Systec® Advanced 21 CFR Part 11 Solution

Advanced 21 CFR Part 11 solution for model series: HX All data can be downloaded from the autoclave via USB as PDF and/or CSV (Excel) files. Both the PDF and CSV files are electronically signed by the autoclave. This electronic signature can be assigned to the respective autoclave without any doubt. At the same time, it indicates whether the exported files are valid (i.e., valid). Any attempt at manipulation directly results in the respective file being marked as invalid. The Advanced CFR 21 Part 11 solution also includes: - Advanced user account control. This includes, among other things, an individual or global program list per user, the assignment of the user to a customizable group (e.g. user, supervisor, administrator, cleaner, etc.) with customizable rights. - AuditTrail: All actions performed (e.g., changing parameters, starting or stopping sterilization programs) are documented and can be traced back to the respective user as well as via a timestamp (date/time). - Up to 5 fields for electronic signatures to sign the exported PDF or CSV files on a PC (or other device with the functionality to sign documents electronically). The electronic signatures are not included in this option.