App Note: Achieving 21 CFR Part 11 Compliance with the iCE3

Rapid analysis, platform methods and easy method development make the iCE3 ideal for analyzing biologics…

Rapid analysis, platform methods and easy method development make the iCE3 ideal for analysing biologics. In fact, these benefits have made iCE™ cIEF assays one of the key assays for biologics characterization and release today. As electronic data authenticity and integrity are now an integral part of GMP manufacturing for pharmaceutical companies, all analytical instruments must be compliant with the FDA Title 21 Code of Federal Regulations (CFR) Part 11.

This guidance defines the requirements for GMP compliant electronic records and signatures including procedural controls such as training and standard operating procedures as well as software technical controls to maintain data security. To support the use of iCE3 in QC and GMP environments, all required functionality is integrated in iCE CFR software to ensure compliance with 21 CFR Part 11. iCE CFR software includes the following 21 CFR Part 11 technical controls:

• User defined login function to limit system access
• Electronic signatures are required throughout run execution, processing and exporting
• A secure, computer-generated, time-stamped audit trail records the date and time of all operator entries and actions that create or modify electronic records
• Accurate and complete copies of records in both printed and electronic format
• Operational system and network domain features that ensure data authenticity and integrity are maintained
• File string encryption and industry standard checksum algorithm application for verification of data integrity

Operational restrictions limit inadvertent or unauthorized changes to strengthen GMP compliant batch execution In this application note we will review the iCE3 data workflow and the 21 CFR Part 11 tools in iCE CFR software, with a specific focus on the embedded controls in the batch execution, data processing, audit trail and electronic signatures functions.