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FORM-000249184 DI Equipment Software Assessment
FORM-000249184 DI Equipment Software Assessment
Instructions: Complete the following assessment under the guidelines of the Data Integrity Directive (10.1.GDIR). If no is selected for any of
the assessment questions, resolve and document corrective actions.
A. General
B. User Access
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CONTROLLED DOCUMENT TD-GEN-FRM-094 Status: Effective Effective Date: 16/Aug/2021
Does the system/equipment utilize a unique access control that contains User IDs
14.
in combination with password?
Is unauthorized system access detectable and reportable to organization
15.
management?
Is there an electronic signature that is permanently linked to the electronic
16.
records?
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CONTROLLED DOCUMENT TD-GEN-FRM-094 Status: Effective Effective Date: 16/Aug/2021
Is there a process to ensure that when records are retrieved from archive, the set
5.
of records provided accurately and completely reflect the source set of records?
6. Is the archive process periodically checked to ensure the restoration of all data?
Are the persons responsible for any manual transfers of electronic records to
storage locations independent of the group responsible for the content of the
7. records or are there other reasonable controls in place to assure the integrity of
the transfer, such as second person verification of the accuracy and
completeness of the transfer?
8. Are Disaster Recovery process(s) defied and tested?
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CONTROLLED DOCUMENT TD-GEN-FRM-094 Status: Effective Effective Date: 16/Aug/2021
7. Is there a procedure in place for periodic review and backup of audit trails?
Is the periodic review of the backup of audit trails documented and retained in a
8.
secure location?
Assessed by:
(Sign/Date)
Approved by:
(Sign/Date)
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CONTROLLED DOCUMENT TD-GEN-FRM-094 Status: Effective Effective Date: 16/Aug/2021
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Viewed/Printed: 21 January 2022 8:56:3 AM ** GDMS-D2 Copy-Use per procedure** FORM-000249184 < > Rev 1 >
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CONTROLLED DOCUMENT TD-GEN-FRM-094 Status: Effective Effective Date: 16/Aug/2021
CONTROLLED DOCUMENT
SIGNATURE PAGE
Document Name :FORM-000249184
Document ID :TD-GEN-FRM-094
Viewed/Printed: 21 January 2022 8:56:3 AM ** GDMS-D2 Copy-Use per procedure** FORM-000249184 Rev 1