Promag CON-485 Series Instruções de Operação descarregar pdf (Página 61)

Memo-Graph S 6 Guaranteeing the requirements of 21 CFR 11

Endress+Hauser 61

6 Guaranteeing the requirements of

21 CFR 11

6.1 General

Prior to introducing electronic signatures, a letter, signed by hand, must be sent to the

Office of Regional Operations (HFC-100)

5600 Fishers Lane

Rockville, MD 20857

USA

informing it of the company's intention to use electronic documents/signatures in the future.

Administrators and users must be trained to 21 CFR 11 or must already have appropriate experience

in this area.

Commercial software used in electronic record systems, in accordance with 21 CFR 11, must be

validated.

The suitability of the device and the associated PC software (incl. operating system) for the required

application must be defined, validated and documented (e.g. with regard to data confidentiality,

device parameter print-out, back-ups for configured parameters, assignment of access rights in the

PC software, suitability of the software commercially used - e.g. operating system etc.).

Prior to assigning/specifying the electronic signature (or elements of this electronic signature, e.g.

unique ID/initialisation password), the identity of the individual in question must be verified.

The administrator must ensure that the ID is unique and correctly assigned to the appropriate indi-

vidual and must document this.

Electronic signatures may only be used by the rightful users. They may not be transferred to other

parties. Administrators and users are obliged not to abuse user IDs and passwords (also initialisation

passwords).

Written procedures must be defined and observed specifying that individuals are held accountable

for actions taken under their electronic signature to create a deterrent towards the falsification of

documents and signatures.

To guarantee the requirements of the FDA as regards meeting the 21 CFR 11 criteria, please pay

particular attention to the correct settings for the device and the associated PC software.

A suitable control system for the system documentation must be established (distribution, access

and use of the documentation for system operation and maintenance).

Revision and modification control systems for the system documentation must be established (audit

trail which documents the chronological order of system documentation modification and develop-

ment).

The system is not designed for use in Internet applications/open systems.

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Promag CON-485 Series Instruções de Operação Página 61