GMP Document Control Management
Manufacturing companies perform functions that are usually written down either manually or electronically. FDA regulations require companies to manage documentation such as Standard Operating Procedures (SOPs), Design History Files (DHF), Batch Records, and employee training records. Many companies are now relying on document control software to ensure product quality and safety.
FDA regulations require GMP document control measures to ensure the integrity of SOPs, documents in the Design History File (DHF), batch records, employee training records, and similar documentation. The lack of GMP document control accounts for the majority of FDA Form 483s. MasterControl's GMP document control software provides companies with the ability to manage GMP documentation efficiently and effectively while maintaining compliance.