Clarify and standardize the process, responsibilities, and documentation required to update Standard Operating Procedures (SOPs) for the Pharma Devils program/organization, ensuring regulatory compliance, traceability, and controlled implementation.
The SOP update was approved by "The System Admin" or a generic user account like "QA_Service," not a named, qualified individual. This is a massive 21 CFR Part 11 violation regarding electronic signatures. pharma devils sop upd