Comark EV SOFTWARE - Manual (Page 19)

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11.0 Mean Kinetic Temperature/Lethality/Pasteurisation
(EV Pro Only)
It is possible via the task set up to enter values for:
Mean Kinetic Temperature
Lethality
Pasteurisation
Please refer to the user guide within the software for more information on the calculations for
MKT/Lethality and Pasteurisation.
12.0 21 Title CFR Part 11
12.1 What is 21 CFR Part 11?
The FDA (Food and Drug Administration) in the USA, issued regulations Title 21 CFR
(Code of Federal Regulations) Part 11 that provide criteria for acceptance by FDA or an
approved regulatory body, for the acceptance of electronic records, electronic signatures,
and handwritten signatures executed to electronic records as equivalent to paper
records and handwritten signatures executed on paper. These regulations, which apply
to all FDA program areas, are intended to permit the widest possible use of electronic
technology, compatible with the FDA’s responsibility to promote and protect public health.
Part 11 applies to any record governed by an existing FDA predicate rule that is created,
modified, maintained, archived, retrieved, or transmitted using computers and/or saved
on durable storage media. In other words any record from a data logger, for instance that
is at some stage stored on a PC or where a PC is used to retrieve the data, 21 CFR Part
11 can be applied.
12.2 Title 21 CFR Definitions
Electronic Record - Any combination of text, graphics, data, audio, pictorial or other
information representation in digital form, that is created, modified, maintained, archived,
retrieved or distributed by a computer system.
Electronic Signature - A computer data compilation of any symbol or series of symbols,
executed, adopted or authorised by an individual to be legally binding equivalent of the
individual’s handwritten signature.
Digital Signature - An electronic signature based upon cryptographic methods or
originator authentication, computed by using a set of rules and a set of parameters such
that the identity of the signer and the integrity of the data can be verified.
Closed System - An environment in which system access is controlled by persons who
are responsible for the content of electronic records that are on the system.
Open System – An environment in which system access is not controlled by persons
who are responsible for the content of electronic records that are on the system.