21 CFR Part 11 in Clarity

This section describes how Clarity supports compliance with CFR 21 Part 11 requirements.

The detailed 21 CFR Part 11 requirements for Clarity can be found in the D019 Clarity 21 CFR Part 11 tools datasheet. For the most of the requirements set by the 21 CFR Part 11, the necessary conditions must first be defined at the company level.

However, the following articles of 21 CFR Part 11 are supported by Clarity (some fully, some only partially) and the corresponding setup procedures are described in this help.

Mandatory

• § 11.10 a, § 11.10 i - Clarity software must be validated. This is accomplished by the DataApex Quality Assurance system (see the D028 ISO9001:2015 certificate datasheet) and verified and verified by Installation Qualification (IQ) and Operational Qualification (OQ).
• IQ verifies that the Clarity software is correctly installed and that all required components are present in the correct versions. The results of IQ are documented in IQ report.
• OQ verifies that the installed Clarity system operates in accordance with manufacturer’s specifications. DataApex considers the OQ to be valid only if it is performed by a person authorized by DataApex. Authorization is granted by a certificate issued by DataApex.
• § 11.10 c - You must ensure that the data are stored and can be retrieved throughout the entire record retention period - see the chapter "Archiving the data".
• § 11.10 d, § 11.10 g - System access must be limited to authorized individuals - see the chapter "Computer User Rights" and the chapter "User Accounts in Clarity".
• § 11.10 e - Every action performed in the Clarity system must be recorded in a secure Audit Trail - see the chapter "Logging of all changes".
• § 11.50, §11.70, § 11.100 - It must be possible to sign electronic data in the Clarity using electronic signatures that are unique to each individual, are not reused or reassigned, and cannot be manipulated - see the chapter "Electronic signatures"the chapter "Logging of all changes".
• § 11.200 a - Any access or signature must be performed based on two distinct identification components - see the chapter "Clarity GLP Options" and the chapter "Electronic signatures"the chapter "Logging of all changes".
• § 11.300 - Each security code / password pair must be unique to a single user. Moreover, each password must be periodically verified and updated - see the chapter "User Accounts in Clarity".