CONTROLLED DOCUMENT TD-GEN-FRM-093 Status: Effective Effective Date: 16/Aug/2021

DPE Data Integrity Equipment/Software

Pre-Assessment Questionnaire
(TD-GEN-FRM-093)

Equipment DPE Engineering ID

Description: Number:

Software Name: Revision Level:

Question Yes / No / NA Answer

Yes Proceed to next question.

Is data generated by the electronic
system/software used in the manufacturing
process, analysis of conformance to Stop here. The system is not
specifications or to satisfy a QMS / GMP considered in scope for the DPE
requirement? No Data Integrity
Equipment/Software
Assessment.*

Yes Proceed to next question.

Is data stored electronically?

Stop here. The system is not

Note: Stored data does not refer to a system considered in scope for the DPE
that temporarily collects data that is subsequently No Data Integrity
recorded elsewhere. Equipment/Software
Assessment.*

The DPE Data Integrity

Equipment/Software
Is there a final paper record complete with Assessment is not required as
Yes the paper record can be
minimal / no metadata required from the
electronic data record? considered equivalent to the
electronic record.*

Proceed to DPE Data Integrity

No / NA Equipment/Software
Assessment.
* If not proceeding to DPE Data Integrity Equipment/Software Assessment, then access control,
revision/change control and a review of validation package may still be applicable.

Comments:____________________________________________________________
____________________________________________________________

Assessed by:
(Sign/Date)

Approved by:
(Sign/Date)

Viewed/Printed: 21 January 2022 8:58:9 AM ** GDMS-D2 Copy-Use per procedure** < FORM-000249181 > Rev 1 >
 CONTROLLED DOCUMENT TD-GEN-FRM-093 Status: Effective Effective Date: 16/Aug/2021

DPE Data Integrity Equipment/Software

Pre-Assessment Questionnaire
(TD-GEN-FRM-093)

Note: Revision history is not required to be copied with the form.

Rev: 1 Author: Abigail Bull CR: 000249070

Description of Change: New Form
Implementation Instructions: Upon Document Approval

Viewed/Printed: 21 January 2022 8:58:9 AM ** GDMS-D2 Copy-Use per procedure** < FORM-000249181 > Rev 1 >
 >
CONTROLLED DOCUMENT TD-GEN-FRM-093 Status: Effective Effective Date: 16/Aug/2021

CONTROLLED DOCUMENT
SIGNATURE PAGE
Document Name :FORM-000249181

Document Title :DPE Data Integrity Equipment/Software Pre-Assessment Questionnaire

Document ID :TD-GEN-FRM-093

Signed By Date (GMT) Justification

Storm Bonnie 13/Aug/2021 Quality Approval

12:38:02

Cassidy Darlene M 27/Jul/2021 Author Confirmation

13:38:42

Viewed/Printed: 21 January 2022 8:58:10 AM ** GDMS-D2 Copy-Use per procedure** FORM-000249181 Rev 1