Software Manual Freedom EVOware Standard 2.3 Freedom ...

B - Appendix B - FDA 21 CFR Part 11 Compliance
Part A - General Provisions
B.6.1.1 § 11.1(a) Criteria
Compliance Freedom EVOware
The features implemented in Freedom EVOware that deal with electronic
records and electronic signatures are described in detail in the following
sections and in B.5.5 “Electronic Signatures”, B-9.
Compliance Tecan Customer
Tecan customers must develop a procedure to establish criteria under which
electronic records, electronic signatures and handwritten signatures executed
on electronic records are considered to be trustworthy, reliable and generally
equivalent to paper records and handwritten signatures.
B.6.1.2 § 11.1(b) Records In Electronic Form
Compliance Freedom EVOware
Freedom EVOware uses specified directories to store process data, the trace
file (audit trail) and the log files. A default directory structure is created for
these files when Freedom EVOware is first installed. See A.5 “Freedom
EVOware Directory Structure and Files”, A-25 for a list of the files and
directories which are used. See also B.5.6 “Trace File (Audit Trail)”, B-10.
If required, users with Freedom EVOware Administrator or Application
Specialist rights can configure Freedom EVOware to use other directories
(including network directories) for storing data, log and output files. See
8.3.1.4 “Protocol Options Tab”, 8-8.
Compliance Tecan Customer
Tecan customers must develop a procedure to document which records in
electronic form are created, modified, maintained, archived, retrieved or
transmitted and where the records are stored on the computer system. This
does not apply to paper records that are transmitted by electronic means.
B.6.1.3 § 11.1(c) Electronic Signatures
Compliance Freedom EVOware
Freedom EVOware uses electronic signatures on data and configuration files.
See B.5.5 “Electronic Signatures”, B-9 for more information.
Compliance Tecan Customer
Tecan customers must develop a procedure to identify where electronic
signatures and their associated electronic records are equivalent to
handwritten signatures.
B.6.1.4 § 11.1(d) Electronic Records
Compliance Freedom EVOware
Freedom EVOware uses specified directories to store process data, the trace
file (audit trail) and the log files. A default directory structure is created for
these files when Freedom EVOware is first installed. See A.5 “Freedom
EVOware Directory Structure and Files”, A-25 for a list of the files and
directories which are used. See also B.5.6 “Trace File (Audit Trail)”, B-10.
If required, users with Freedom EVOware Administrator or Application
Specialist rights can configure Freedom EVOware to use other directories
(including network directories) for storing data, log and output files. See
8.3.1.4 “Protocol Options Tab”, 8-8.
B - 12 Freedom EVOware Software Manual, 393172, en, V2.3