Data Logging Software with 21 CFR Part 11 Features


  • Database on SQL.
  • Ethernet
  • LAN Connectivity.

Licence software

Password Policy

  • 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

  • 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

  • Trends
  • 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

Audit Trail

  • 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.

Electronic Signature

  • Automatic Electronic signature generation.
  • Name of the authority along with the date and time.
  • Responsibilities such as review, approval associated.
  • Email and SMS configuration.

Computer Configuration
PC/Laptop requirement

  • 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.