Enforced Requirements

• FDA intends to enforce the following requirements for its compliance

• Validation
• The software system is validated for its accuracy, reliability, integrity, availability, and authenticity of required records and signatures
• Audit Trail
• Audit trails can be particularly appropriate when users are expected to create, modify, or delete regulated records during normal operation
• Copies of Records and Data Retention
• In each case, FDA recommend that the copying process used produces copies that preserve the content and meaning of the record