Tuesday, 28 January 2014

21 CFR Compliance for laboratory instruments

21 CFR Compliance for laboratory instruments

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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