Home Page

This site contains detailed templates for documenting web applications to meet US FDA and European Union EMA regulations so that you don’t have to start from a “blank slate” for each new project.

The templates are based on GAMP5 best practices and the ISO 27001 security standard and can be downloaded and converted to pdf and docx formats. Templates include procedures for setting up quality and information management systems and testing web applications and infrastructure.

For more information on:

• The regulations and standards, see Overview of Regulations.

• Getting started using the templates, see Quick Start.

• Examples and templates that you can download, see List of Examples

• How this site is built, see About the Site