MILESTONE
USER MANUAL
Ethos EZ User manual MA073-006
- 86 -
APPENDIX 1
DECLARATION OF COMPLIANCE"EASYCONTROL SOFTWARE"
WITH FDA-21CFRPART11
The Microwave system with controller and easycontrol software fulfils the requirements of a
„closed“ system.
21 CFR Part
11
Requirement easycontrol software solution
Chapter B Data records in electronic form
11.10 Controls for „closed“ Systems
11.10 (a) Validation of systems The organization of the user must accomplish a
validation of the easycontrol software. On request
"Milestone" can provide detailed documentation
on the software development, test, update,
administration and filing
11.10 (a) Ability to discern invalid
or altered data records.
The easycontrol software controls the correctness
of the data on the basis of check sums. Altered
records cannot be opened nor used.
11.10 (b) Ability to generate
accurate and complete
copies of data records
All data records can be viewed, copied and
printed with the easycontrol software.
11.10 (c) Protection of records to
enable their accurate and
ready retrieval
The data records can always be viewed and
printed, with the same version that was used for
their recording.
Additionally they can be exported with the PC-
Software "easyDOC" in any standard Windows
Text-Format. These files can be viewed with any
standard text editor software.
11.10 (d) Limited system access to
authorized persons
The microwave system with controller and
easycontrol software fulfills the requirements of a
"closed System". The access to the system is
divided in 3 levels
- Supervisor + Service
- Administrator
- User
The access to the appropriate level is possible
only by the identification using a write-protected
memory card and an additional password.
Every access level has different rights on the
system and control parameters which cannot be
modified.
11.10 (e) Complete and secure A Process Report (History trail) records all
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