Octet® BLI 21 CFR Part 11 Compliance Checklist
A comprehensive tool set for compliance makes the Octet® BLI platform an ideal analytical instrument in regulated quality control (QC) labs for lot release and in-process testing for ligand binding, concentration, and impurity analysis in both upstream and downstream processes.
Overview
The document is a comprehensive checklist designed to ensure compliance with FDA 21 CFR Part 11 for the Octet® Bio-Layer Interferometry (BLI) system. It covers the necessary controls and procedures for maintaining a secure system capable of handling electronic records and electronic signatures. The checklist guides users through validating system access, audit trails, and electronic signatures to meet regulatory standards.
Overall, it provides a detailed framework for users of the Octet® BLI platform to comply with FDA 21 CFR Part 11, ensuring the integrity and security of electronic records and signatures in their operations.
Document type: eBook
Page count: 17
Read time: 30 minutes
Last updated: February 28, 2024
Key areas include:
- System access controls to prevent unauthorized use
- Validation processes to confirm system reliability
- Secure audit trails reflecting electronic record changes
- Electronic signatures that are unique to each user and legally binding
- Procedures for compromised identification
- Measures to prevent repudiation of electronic signatures
Your Questions Answered
The Octet® 21 CFR Part 11 Software package includes all features available in the regular Octet® BLI Discovery and Octet® Analysis Studio software package but Octet® 21 CFR Part 11 Software has features to allow users to produce electronic records that meet the requirements of the FDA 21 CFR Part 11 Final Rule. This includes features such as administratively controlled application access, user group with defined access and roles, an audit trail, and electronic signatures of artifacts.
All Octet® R-Series BLI systems can use the Octet® 21 CFR Part 11 software package with basic Installation Qualification and Operational Qualification (IQ/OQ) and Performance Qualification (PQ). However, the Octet® R8 and Octet® RH16 (beginning SN 20325+) systems are better suited for a GxP environment due to the availability of extended IQ/OQ, and PQ packages that add more tests and documentation to verify the functioning of the systems and QC assay kits that generate automatic reports in the Octet® Analysis Studio Software.
Yes, Octet® CFR Software versions 10 and above are compatible with Windows 10 32-bit and 64-bit beginning with Windows 10 version 1607, the “Anniversary Update.” Windows 10 versions 1507 and 1511 are not supported. We recommend Windows 10 64-bit Professional or Enterprise. Windows 7 is no longer supported. Octet® Software version 13 is also compatible with Windows 11.
For Octet® BLI Discovery Software when recording data, the files should be stored to the local computer and after recording, the files can then be moved to a network drive for backup. The Octet® Analysis Studio Software can be installed on a server or workstation and then users can remote desktop to it.
There are no enforced limits. The practical limit is the space available on the computer hard drive.
Audit trails are recorded in the database managed by the Octet® GxP server software. Each experiment has a unique identifier, and all data-specific audit trails are logged with the experiment identifier.