Advanced CFR 21 Part 11 Solution

Optionally available for the new Systec HX series.

Since 1997, the "FDA CFR 21 Part 11" regulations of the US Food and Drug Administration (FDA) have formed the international industry-wide standard for the digital documentation of processes in medical technology, production and pharmaceuticals. The criteria defined in CFR 21 Part 11 ensure greater efficiency through automated, paperless and tamper-proof digital processing of process flow and audit trail data. With the "Advanced CFR 21 Part 11 Solution" option, Systec autoclaves in the HX series support documentation in accordance with FDA CFR Part 11 - without additional software and/or hardware.

CFR 21 Part 11 solution

Tamper-proof and paperless documentation in accordance with GMP

With the Advanced CFR 21 Part 11 solution for the Systec HX series, process data can be read out and saved in detail. The Advanced CFR 21 Part 11 solution from Systec also offers

• Readout of data as PDF or CSV files digitally signed electronically by the autoclave in accordance with the X.509 standard via USB connection or network interface (automatic readout to FTP, SFTP and FTPS server only with "Save to Folder" option).
• Security function for automatic invalidation of data if tampering attempts are detected.
• Extensively expanded user account control for up to 100 customizable groups and 100 users.
• AuditTrail for reading out the chronological documentation of detailed, unalterably stored system and process activities.

All information read out (PDF and CSV files, AuditTrail logs) is CFR Part 11 compliant. Unchangeable and tamper-proof. The data can be clearly assigned to the respective autoclave, as it is electronically signed by the autoclave and immediately marked as invalid in the event of tampering attempts. This allows the correct handling of the autoclave to be proven to supervisory authorities, for example.

Comprehensive solution - no additional software required

When reading out process data from conventional autoclaves, several devices are typically used, as a separate PC with corresponding software is required. This approach generates additional costs as the PC has to be validated. Furthermore, automatic updates (e.g. operating system updates) may lead to incompatibilities with the documentation software used.

With the Systec HX series with Advanced CFR 21 Part 11 solution, this is ruled out as the necessary software package is already pre-installed and runs independently of external hardware. External PCs or storage media are therefore only required to read out the data as signed PDF or CSV files. AuditTrail information can also be shown on the autoclave's integrated touch display and read out to a USB storage medium via USB.

Safe, validatable and efficient

The Advanced CFR 21 Part 11 solution for Systec HX series autoclaves optimizes the digital documentation process based on the FDA CFR Part 11 regulations, saving hardware and software costs while ensuring absolute compliance with international standards. The hardware and software components of the autoclaves can also be adapted to the requirements of different industries with additional options.

You can also find a brief overview of the Advanced CFR 21 Part 11 solution here.

Please contact us if you have any questions about Systec HX series autoclaves and the perfect customization options for you.