Designed to meet the requirements of the FDA Regulation 21 CFR Part 11 for Electronic Records and Signatures, this software provides additional security such as password ageing, electronic signatures and time stamped audit trail.A secure, product-generated, time-stamped audit trail to record the date and time,operator details and actions taken on the recorder. The Audit Trail is kept with the electronic process data, records all actions and cannot be separated from the process data, removed or modified.
Auditor features allow for signing of all actions - operators will need to re-enter user name and password before an action is complete. Recorder can also be made to request authorisation - a second signature - before the action is completed. An authorised operator is able to add comments to the data record by entering their correct user name and password followed by the required text. The full comment complete with the operator name, date and time is recorded in the data file to become an integral part of the data record.
The Pilot XT-DL (Data Logging) version stores all instrument readings.
Data stored in binary encrypted
Check-summed format Integral Audit Trail Special user access permission
Configurable for each user
Unlimited user accounts Password controlled
Comprehensive Electronics Records and Electronic Signatures meeting 21 CFR Part 11
Once transferred the data can be used to recreate the charts, and spreadsheets for viewing and if necessary printing. It is a powerful tool for analysis and display and provides an easy way to review stored data by point or time. It also provides the user with a simple connection to the instrument from anywhere that has access to the network. From this remote connection the user has the potential to carry out any operation that they could on the instrument itself. The remote viewing connection has the same look and feel of the instrument display but is independent - i.e. if the user scrolls between screens on the remote PC this will not change the local operator view.