21 CFR Part 11 Compliance

• Electronic audit trail function automatically generated for all operator entries
• audit trail completely outside the control and access of users (except for read-only access of the audit trail file)
• Impossible to disable audit trail function
• System date and time protected from unauthorized change
• Data changed or deleted, all previous values still electronically available
• Procedure for reissuing forgotten passwords
• Signature made up of at least two distinct identification components, such as an identification code and password
• Records created for all GMP-relevant changes and deletions (a system generated “audit trail”)
• Change or deletion of GMP –relevant data there is a provision for mentioning the reason
• Expiry of password and forcing the employee to change
• Dual Authentication
• Full Transaction Log
• Routing Mechanism & Authorisation
• Transaction Log methodology
• Fully complaint with latest security standard
• Secured enough to be deployed in defense like environment
• System will be immune to network hacking and cracking
• 100% Network log