21 CFR Part 11 functionality
21 CFR Part 11 is a US Federal Standard specifying requirements for electronic records and signatures. In the EffiValidation software, the following tools are implemented to cover these requirements:
- Access controls
- Automatically generated global audit trials and the history of electronic records
- Unique secure electronic signatures
- Ability to disclose deleted records, i.e. the bin
Global audit trial and history consistently records the user name, computer name, and the date and time of entering and editing data and performing software operations. All data entered and saved in the software is stored in a database. Data handling is recorded in history, without any option of changing, re-writing or concealing previous information. In addition, data deleted using the delete function is kept in a recycle bin from which they can be displayed or restored.
The history window can be accessed from anywhere in the software (in the list
of methods window, data table window, electronic record books, etc.), opened by
clicking the history button. The appearance of the opened history window is the
same as at the given date and time.
