21 CFR Part 11 has two main areas of enforcement: electronic records and electronic signatures. Moving to a paperless world with fully electronic data handling promises cost savings from improved efficiency and reduced physical handling and storage. Electronic signatures are given legal equivalence with traditional "wet ink" signatures on paper. In Life Sciences companies, 21 CFR Part 11 is applied to automation or computer system applications that manage product-related data such as:
- Calibration and maintenance
- Cleaning automation
- Corrective actions
- Critical equipment and instrumentation
- Facility and building automation
- HVAC controls and alarm handling
- Manufacturing instructions
- Material traceability
- Recipes and formulations
- Packaging automation and labeling information
- Security access control
The Industrial IT Extended Automation System 800xA facilitates compliance with the rule with features like system security, secure data management and reporting, electronic records and signatures, and the automated electronic recording of changes. Core system functions that support regulatory requirements are:
- Access control
- Authentication and re-authentication
- Alarm and event management
- Audit trail
- Batch control and management
- Electronic recording
- Electronic signatures
- Event reports
- History and archiving
- Trends
- Redundancy
- Sequential function charts
- Shift, production and batch reports
- Infrastructure and network security
System 800xA makes automation and regulatory compliance easy.