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VACCINE RESEARCH SOP PEARL RIVER, NY
TITLE: Data Review Procedures for Direct Luminex 
Immunoassays in LIMS v6Doc. Number:
VR-SOP-LC-11120 Version: 3.0
Doc. Alias: NA
PFIZER CONFIDENTIAL
Page 1
TABLE OF CONTENTS
LIST OF TABLES ................................ ................................ ................................ ..................... 2
1. HISTORICAL REVI SION SUMMARY ................................ ................................ ..............3
2. PURPOSE ................................ ................................ ................................ .............................. 3
3. SCOPE ................................ ................................ ................................ ................................ ...3
4. GLOSSARY ................................ ................................ ................................ .......................... 3
5. GENERAL ................................ ................................ ................................ ............................. 4
6. RESPONSIBILIT IES................................ ................................ ................................ ............5
7. SAFETY ................................ ................................ ................................ ................................ 5
8. MATERIAL S/EQUIPME NT................................ ................................ ................................ 5
8.1. Hardware ................................ ................................ ................................ ................... 5
8.2. Software ................................ ................................ ................................ .................... 5
9. PROCEDURE ................................ ................................ ................................ ........................ 6
9.1. Review of LabWare v6 LIMS Metadata...................................................................6
9.2. Calculation of Assay Results –SAS Analysis ................................ .......................... 7
9.3. Assay  Results Review ................................ ................................ ............................... 7
9.4. LabWare v6 LIMS ................................ ................................ ................................ ....9
9.4.1. Upload of SAS Results ................................ ................................ ................. 9
9.4.2. Result Review ................................ ................................ ............................. 10
9.4.3. ................................ ................................ ..........11
9.4.4. ................................ ....................... 11
9.4.5. Lab Authorization ................................ ................................ ....................... 11
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FDA-CBER-2021-5683-1147635
VACCINE RESEARCH SOP PEARL RIVER, NY
TITLE: Data Review Procedures for Direct Luminex 
Immunoassays in LIMS v6Doc. Number:
VR-SOP-LC-11120 Version: 3.0
Doc. Alias: NA
PFIZER CONFIDENTIAL
Page 29.5. Deviations ................................ ................................ ................................ ................ 12
10. REFERENCES ................................ ................................ ................................ .................. 12
11. DOCU MENT VERSION MODIFIC ATIONS................................ ................................ ..13
11.1. CRI F Number: VR -CRIF-19-14295................................ ................................ .....13
LIST OF TABLES
Table1. Chronological Summary  of Previous Versions................................ ..........3
Table 2. Vaccine Research Functional Units ................................ ............................ 3
Table3. Terms and Definitions................................ ................................ ................ 3
Table4. Roles and Responsibilities................................ ................................ ..........5
Table5. Review Rules for Repeat Tests ................................ ................................ ...9
Table6. General References ................................ ................................ ................... 12
Table7. Form References ................................ ................................ ....................... 13
Table8. Specific References ................................ ................................ .................. 13
Table9. Detailed Changes ................................ ................................ ...................... 13
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FDA-CBER-2021-5683-1147636
VACCINE RESEARCH SOP PEARL RIVER, NY
TITLE: Data Review Procedures for Direct Luminex 
Immunoassays in LIMS v6Doc. Number:
VR-SOP-LC-11120 Version: 3.0
Doc. Alias: NA
PFIZER CONFIDENTIAL
Page 31.HISTORICAL REVISION SUMMARY
Table1.Chronological Summary of Previous Versions
Version # Effective 
DateOriginator Summary
3.0 Current Updated to accommodate procedures for new  method 
and paperless processes.
2.010-Mar-2017 Updatedreferences section.
1.016-Jan-2017 New Document
2. PURPOSE
This document describes the da ta review process for all Direct Luminex I mmunoassay  data 
packages that utilize LabWare v6 LIMS.
3.SCOPE
This procedure applies to the Vaccine Research & Development (VRD) personnel who 
perform data review for Direct Luminex I mmunoassay s in support of clinic al and 
non-clinical studies. The calculation of assay  results and the transfer of these results to 
LabWare v6 LIMS for authorization are in the scope of the procedure.
Table 2.Vaccine Research Functional Units
Functional Units Location
Vaccine Research & Development Pearl River
4.GLOSSAR Y
Table3.Terms and Definitions
Term Definition
CSV comma-separated values file
Assay Plate 96-well microtiter plate used to perform the Luminex assay
Batch
Bio-Plex Bio-Rad proprietary Luminex Suspension Array System and Software
BLQ Below Limit of Quantitation
DAP Data Analysis Portal
dLIA Direct Luminex ImmunoAssay
Lab Authorize The action to approve the data results in LabWare v6 LIMS
LDR Laboratory Deviation Report
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FDA-CBER-2021-5683-1147637
VACCINE RESEARCH SOP PEARL RIVER, NY
TITLE: Data Review Procedures for Direct Luminex 
Immunoassays in LIMS v6Doc. Number:
VR-SOP-LC-11120 Version: 3.0
Doc. Alias: NA
PFIZER CONFIDENTIAL
Page 4Table3.Terms and Definitions
Term Definition
LIMS Laboratory Information Management System
LLOQ Lower limit of Quantitation
Metadata Assay -related information captured in LabWare LIMS (e.g. reagents, equipment, instruments)
MFI Median Fluorescent Intensity
QCS Quality Control Sample
QNS Quantity Not Sufficient
RSS or STD Reference Standard S ample
5.GENERAL
The dLIA measures antigen -specific antibodies in unknown se rum samples .Specific 
antibodies from theserum samples are detected using  secondary  
antibody. The fluorescence signal is directl y proportional to the amount of specific 
antibodies present in the serum.
For assay  plates prepared with the  methods,  
assay plate is equivalent to one batch.
