IDBS PIMS And Regulatory Compliance

Meeting FDA 21 CFR Part 11 requirements demands specific system capabilities: validated operations, accurate record generation, robust protection, limited access, and detailed audit trails. IDBS PIMS delivers these through a suite of integrated features designed for compliance. Key functionalities include configurable session timeouts, login attempt limits, mandatory approvals, and secure electronic signature processes (Submit, Approve, Reject) directly linked to records.

Furthermore, PIMS boasts a comprehensive audit trail logging the user, action, object, timestamp, and value changes, directly supporting section 11.10(e). This datasheet provides a detailed breakdown, mapping specific PIMS features to relevant 21 CFR Part 11 sections, demonstrating its capability to support your compliance framework. Explore the compliance-enabling features within IDBS PIMS – download the datasheet for a detailed overview.