Data Logging Software with 21 CFR Part 11 Features
- Database on SQL.
- LAN Connectivity.
- Security policy password length, unique id and password composition.
- Password validity/expiry. Change of password for the first login.
- Wrong password attempts limit.
- System logs off if kept idle.
User management system and privileges
- User level based on functionality and authority user details.
- User master priviliges like delete, copy, cut, paste, rename not allowed to unauthorised users.
- Multiple user creation.
- Electronic data is human readable and suitable for inspection for review.
- Contents like print-by-date-and-time, reviewed by with-date-and-time analysis and system parameter information.
- Equipment master window, displaying all the equipment’s with name and equipment status.
- Real time summary along with current status of the equipment.
- Multiple chamber connectivity.
- Real time and historical trend for analysis.
Electronic Data Storage
- Alarms: Report alarm/event with print option and filter authorised user access.
- Data log
- Backup manual and Auto backup with pre-defined path restore.
- Report data log with print option and filter.
- Report MKT with print option and filter
- Data logging are predefined interval.
- Printing option PDF
- Report audit trail with print option and filter.
- User audit trail with filter.
- Critical hardware related errors and warning logged.
- Time and date stamp change automatically. It is locked and cannot be edited apart from an authorised user.
- Reason for any relevant change is recorded along with the user who made the change.
- Deletion and modification is not allowed.
- Comments for alarm occurence.
- Automatic Electronic signature generation.
- Name of the authority along with the date and time.
- Responsibilities such as review, approval associated.
- Email and SMS configuration.
- Windows-compatible computer with a standard keyborad, a pointer input (i.e. a mouse, trackpad, or touchscreen)
- ‘Microsoft SQL 2012 free version’ to be provided by customer.
- Windows 7 or above. RAM 8GB, hard disk 500 GB.
- Microsoft Office 7 or higher (Professional is recommended).
- Processor: Intel 13 or higher. Com port for communication.
- Acrobat Reader (to view PDF files). Ethernet/LAN Connectivity.
- Required ‘D’ drive for data back-up.