Document text
Template Version: January 2021 Confidential Page 1of 2Pfizer Regulatory Quality Assurance
Audit Certificate
I, the undersigned, confirm and certify that the following inves tigator site audit activities were performed.
Study C4591001
Two (2) investigator site audits we re performed between 17-Jun-2021 a nd 02-Sep-2021 for Study C4591001.
Investigator NameCenter
NumberCountry Dates of AuditType of
AuditName of Auditor
Rupp, Richard Earl 1142 United States 21 Jun 2021 to 24 Jun 2021 Routine Cutler, Robert
Rodriguez, Hector A 1156 United States 26 Jul 2021 to 30 Jul 2021 Routine Jilla, Abilash
U
Approver:
Cecilia Gabarain
Senior Director, Re gulatory Quality A ssurance
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Template Version: January 2021 Confidential Page 2of 2
DocUUID : b0287ef5-0954-425a-8b83-0a621b96c796REASON: I approve this
document.REASON: I attest to the accuracy
and integrity of this document.
7997eefb-6feb-4dbc-a232-c15936633467
09 Nov 2021 14:20:012-0500
6809829b-f9ec-4ac9-bc23-e28cfba721dc
09 Nov 2021 14:59:023-0500
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Validation Report
1
Subject CN TAIGLE LLC
Subject DN [email protected],CN=TAIGLE LLC,OU=MSB,O=TAIGLE LLC,L=Irvine,ST=California,C=US
Email [email protected]
Serial # 19482482486555712400772614192179934953
Issuer DN CN=Entrust Class 3 Client CA - SHA256,OU=(c) 2015 Entrust, Inc. - for authorized use only,OU=See www.entrust.net/legal-terms,O=Entrust,
Inc.,C=US
Signing Time 09 Nov 2021 14:59:023-0500
The Certificate chain was successfully built to a Trusted Root Certificate.
The Signer's identity is valid.
The Document has not been modified since the signature was appl ied.
This page was added to the original document by the MSB Validat ion Service (SVS) as part of the process to convert
active signature block content into inactive text. A full validation report of each signature is generated and cross-
referenced using a numeric footnote annotation.
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Audit Trail Report
Document Name C4591001_Audit_Cert_ 09_Nov_21.pdf
Document ID b0287ef5-0954-425a-8b83-0a621b96c796
Time Stamp User Action Details
DocUUID : b0287ef5-0954-425a-8b83-0a621b96c79609 Nov 2021 14:16:057-0500
UU D :
Email
IP Address : StartedThe custodian composed the ePak succesfully.
Subject: C4591001_Audit_Cert_ 09_Nov_21 ePak UUID: e2a8d6b1-47a6-453e-b0c4-f500508de662
09 Nov 2021 14:16:057-0500Robert N Cutler UU D : 7997eefb-6feb-4dbc-a232-c15936633467
Email : robert cutler@pfizer comRequestSent Sign request sent to ePak recipient.
09 Nov 2021 14:19:054-0500Robert N Cutler
UU D : 7997eefb-6feb-4dbc-a232-c15936633467 Email : robert cutler@pfizer com
IP Address : 148.168.96.26DocumentViewed Document viewed by signer.
09 Nov 2021 14:20:012-0500Robert N Cutler
UU D : 7997eefb-6feb-4dbc-a232-c15936633467 Email : robert cutler@pfizer com IP Address : 148.168.96.26SignerTagFilledThe signer filled Time Stamp. Value: 09 Nov 2021 14:20:012-0500
09 Nov 2021 14:20:012-0500Robert N Cutler
UU D : 7997eefb-6feb-4dbc-a232-c15936633467
Email : robert cutler@pfizer com IP Address : 148.168.96.26SignedThe recipient signed the document with no comments. Comments: None Reason: None Consent: I understand that my Electronic Signature is Equivalent
to my Handwritten Signature and is therefore legally binding. M y
Electronic Signature will remain unique to me, and under no
circumstance I am allowed to disclose my password to any individual which may allow unauthorized access to system. I understand that I am accountable and responsible for all action s
associated with my Electronic Signature.
09 Nov 2021 14:20:012-0500
UU D
Email EPakStateChanged The ePak progressed to the next workflow state .
09 Nov 2021 14:20:012-0500Cecilia Beatriz Gabarain
UU D : 6809829b-f9ec-4ac9-bc23-e28cfba721dc
Email : ceciliabeatriz [email protected] Sign request sent to ePak recipient.
09 Nov 2021 14:58:012-0500Cecilia Beatriz Gabarain UU D : 6809829b-f9ec-4ac9-bc23-e28cfba721dc
Email : ceciliabeatriz [email protected]
IP Address : 148.168.40.123DocumentViewed Document viewed by signer.
09 Nov 2021 14:59:023-0500Cecilia Beatriz Gabarain UU D : 6809829b-f9ec-4ac9-bc23-e28cfba721dc Email : ceciliabeatriz [email protected]
IP Address : 148.168.40.123SignerTagFilledThe signer filled Time Stamp.
Value: 09 Nov 2021 14:59:023-0500
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FDA-CBER-2022-5812-0500300
DocUUID : b0287ef5-0954-425a-8b83-0a621b96c79609 Nov 2021 14:59:023-0500Cecilia Beatriz Gabarain
UU D : 6809829b-f9ec-4ac9-bc23-e28cfba721dc Email : ceciliabeatriz [email protected]
IP Address : 148.168.40.123SignedThe recipient signed the document with no comments. Comments: None
Reason: None Consent: I understand that my Electronic Signature is Equivalent to my Handwritten Signature and is therefore legally binding. M y
Electronic Signature will remain unique to me, and under no
circumstance I am allowed to disclose my password to any
individual which may allow unauthorized access to system. I understand that I am accountable and responsible for all action s
associated with my Electronic Signature.
09 Nov 2021 14:59:023-0500
UU D
Email Completed The ePak is completed successfully.
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