Milestone ultraWAVE 3 - Appendix 2 - Declaration of Compliance Easycontrol Software with Fda-21 Cfrpart11

Milestone Srl MA245-001 – ultraWAVE 3 – User Manual
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16 APPENDIX 2 - DECLARATION OF
COMPLIANCE "EASYCONTROL SOFTWARE"
WITH FDA-21CFRPART11
The below table reports: the reference code of the regulation, the description of the regulation and how
Milestone instruments with T660 terminal comply or, when this is requested, how it supports the
organization of the user to fulfilling to.
Ref. #
Description
T660 easyCONTROL software solution
(rev. 02-D and following)
11.10
Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ
procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the
confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed
record as not genuine. Such procedures and controls shall include the following:
11.10 (a)
Validation of systems to ensure
accuracy, reliability, consistent
intended performance, and the
ability to discern invalid or altered
records.
The organization of the user must accomplish a validation
of the easyCONTROL software.
Validation documents such as (VP), IQ, OQ, PQ, DQ, FAT
protocols are available.
The easyCONTROL software controls the correctness of
the data on the basis of check sums. Invalid records
cannot be opened nor used. Executed cycles are not open
files and cannot be altered while any other modification of
electronic records is registered and fully traceable in the
Trail section.
11.10 (b)
The ability to generate accurate and
complete copies of records in both
human readable and electronic form
suitable for inspection, review, and
copying by the agency. Persons
should contact the agency if there
are any questions regarding the
ability of the agency to perform
such review and copying of the
electronic records.
Records generated by easyCONTROL software are
automatically saved on the memory support (terminal,
USB stick or LAN network folder) according to the type of
data and to the software configuration.
All data records can be viewed, copied and printed with
the easyCONTROL software and then exported on
standard file formats like .pdf, bitmap, .csv, xls.
11.10 (c)
Protection of records to enable their
accurate and ready retrieval
throughout the records retention
The data records can always be viewed and printed, with
the same software version that was used for their
recording.
Additionally, records can be exported as standard file
formats like .pdf, bitmap, .xls, .csv.
Automatic records saving features are available on
easyCONTROL software.