Promag CON-485 Series Operations Instructions download pdf (Page 64)

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

64 Endress+Hauser

6.2.5 Analogue inputs

• Select the number of decimal places to suit the measuring range of the sensor/transmitter used.

Note: The accuracy of the device is not increased by selecting more decimal places.

6.3 Important PC software settings

Certain functions are required in the associated PC software in order to meet the requirements of

21 CFR 11. Above all, settings must be made to automatically log PC software access and actions

in what is known as the "audit trail“.

6.3.1 General

• 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 Æ Set up Æ General Æ "Audit Trail activate recording“ and

Æ Extras Æ Program options Æ Set up Æ Security Æ "Password protection activated" and

"Password protection compliant to FDA 21 CFR Part 11“

• Assign the users the permitted rights:

Æ Extras Æ Program options Æ Set up Æ Security Æ "User administration“

Recommended: Password valid for 60 days to prevent the undesired effect of users becoming

used to a password.

• Where useful, avail of the powerful automatic functions of the PC software (e.g. automatic read-

out, automatic back-up function, automatic e-mail alarm – see below)

Note: For this, you require serial connection to a PC which must work in automatic mode.

• If you also require batch logs on paper, for example, in addition to the electronic records (see

below), we recommend you use automatic batch print-out.

Note: Some printers require a new print job per page for this. This function can be activated

under:

Æ Extras Æ Program options Æ Set up Æ Display/Print out (1) Æ "Print-out: start new print

task for each new side“

• With "standard print-out“ print-outs, the related events must be printed out with the measured

values.

Æ Display Æ Print Æ Print-out type Æ Tabular Æ [unit name] (Events)

1 2 ... 59 60 61 62 63 64 65 66 67 68 69 ... 97 98

No comments

Promag CON-485 Series Operations Instructions Page 64