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Fabrication Nº:
Equipment:
OPERATING INSTRUCTIONS AND MAINTENANCE MANUAL
9.7.4
Actions register
All operations considered as critical (those that can affect the final product) are
recorded in the SD memory card located on control screen, 'Audit Trail 0' file.
Depending on the critically level of the action, prior to its execution, it is required
the user to enter its electronic signature (password) and a brief comment detailing
the reason for the order (see listings attached below).
Actions recorded without electronic signature requirements
Log-in/Log off user
Change of Process MODE / Recipe MODE
Start/Stop Process
Parameters configuration in Overview screen (Process MODE)
Start/Stop Recipe
Message confirmation
Reset alarms
Silence alarms
Weight calibration. Known weight
Weight calibration. Tare Mode
Weight calibration. Reset Mode.
Actions recorded with electronic signature requirements
Create/Save/Load new recipes
Users settings
Change date and hour
Load Factory default values
Parameters configuration:
Parameters in SERVICE screen
-
Parameters in PID screen
-
Reduction parameter in VF ABB screen
-
Temperature parameters (Min, Max, CAL) in CALIBRATION screen
-
Audit Trail files are important documents, so it is necessary to perform a
periodically backup, by saving the files on an external PC.
it is responsibility of the end customer to have the corresponding SOP's
(Standard Operational Procedures) to ensure the proper use of the
system (making backups, users trainings,...) and the procedure for users
managing (how to proceed in case of theft or loss of password,...)
Ref. ProJect / Revision:
721021-07 / R01
721021-70-1 / 721021-70-3
VESSEL FOR CREAMS – Mod. VCR 1002 / MELT TANK – Mod. MET 0400
Client:
UNIPHARMA
Date:
11-2015
EN
ES
MDI VCR (v1.0)
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