21 CFR Compliance for laboratory instruments
- Use of validated existing and new computerized systems.
- Secure retention of electronic records and instant retrieval.
- User-independent computer generated time-stamped audit trails.
- System and data security, data integrity and confidentiality through limited authorized access to systems and records.
- Use of secure electronic signatures for closed and open systems
- .Use of digital signatures for open systems.
- Use of operational checks.
- Use of device checks.
- Determination that the persons who develop, maintain or use electronic systems have the education, training and experience to perform their assigned task.