Sartorius Celsius S3 Mode D'emploi page 37

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5.6.11 21 CFR Part 11

Cryopilot 5 software has been designed to facilitate compliance with the

requirements of 21 CFR Part 11.

Digital signatures are used to prove that the authenticity and integrity of

Cryopilot 5 data files, even on open (i.e. untrusted) systems. The terms

"digital signature" and "electronic signature" should not be confused. A

digital signature is a cryptographic method, whereas an electronic signature

is an electronic equivalent of a handwritten signature with legal implications.

References to electronic signatures in 21 CFR Part 11 do not apply to the

digital signatures used in Cryopilot 5 data files.

Some general notes about implementation:

— Cryopilot 5 relies on the operating system for account management,

authentication, and authorization functions.

— The digital signature algorithm used by Cryopilot 5 is SHA-1 with RSA;

it is written in PKCS#7 format.

— The file system is treated as an untrusted system.

— When a process is stopped, the data file is closed and cannot be opened

again for modification. Any alteration of the data by other means,

whether accidental or malicious, will be detected by the digital signature

mechanism.

— Once data is exported from Cryopilot (e.g. to a spreadsheet), its

authenticity and integrity can no longer be ensured.

Operating Instructions Celsius

Cryopilot Software

Benchtop System

01.04.2022 09:52:17