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Since 1997, the FDA 21 CFR Part 11 regulations of the American Food and Drug Administration (FDA) have been the international industry-wide standard for the digital documentation of processes in medical technology, medical production and pharmaceuticals. The criteria defined in 21 CFR Part 11 ensure improved efficiency with the automated, paperless and tamper-proof digital recording of laboratory processes and audit trail data. With the Advanced 21 CFR Part 11 solution,  Systec’s HX series of autoclaves support documentation according to FDA CFR Part 11 – without any additional software or hardware.

TAMPER-PROOF AND PAPERLESS DOCUMENTATION IN ACCORDANCE WITH GMP

Process data can be exported and saved using the Advanced 21 CFR Part 11 solution of the new Systec HX series.  Systec’s Advanced 21 CFR Part 11 solution also provides:

• Exporting data as PDF or CSV files that are digitally signed by the autoclave according to the X.509 standard; exported via USB port or network interface (automatic export to FTP, SFTP and FTPS server only with “Save to Folder” option).
• Security function to automatically invalidate data if a manipulation attempt was detected.
• Advanced user account control for up to 100 customizable groups and 100 users.
• AuditTrail for the chronological documentation of detailed system and process activities. Audit trail data cannot be altered.