Compliance With 21 Cfr, Part 11; Introduction; Identification And Authentication Of Users; Automatic Log-Off - Airplane VCR 1002 Manual De Instrucciones Y Mantenimiento

Fabrication Nº:
Equipment:
OPERATING INSTRUCTIONS AND MAINTENANCE MANUAL

9.7 COMPLIANCE WITH 21 CFR, PART 11

9.7.1

Introduction

Equipment control system has been developed according to the 'Code of Federal
Regulations' CFR (Title 21, part 11), in compliance with the following requirements:
Users are identified and authenticated before allowing use of the equipment.
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All actions of the users involved in equipment use for manufacturing are
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documented and confirmed by electronic signature.
All operator actions requiring mandatory traceability are recorded and stored in
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a file (Audit Trail)
Thus it is guaranteed the complete traceability of the user who has performed each
operation, the time of execution and, if necessary, the reason for the action.
Also, the system ensures that the user's operation records are not counterfeit and
can be consulted when necessary.
 Equipment has the appropriate modules to comply with 21 CFR (part
11). Nevertheless, 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,...)
9.7.2

Identification and authentication of users

To access the program it is required that the user is identified with a user name and
password. The program comes with 4 default users with different permission levels:
Operator, Operator2, Maintenance and Admin
on user's permissions).
 IMPORTANT!
Passwords are personal and not transferable. It is user's responsibility to
ensure the proper use of them.
After 3 attempts to access with wrong passwords, the user will be
automatically transferred to the group of "unauthorized" and will not be
permitted to log-in again.
Passwords are valid for 90 days and after, the system will require its
change. In order to ensure the confidentiality of passwords, they may
not be reused until have passed 270 days from its use (two consecutive
password changes).
9.7.3

Automatic log-off

To avoid program access and handling by unauthorized users, each user has a
configurable time for automatic log-off, after which, if user has not taken any action
or no buttons are pressed, the session expires and it is necessary to log-in again.
 Default log-off time is 5 minutes. It can be only modified by
Administrator (ADMIN) user through User Settings screen
9.6.8) .
Ref. ProJect / Revision: 721021-07 / R01
721021-70-1 / 721021-70-3
VESSEL FOR CREAMS – Mod. VCR 1002 / MELT TANK – Mod. MET 0400
(see section 9.6.8 for further details
Client: UNIPHARMA
Date: 11-2015
EN
ES
MDI VCR (v1.0)
(see section
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