FCS Express has a comprehensive security system that allows you to restrict access to various functions to particular users. This can be important for ensuring the integrity of your data analysis and to conform with certain government regulations such as 21 CFR Part 11. FCS Express offers multiple layers of security, described in the remaining sections of this page.
- Web Page - USA FDA CFR Title 21
- Web Page - Security
- User Manual - Security
- 21 CFR Compliance Matrix PDF
- Security and Logging Webinar
FCS Express has a comprehensive logging system that allows you to track every change made to any layout. Every time an action is performed in FCS Express, no matter what it is, this change is recorded. A brief description of the change is shown in the overview box at the top of the Layout History Viewer and a detailed description of the currently selected item is shown at the bottom.
System Level Audits allows users to track system level actions to an audit trail for further improving compliance with regulatory requirements such as 21 CFR Part 11.
FCS Express has a complete set of functionality to allow you to electronically sign your documents, a necessary features for CFR 21 Part 11 Compliance. FCS Express allows you to create as many signatures as you wish.
Users can be permitted to sign or unsign a layout. Additionally, tokens can be used to set conditions to electronically sign or unsign.
If you purchase FCS Express with the Security add-on, you have the choice of two database options:
- Microsoft SQL Server
- ElevateDB Local Server
- Web Page - System Requirements
- User Manual - Managing the Databases
- User Manual - Configuring MS SQL Server to host Security Databases
- User Manual - Backing Up the Database
- User Manual - Preparing for Database Updates