CC Software LLC (dba Confident LIMS)

Last Updated Date: 2025-09-22

Introduction

Confident LIMS is a Laboratory Information Management System developed by CC Software LLC (“Confident”) for use in regulated laboratory environments. This document provides a self-attestation by Confident of Confident’s compliance with the FDA 21 CFR Part 11 (Electronic Records; Electronic Signatures) framework.

This attestation reflects our internal evaluation of the operating effectiveness of controls related to security, availability, confidentiality, processing integrity, and privacy, over the period 2025-01-01 to the Last Updated Date above.

Compliance Statement

From 2025-01-01 to the Last Updated Date above, Confident affirms that its controls were designed, implemented, and operated in alignment with 21 CFR Part 11 requirements as outlined herein. No third-party audit or certification has been performed; however, we have found no known gaps in our compliance with Part 11 requirements. The FDA does not currently offer an official certification for Part 11 compliance. This attestation is provided in good faith based on internal analysis.

Signed:

Stephen Albarran

Chief Executive Officer

CC Software LLC (dba Confident LIMS)

System Validation and Integrity

• Software Validation: Confident LIMS is developed and tested following documented procedures to ensure it is suitable for its intended use (per 21 CFR 11.10(a)). We perform quality assurance testing and validation on updates to confirm that the system reliably meets its specifications and maintains data integrity.
• Change Control: We have change management processes in place so that any updates to the system are reviewed and tested to prevent adverse impact on record integrity. All modifications are logged and version-controlled.

User Access and Authorization

• Closed System Controls: Confident LIMS operates as a closed system, meaning only authorized individuals with issued credentials can access it. The system is designed to ensure only permitted users can log in and perform specific actions through role-based permissions.