost Innovation: With teams bogged down by admin work, there’s little room for proactive, strategic thinking.

What’s the Solution? Automation.

The future of regulatory affairs lies in smart automation tools. The tools that eliminate copy-paste chaos and ensure compliance documents are always consistent and up-to-date.

Here’s how automation can transform your workflow:

1. Real-Time Updates Across All Documents: When a list of applied standards is updated, automation tools can sync the changes across every relevant document - CERs, PSURs, GSPR checklists, and many more.
2. Error Reduction: By removing the human element from repetitive tasks, automation minimizes the risk of costly errors.
3. Time Savings: Teams can reclaim hours - if not days - of their time each week, focusing on higher-value work like strategy, research, and innovation.
4. Regulatory Confidence: Consistency across documents builds trust with auditors and regulatory bodies, ensuring smoother approvals and fewer disruptions.

Why Stick with the Status Quo?

If your team is still stuck in the manual copy-paste grind, ask yourself:

• How much time are we losing each week on searching for data/infos and manual document work?
• How many errors are slipping through unnoticed? (And building up over time undercover)
• What opportunities are we missing by focusing on admin work instead of strategic goals?

The cost of staying with outdated processes is far greater than the investment in automation.

Taking the First Step Toward Efficiency

Adopting automation doesn’t mean replacing your team - it means empowering them. With tools that handle the repetitive tasks, your professionals can focus on what they do best: driving innovation, ensuring compliance, and delivering top-quality results.

To do so, your basis should be a content based technical documentation. We have developed a solid data model for our industry over the past 7 years. Delivering a well thought out and notified body tested eTD solution. Covering the whole process. Traceable from content to world wide submissions. Packed with regulatory features to support your daily workflow.

The copy-paste era of regulatory affairs is over. It’s time to embrace a smarter, more efficient way forward.

Are you ready to leave manual tasks behind? Reach out to learn how eTD automation can transform your workflow.