Validation Using a Text Editor

Validation Using a Text Editor (e.g., Microsoft Word) is One of The Biggest Bottlenecks in The Regulated Industry

- Word processing

- Generating risks, requirements, and tests from scratch

- Printing, filling out paper copy, and scanning

- Formatting evidence and cancelling fields

- Evidence formatting and field cancellation

- Physical signing & scanning

- Remote and Electronic Approval

While incorporating systems to streamline document review and approval processes, validation documents based on text editor requires manual activities, such as managing activities, creating documents from scratch, formatting, scanning, etc. All cost time and money and do not differ significantly between these two models.


By using a fully developed system for this purpose, such as GO!FIVE®, a cloud-based validation system with a knowledge database (library), it is possible to perform validations and qualifications 5x faster.  

- Risk management

- Requirements management

- Test management

- Automatic traceability matrix

- Incident management

- Inventory management

- Verification and Validation - V&V

- Data Integrity

- Access Control

- FDA 21 CFR Part 11 Compliance

I hope you found this article helpful! To learn more, click here to access the article entitled "Digital Manual Validation and the Risk to Data Integrity", in which you can download a complete e-book that addresses some of the risks associated with digital manual validation and data integrity.

*Microsoft Word is a trademark of the Microsoft group of companies.