Software Manual Freedom EVOware Standard 2.3 Freedom ...

B - Appendix B - FDA 21 CFR Part 11 Compliance
Recommendations
Security mechanisms
This refers to techniques for ensuring that data stored in a computer cannot
be read or compromised. Most security measures involve encryption or
passwords.
Server
A computer or device on a network that manages network resources. A file
server stores files, a print server manages printers, a network server manages
network traffic and a database server processes database inquiries.
Service release or service pack
Defect-fix releases of an operating system that address serious issues or
defects reported against a previous release. Service releases need to be
installed on top of the original software. Service releases often address
security issues which have arisen during the use of the software. Generally
speaking, you should install the operating system service release specified for
the Freedom EVOware software to ensure maximum system security.
Shared desktop, account or login
Shared desktops, accounts or logins can violate the principle of no
repudiation. If the audit trail is not able to distinguish between individuals
using such shared network resources, an electronic signature is not valid.
Tecan customer
Company or organization which uses pipetting instruments and/or other
equipment which is manufactured by Tecan.
User name, User ID
A unique code used together with a password to identify a user.
Validation of a computer system
Confirmation by examination and provision of objective evidence that
computer system specifications conform to user needs and intended uses,
and that all requirements can be consistently fulfilled.
B.4 Recommendations
The following lists points to be considered to ensure compliance with 21 CFR Part
11.
Access security determines who is allowed to log in to a system locally or from a
network and puts mechanisms in place that prevent unauthorized persons from
gaining access to the computer system. For example, the Microsoft operating
systems Windows 2000, NT and XP provide several different types of access
privileges or rights that can be granted or denied to specific users or groups of
users.
System administrator: The person responsible for maintaining a multi-user
computer system and managing the security of the computer network.
Audit trails: 21 CFR Part 11 requires audit trails to be generated independently of
the equipment operator. They must record all activities related to creating,
modifying and deleting records on the system. The user organization must
develop procedures for the data integrity and long-term archiving of audit trails
with data retrieval throughout the legally required retention period.
Configuration settings: An overall organizational structure defining how
permissions or privileges are configured for the computer system, with settings
which may e.g. allow one user to only read a file while another person can
execute the file and a third person can write new data into it.
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