For assay  plates prepared with the  method,  batch contains up to  
assay plates.
For clinical and toxicology  studies, the data reviewer must be qualifi ed on this procedure 
andNOT be the same analy st who has performed laboratory  activities (eg ,robot 
operator) to generate the raw data and/or who has carried out the primary  documentation 
review, if required, upon completion of the appropriate test method.
It is acceptable for the data reviewer to sign off o n batch-related comments in L abWare 
v6 LIMS when necessary.
Following the successful upload of raw data, the results are calculated in Pfizer’s 
proprietary  SAS-based data anal ysis program. The results output file is examined and 
the data is entered into LabWare v6 LIMS. The data reviewer verifies that the results are 
correctly entered and authorizes the results in LabWare v6 LIMS.
In the event that LabWare v6 LIMS is unavailable, sample preparation and assay 
completion worksheets should be filled out to capture the required metadata. These 
worksheets must be scanned into L abWare v6 LIMS and associated with the appropriate 
batch(es) during the data review procedures.
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FDA-CBER-2021-5683-1147638
VACCINE RESEARCH SOP PEARL RIVER, NY
TITLE: Data Review Procedures for Direct Luminex 
Immunoassays in LIMS v6Doc. Number:
VR-SOP-LC-11120 Version: 3.0
Doc. Alias: NA
PFIZER CONFIDENTIAL
Page 56.RESPONSIBILITIES
All personnel and positions referred to in this procedure are considered to have an 
alternate.
An alternate must ensure that they  are trained and knowledgeable with the process.
Table4.Roles and Responsibilities
Role Responsibilities
Analyst Ensures the authenticity, integrity, completeness, accuracy, quality and compliance 
of dLIA data .
Data Reviewer Ensures the authenticity, integrity, completeness, accuracy, quality and compliance 
of dLIAdata.
Processes data w ith Pfizer’s proprietary, custom SA Sprogram.
Performs results entry in LabWare v6 LIMS .
Creates replicate tests in LabWare v6 LIMS .
Performs lab authorization of batches in LabWare v6 LIMS .
InitiatesLDRs, as required .
Supervisor Ensures that the data reviewer is properly trained on the appropriate SOPs .
Ensures all LDRs associated with data packages are closed prior to final QA 
authorization .
7.SAFETY
N/A
8.MATERIALS/EQUIPMENT
8.1.Hardware
Computer
8.2.Software
Active Pfizer Computer Account .
LabWare v6 LIMS user account with a Data Reviewer or La b Manager role; access to 
LabWare v6 LIMS production environment.
Access to the appropriate assay  specific link(s) in the Data Anal ysis Portal.
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FDA-CBER-2021-5683-1147639
VACCINE RESEARCH SOP PEARL RIVER, NY
TITLE: Data Review Procedures for Direct Luminex 
Immunoassays in LIMS v6Doc. Number:
VR-SOP-LC-11120 Version: 3.0
Doc. Alias: NA
PFIZER CONFIDENTIAL
Page 69.PROCEDURE
Data review encompasses three major tasks:
Review of metadata entered in LabWare v6 LIMS; in the event that LabWare v6 LIMS is 
unavailable for metadata entry , the data reviewer should review the sample preparation 
and assay  completion worksheets
Calculation of Assay  Results
Upload of Assay  Results to L abWare v6 LIMS and review of Assay  Results in L abWare 
v6 LIMS
9.1.Review of LabWare v6 LIMS Metad ata
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FDA-CBER-2021-5683-1147640
VACCINE RESEARCH SOP PEARL RIVER, NY
TITLE: Data Review Procedures for Direct Luminex 
Immunoassays in LIMS v6Doc. Number:
VR-SOP-LC-11120 Version: 3.0
Doc. Alias: NA
PFIZER CONFIDENTIAL
Page 79.2.Calculation of Assay Results –SAS Analysis
9.3.Assay Results Review
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FDA-CBER-2021-5683-1147641
VACCINE RESEARCH SOP PEARL RIVER, NY
TITLE: Data Review Procedures for Direct Luminex 
Immunoassays in LIMS v6Doc. Number:
VR-SOP-LC-11120 Version: 3.0
Doc. Alias: NA
PFIZER CONFIDENTIAL
Page 8
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FDA-CBER-2021-5683-1147642
VACCINE RESEARCH SOP PEARL RIVER, NY
TITLE: Data Review Procedures for Direct Luminex 
Immunoassays in LIMS v6Doc. Number:
VR-SOP-LC-11120 Version: 3.0
Doc. Alias: NA
PFIZER CONFIDENTIAL
Page 9Table5.Review Rules for Repeat Tests
9.4. LabWare v6 LIMS
9.4.1.Upload of SAS Results
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FDA-CBER-2021-5683-1147643
VACCINE RESEARCH SOP PEARL RIVER, NY
TITLE: Data Review Procedures for Direct Luminex 
Immunoassays in LIMS v6Doc. Number:
VR-SOP-LC-11120 Version: 3.0
Doc. Alias: NA
PFIZER CONFIDENTIAL
Page 109.4.2.Result Review
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FDA-CBER-2021-5683-1147644
VACCINE RESEARCH SOP PEARL RIVER, NY
TITLE: Data Review Procedures for Direct Luminex 
Immunoassays in LIMS v6Doc. Number:
VR-SOP-LC-11120 Version: 3.0
Doc. Alias: NA
PFIZER CONFIDENTIAL
Page 119.4.3.Apply Single Repeat Code
9.4.4.Complete Batch and Create Replicates
9.4.5.Lab Authorization
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FDA-CBER-2021-5683-1147645
FDA-CBER-2021-5683-1147646
FDA-CBER-2021-5683-1147647
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FDA-CBER-2021-5683-1147648