Advanced 21 CFR Part 11 Solution

Cookiename	Beispielinhalt	Ablaufzeit
_ga_*	deleted	730 Tage
_ga	GA1.1.8643343795.1726666186	730 Tage

Advanced 21 CFR Part 11 solution for model range: HX All data can be downloaded via USB as PDF and/or CSV (Excel) files from the autoclave. 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 leads directly to 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 programme list per user, the assignment of the user to an individually createable group (e.g. user, supervisor, administrator, cleaner, etc.) with individually adjustable rights. - AuditTrail: All actions performed (e.g. changing parameters, starting or stopping sterilisation programmes) 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 another device with the functionality to sign documents electronically). The electronic signatures are not included in this option. Advanced 21 CFR Part 11 with electronic signatures

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