Documentation Dilemma, Part 1: Why Can’t I Just Use AI on Its Own?

The rise of AI is impossible to ignore. For starters, it’s already transforming the pharmaceutical industry and enhancing everything from research to patient care. But when it comes to documentation, AI alone isn’t enough.

Documentation — a critical component of the life sciences sector — is not yet ready to rely solely on AI. Especially, without a structured content management solution like Docuvera to avoid the pitfalls that compromise efficiency, accuracy, and compliance.

What is a structured content management solution?

Before exploring the reasons AI is not yet ready to cover the whole documentation process unsupervised, let’s clarify what we mean by structured content management.

Structured content management is also sometimes referred to as structured component authoring (SCA). Documentation content is created as components in a solution designed specifically for medical writers, reviewers, and approvers. Ideally, the solution’s interface is familiar — like a typical desktop publishing program — but the publishing process is optimized. Component reuse enhances productivity, efficiency, and communication.

If designed specifically for pharmaceutical use, a structured content management solution can improve the efficiency of document creation, minimize errors and omissions, and provide compliance necessary for this regulated industry.

Why can’t I just use AI on its own

Across industries, we’re already seeing the impact of AI. But, there are a few reasons why the life sciences isn’t quite ready to go all in. Here’s why:

1. Migration is a complex process

Migrating to an AI-integrated system isn’t straightforward. It takes a well-thought-out plan. Similarly, transferring data from old systems to new ones requires careful strategy. And in the highly-regulated life sciences, there is a lot of information you need to move, carefully, which means considering data integrity — every piece of information must be preserved and protected.

Additionally, documents need to be broken down into reusable parts to organize and manage data more effectively. A structured content solution ensures data integrity. And, it can lay the groundwork for efficient document management.

2. Keeping it consistent is a constant challenge

Pharmaceutical documentation needs to be consistent, even when updates are involved. AI can help with this, but it needs the right setup. Not all authoring platforms — especially outdated desktop publishing ones — are designed to adapt to the new functionality that AI offers.

The right structured component authoring management platform can support:

• Reuse of validated content by ensuring documents stay accurate and compliant.
• Uniform content updates when changes need to be reflected across all related documents.
• Efficiency when updating approved content to multiple places

Without proper content management or a solution in place to add control, inconsistencies can arise and affect the quality of your documentation.

3. Tracking changes, versioning, and audit trails, oh my!

In pharmaceuticals, knowing who made changes and when is essential. This industry depends on versioning and audit trails; AI alone can’t handle this. A structured content management system can keep a history of all document revisions and track changes to provide transparency, even if it leverages AI for certain functions. A solution with these features can help during inspections and audits, ensuring compliance with regulations.

4. Human oversight is key for review and approval workflows

AI can streamline workflows, but it can’t replace human expertise. In documentation, the review stages involve multiple stakeholders, including experts and compliance officers. While AI might be able to  automate tasks, approval workflows require human oversight for accuracy. Because ensuring documents are thoroughly vetted is so critical for maintaining high standards, this part of the documentation process cannot be left to AI on its own.

Docuvera is the solid foundation AI needs

AI is a powerful tool but isn’t a standalone solution. For effective pharmaceutical documentation, AI needs to be integrated into a structured content management system. At Docuvera, our approach ensures efficiency, accuracy, and compliance. By combining AI with robust content management practices, organizations can fully leverage the benefits of AI while maintaining high standards.

Stay tuned for part two of this series , or download our whitepaper, AI + Structured Content: A new era of pharmaceutical documentation.