21 CFR Part 11 - requirements

The commented 21 CFR Part 11 requirements for Clarity may be found in the D019-Clarity-21CFR11.pdf datasheet available on the DataApex website. For the majority of requirements set by the 21 CFR Part 11 regulation the conditions must first be set at the company level. However, the following list of articles belonging to the 21 CFR Part 11 regulation is supplied by Clarity (some fully, some only in part) and necessary setup is fully 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-DataApex-cert.pdf datasheet available on the DataApex website, and the verification that the software was successfully installed provided by the IQ report, see the chapter "Installing Clarity".
• § 11.10 c - You must ensure that the data is stored and can be retrieved during the whole records 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 - Any action performed in the Clarity system must be recorded in 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 with electronic signatures that are unique to each individual, will not be reused by, or reassigned to, anyone else 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 settings" and the chapter "Electronic signatures"the chapter "Logging of all changes".
• § 11.300 - Any security code / password pair must be unique to a single user. Moreover, each password must be periodically checked and revised - see the chapter "User Accounts in Clarity".