Overview of stability software

This software is designed as per the guidelines of US FDA 21 CFR PART 11 and is built upon the fast scanning core to view online status with minimum delay. The communication scanning core is optimized with the new Stability Control System software architecture. Some of its features are as follows:

1. Password Protection: Alphanumeric password with automatic password expiry. Separate password for individual users.
2. Auto Data Downloading: Auto Data Downloading can be launched in the background without slowing down the computer performance.
3. Secure User Login: Secure user login with 100% traceability in audit trail.
4. Remote Software Control: All the parameters are settable through software such as alarm limits, set points, start/sop function etc...
5. Real Time Trend: Real time trend of individual chamber with process value and trends for all the sensors online and offline.
6. Role Master & User Master: Role maser to create user access level and User Master to create new login ID’s in software.
7. Inputs and Output status: All the control inputs and outputs status visible like door open, standby system working etc.
8. Reports: Reports available such as Main controlling sensor (Chamber) report, Data logger (scanner) report, Events Alarms Reports, Audit Trail Report (Chamber wise & User wise), Door Access Report, Email Report, GSM Report, Chamber Graph Report, Data logger Graph Report, etc.
9. Auto Backup & Manual Backup utility: User can select backup type for automatic backup or manual backup. Facility to define path in the software to store this backup to the connected server.
10. Backup Restore Utility: To view/analyze backup data facility available to restore the backup file.
11. Door Access Setup: Can get the details of which user opened the door with door opening & door closing event with facility to put e-comments.
12. Event Alarm Logging: All the safety cutoffs and alarms, SMS from mobile alerts, events (changeover of standby system) is logged in the software with facility to put e-comments.
13. Electronic Signature: Submission, Review and Approval of all reports electronically thus making report generation paperless & eliminating the activity of taking printouts.
14. E-Remarks with Password: Password protection of every activity in software with mandatory E-Remarks (reason for change) available in the software.
15. E-Mail & SMS: Facility to configure and send E-Mail & SMS for event to 10 different E-Mail ID’s & Phone Numbers.
16. Password Aging: Configurable password aging parameter with facility to give intimation password expiry popup before 7 days.
17. Client Server Connectivity: Software can be accessed over two PC’s in the same LAN network without software installation.
18. Account Lockout: Mechanism to lockout the user account for more than 3 failed login attempts thus automatically limiting the failed login attempts.
19. Data Archiving: Facility to archive the data from the database only after ensuring that it is being backed up.
20. Auto Logoff: Automatically password protects the software if left idle for short period (5 minutes)

For more information about stability software (21CFR part 11), contact Thermolab Scientific Equipments.

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