Requirements of 21 CFR Part 11 The FDA mandates that businesses maintain documents electronically. Organizations operating a closed system must comply with the requirements outlined in 21 CFR Part 11.10. This includes implementing procedures and controls that protect the authenticity, integrity, and confidentiality of electronic records. Key requirements include: 1. Validating systems to ensure data security and record integrity 2. Maintaining a complete audit trail to document the progression of processes 3. Restricting system access to enhance security 4. Providing essential training for all system users to perform daily tasks effectively 5. Enabling record generation with search and indexing capabilities for efficient retrieval 6. Establishing quality procedures to ensure operational control over personnel and processes throughout the development lifecycle 7. Implementing digital signatures across the organization to streamline and expedite the approval process For more Information, Please Visit: https://www.compliancequest.com/21-cfr-part-11-compliance/