NOVUS AUTOMATION
76/85
17.
CFR 21 REGULATION
17.1
SUPPORT FOR CFR 21 PART 11 AND RDC 17:2010 VALIDATION
LogBox Wi-Fi
can be part of a validated system by offering the following features for compliance support:
•
Device development follows the company’s quality standard. It has the ISO 9001 certification and follows good manufacturing practices, the
basis for compliance with GAMP 5 requirements in validation model V.
•
Device usage documentation will be available during the validation process, functional specification, and final acceptance testing.
•
The produced devices are identified by a serial number that allows tracking at the factory and that makes it possible to identify their calibration
report and other production information.
•
All data recorded in the device’s memory, whether of basic configuration, calibration, or involving the inputs readings, are protected against
improper tampering.
•
Access to the basic configuration and calibration parameters is done only by
NXperience
and with access credentials. These credentials are
unique and, for traceability purposes, should be associated with a person in charge.
•
The memory containing the basic configuration and calibration is protected by a mechanism that detects any improper changes. The
mechanism is composed of an electronic signature (
hash
). Any change in the parameters will be identified by a change in the electronic
signature, accessible for reading by the monitoring system.
•
Access to the data of the entries registered in the device’s memory is done only through
NXperience
and by access credentials. This data is
illegibly present in the memory and can be exported to readable formats while keeping the font unchanged.
•
The device allows only the modification of the operational parameters, which audit changes trail must be built in the supervisory system. These
parameters consist of alarm Setpoint
s
and the action of enabling or disabling the buzzer on the device.
