Darca Secure

Darca Secure software provides a tamperproof audit trail of events, secure data storage and managed data access.

Darca Secure is an enhancement to Darca Plus and has been designed in line with the requirements of FDA 21 CFR Part 11 recommendations as applicable to the Pharmaceuticals Industry, the relevant additional features are listed below. Darca Secure can only be used with GenII telemetry system receiver logger type 1000SC, refer to Eltek for details. Darca Secure cannot be used with 1000 series Squirrel loggers.

For details relating to FDA recommendations please refer to their Website: www.fda.gov/ora/compliance_ref/part11/frs/background/11cfr-fr.htm

Features

Enhanced name and password management
Darca Secure must be installed by the administrator. The first time it is run, the administrator will set up a password for each user. Passwords must contain at least 1 numeric character and be at least 8 characters long. The username of the administrator is always 'admin'.

User Management
A file option, User management enables the Administrator to add or delete users and change passwords for existing users.

Mandatory login screen
A login screen will appear whenever Darca is run. A valid username and password must be entered for the program to function. Users are automatically logged out when they close Darca.

Username and password protection
Password data is stored in encrypted form in order to protect passwords from unauthorised use.

Tamperproof Audit Trail
The Audit Trail keeps a log of all the main events that users perform and is only viewable by the administrator The following events are logged in the audit trail:

The Audit Trail file is encrypted on disk in order to make tampering impossible. It is backed up every time it is successfully opened, and an attempt is made to restore from this backup if the audit file is found to be corrupted. In the unlikely event that both files are damaged, the whole system will have to restored from a user-generated backup.

A print facility allows a hard copy of the Audit Trail to be generated.

Downloading data from a Squirrel

Memory integrity
A new checksum system has been introduced to ensure Squirrel's memory maintains physical integrity. On receipt of this checksum and the data, Darca will calculate its own version from the data and check the 2 values against each other. The data will be rejected if they do not match. Multi-run mode is disabled. Only 'Stop When Full' memory mode is available.

Creating the DAT file
Users must 'electronically sign' data by entering their username and password whenever they download data from the Squirrel. This is compared with the username and password of the currently logged in user. Once the necessary information and data is downloaded from Squirrel, it is written to a DAT file which is then encrypted on disk. When DAT files are opened for analysis they are re-encrypted on disk so as to be tamper resistant.

Linking the Audit Trail and DAT Files

An electronic 'fingerprint' of each DAT File is stored in the Audit Trail file along side the relevant 'Downloaded Squirrel' comment. This is not viewable by the users or administrator and serves to tie each DAT file to the system and prevent tampering on a single DAT file. For this reason, a new filename must always be specified when data is downloaded - users may not over-write old data with new data from the Squirrel.

As an added precaution Darca will not graph or export DAT files that are found to have been tampered with.

Mean Kinetic Temperature

A new section has been added to the Graph Summary window that allows you to enter the required constants and then view the mean kinetic temperature of each temperature channel.

Darca Secure, with respect to Darca Plus, cannot be used with Shed, the scheduling feature, or multiple runs, and is suitable only for use with telemetry based systems. Darca Secure is currently validated only for use with the Squirrel type 1000SC - telemetry logger.