Part 11 Validation Services

21 CFR 11 (referred to as “Part 11”) addresses “records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations.”.    Part 11 requires the system that creates and prints/stores the electronic records must:

– Be “Validated” that they are installed, operating, and functioning as designed
– Limit system access to authorized individuals
– Allow FDA Access to records
– Provide for Electronic Record security & access
– Allow for Change Control and provide Audit Trails of any changes to records
– Electronic records & signatures must meet the same requirements as manually created records

First of all, FDA regulation 21 CFR 11 requires retort control systems that create and store electronic records must be “validated”. Validation is necessary to show compliance. Second, computer control systems that operate a retort utilize a system of sophisticated hardware and software routines. These systems are responsible for the safe delivery of a thermal process to the product. Validation is necessary for food safety. And finally, validation will identify how the system is designed the work, then physically challenge that the system is indeed performing as designed. Validation is simply good engineering practices. The better question is “why would you NOT validate your computer control system?”.

TechniCAL’s validation activities include the following three phases:

PHASE I: Development of Specifications
PHASE II: System Qualification & Part 11 Validation
PHASE III: Validation Documentation/Report

TechniCAL’s validation program, on-site activities, and deliverable documentation will comply with FDA regulations 21 CFR 11 regarding the use of electronic records and electronic signatures.  TechniCAL uses guidelines established in “NFPA BULLETIN 43-L – Validation Guidelines For Automated Control Of Food Processing Systems Used For The Processing And Packaging Of Preserved Foods”.