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21 CFR Compliance
for laboratory instruments
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Requirements of Part 11 (electronic records;
electronic signatures) are:
- 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.
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