EU IVDR Consulting

Data Dictionary

Information Consistency

• Modify entries across all documents with a single update.
• Align data and content across various documents for simplified maintenance using Local and Global Data Dictionaries.
• Predefine commonly used terms such as “Indication for Use” as dictionary entries to ensure consistency.

Automated Abbreviations & Citations

Saving Half The Time

• CAPTIS® automatically creates a list of abbreviations, updating as new entries are added and used.
• The built-in Citation and Reference Manager automates the process of creating citations.
• Eliminates need for EndNote, Mendeley, and Zotero subscriptions.

Content Linking & Traceability

Faster Reviews

Create a CAPTIS^®Link:

• Link to any content or information from a source document, such as an IFU.
• Maintain traceability and save time when verifying report content. Quickly navigate to the original source documents to breeze through content verification.

Stay Aligned with Collaboration & Review

Team Alignment

• Work concurrently on various projects.
• Communicate with your team and update project status with comments and responses.
• Assign roles and responsibilities with customizable review.

Inserting Automated Literature Report

Reduced Errors

• Leverage automated, ready-to-use literature reports to present various elements from your literature review.
• Eliminate manual updates as all data is automatically updated from CAPTIS® literature review module.