Camille Bauer LINAX A325, Руководство по эксплуатации

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Advanced Graphic Data Manager Commissioning and use during operation
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6.8 Meeting the requirements of 21 CFR 11
6.8.1 General notes
Prior to using electronic signatures, a hand-signed letter should be sent to the
Office of Regional Operations (HFC–-100)
5600 Fishers Lane
Rockville, MD 20857
USA
informing it that the company intends to use electronic documents/signatures in the future.
Administrators and users have to be trained on 21 CFR 11 or already have to be knowledgeable in
this field. Commercial software that is used in electronic recording systems in accordance with 21
CFR 11 must be validated. The suitability of the unit and the related PC software (incl. operating
system) for the required application has to be defined, validated and documented (e.g. with regard
to data confidentiality, printing device parameters, backup copies of the set parameters, assigning
access authorization in the PC software, suitability of the software commercially used – such as the
operating system etc.).
Prior to assigning/specifying the electronic signature (or elements of this electronic signature such
as a unique ID/initialization password), the identity of the person in question has to be verified. The
administrator has to ensure that IDs are unique and assigned correctly to the appropriate parties and
must document this information. Electronic signatures may only be used by the legitimate users.
They may not be disclosed to third parties. The administrators and users must be committed to
ensuring the user IDs and passwords (including the initialization passwords) are not abused.
Procedural requirements stating that each individual will be held responsible for any action taken
using his/her signature must be defined and observed to have a mechanism in place to act as a
deterrent to document and signature forging. To meet the requirements of the FDA with regard to
21 CFR 11 compliance, please ensure that the correct settings for the unit and related PC software
are made. Suitable controls have to put in place with regard to the system documentation
(distribution, access and use of the documentation for operating and maintaining the system).
Revision and change control processes have to be put in place for the system documentation (audit
trail documenting the advancement of, and modifications to, the system documentation over time).
The system is not designed for use in Internet applications/open systems.
6.8.2 Important PC software settings
Compliance with the requirements of 21 CFR 11 demands certain functions in the related PC
software. In particular, settings have to be made that automatically record PC software access and
operation in an audit trail.
Notes:
• Only use operating systems with user administration (e.g. MS Windows® NT/2000/XP).
• Activate user administration, audit trail recording and password protection as per 21 CFR Part 11:
"Extras –> Program options –> Setup" select "General", "Audit trail activate recording" switch to
"Security", click "Protected by" and "Password protection per FDA 21 CFR Part 11".
• Assign the permitted rights to the users: click "User administration"; new users can be added here.
Recommendation: password valid for 60 days to prevent the user getting used to the password.
• Where applicable, use the powerful automatic functions of the PC software (e.g. automatic
readout, automatic backup function, automatic alarm by e-mail). Note: this requires a series
connection to a PC that has to work in the automatic mode. Detailed instructions are provided
on the CD-ROM of the PC software supplied.