IDIS EE Universal Dissolution Automated Software
Open Platform 21 CFR Part 11 Tablet Dissolution Data Management Software
FDA 21 CFR Part 11 Compliance

11.10 (d) Limiting access to unauthorised individuals
Configurable Centralised Security

11.300 No two individuals have the same name and password.
11.300 (d) Thansaction safeguards to prevent unauthorised attempts to access system.
11.10 (e) Computer generated  time stamped audit trail.
User Queryable Audit Trail

IDIS EE Audit Trail lists all user activity that creates, deletes or modifies; i.e., from logging on and off to editing of method and data records.
Signing and Reporting Signed Records

Once data is acquired in a group with signing rights, any report generated will show the signing status for all records as shown below.