Life Sciences 16.
4
Validation Summary
Report
Document Version 0.1
The Information Company™
Life Sciences 16.4 Validation Summary Report
Contents
1 Purpose........................................................................................................... 4
2 IQ Test Results................................................................................................ 4
3 OQ Test Results.............................................................................................. 5
4 PQ Test Results............................................................................................ 13
5 Traceability Matrix........................................................................................14
6 Conclusion / Recommendations.................................................................14
Appendix 1 – Approved Test Scripts..................................................................15
Revision History................................................................................................... 21
About OpenText............................................................................................. 22
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Life Sciences 16.4 Validation Summary Report
Disclaimer
No Warranties and Limitation of Liability.
Every effort has been made to ensure the accuracy of the features and techniques
presented in this publication. However, Open Text Corporation and its affiliates
accept no responsibility and offer no warranty whether expressed or implied, for the
accuracy of this publication.
Warning: This software is protected by copyright law and international treaties.
Unauthorized reproduction or distribution of this program, or any portion of it, may
result in severe civil and criminal penalties, and will be prosecuted to the maximum
extent possible under the law.
Copyright © 2017 Open Text. All rights reserved. OpenText is a trademark or registered
trademark of Open Text. The list of trademarks is not exhaustive of other trademarks,
registered trademarks, product names, company names, brands and service names
mentioned herein are property of Open Text or other respective owners.
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Life Sciences 16.4 Validation Summary Report
1 Purpose
From __________ through __________, the Life Sciences 16.4 Solutions Validation Test Plan was executed by ______________ to ensure
that the functionality listed in the Life Sciences 16.4 User Requirements Specification and Trace Matrix document is present as part of the
Installation Qualification, Operational Qualifications and Process Qualifications. The purpose of this document is to summarize the results of
the IQ/OQ/PQ.
2 IQ Test Results
The below table summarizes the IQ test results. Refer to Appendix 1 – Approved Test Scripts to review details on the approved Test
Scripts.
Test Script Version (Last Pass/ Comments
Update) Fail
LSS_16.4_Clean_Install
LSS_4.3 to 16.4_Migration - eTMF
LSS_4.3 to 16.4_Migration - Q&M
LSS_4.3 to 16.4_Migration - R&D
LSS_4.3 to 16.4_Migration - SSV
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3 OQ Test Results
The below table summarizes the OQ test results. Refer to Appendix 1 – Approved Test Scripts to review details on the approved Test Scripts.
Test Script Version (Last Pass/ Comments
Phase
Update) Fail
1 LSS_REG_001
1 LSS_REG_002
1 LSS_REG_003
1 LSS_REG_004
1 LSS_REG_005
1 LSS_REG_006
2 LSS_USL_001
2 LSS_USL_002
2 LSS_USL_003
2 LSS_USL_004
2 LSS_USL_005
2 LSS_USL_006
2 LSS_USL_007
2 LSS_USL_008
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Test Script Version (Last Pass/ Comments
Phase
Update) Fail
2 LSS_USL_009
2 LSS_USL_010
2 LSS_USL_011
2 LSS_USL_012
2 LSS_USL_013
2 LSS_USL_014
2 LSS_USL_015
2 LSS_USL_016
2 LSS_USL_017
2 LSS_USL_018
2 LSS_USL_019
2 LSS_USL_020
2 LSS_USL_021
2 LSS_USL_022
2 LSS_USL_023
2 LSS_USL_024
2 LSS_USL_025
2 LSS_USL_026
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Test Script Version (Last Pass/ Comments
Phase
Update) Fail
2 LSS_USL_027
2 LSS_USL_028
2 LSS_USL_029
2 LSS_USL_030
2 LSS_USL_031
2 LSS_USL_032
2 LSS_USL_033
2 LSS_USL_034_ARender
2 LSS_USL_034_Brava
2 LSS_USL_035
2 LSS_USL_036
2 LSS_USL_037
2 LSS_USL_038
2 LSS_USL_039
2 LSS_USL_040
2 LSS_USL_041
2 LSS_USL_042
2 LSS_USL_043
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Test Script Version (Last Pass/ Comments
Phase
Update) Fail
2 LSS_USL_044
2 LSS_USL_045
2 LSS_USL_045_DA
2 LSS_USL_046
2 LSS_USL_047
2 LSS_USL_048
2 LSS_USL_049
2 LSS_USL_050
2 LSS_USL_051
2 LSS_USL_053
3 LSS_RD_MD_001
3 LSS_RDS_001
3 LSS_RDS_002
3 LSS_RDS_003
3 LSS_RDS_004
3 LSS_RDS_005
3 LSS_RDS_006
3 LSS_RDS_007
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Test Script Version (Last Pass/ Comments
Phase
Update) Fail
3 LSS_RDS_008
3 LSS_RDS_009
3 LSS_RDS_010
3 LSS_RDS_011
3 LSS_RDS_012
3 LSS_RDS_013
4 LSS_QM_CP_001
4 LSS_QM_CP_002
4 LSS_QM_CP_003
4 LSS_QM_CP_004
4 LSS_QM_CP_005
4 LSS_QM_CP_006
4 LSS_QM_CP_007
4 LSS_QM_IP_001
4 LSS_QM_MD_001
4 LSS_QMS_001
4 LSS_QMS_002
4 LSS_QMS_003
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Test Script Version (Last Pass/ Comments
Phase
Update) Fail
4 LSS_QMS_004
4 LSS_QMS_005
4 LSS_QMS_006
4 LSS_QMS_007
4 LSS_QMS_008
4 LSS_QMS_009
4 LSS_QMS_010
4 LSS_QMS_011
4 LSS_QMS_012
5 LSS_SSV_001
5 LSS_SSV_002
5 LSS_SSV_003
5 LSS_SSV_004
5 LSS_SSV_005
5 LSS_SSV_006
5 LSS_SSV_007
5 LSS_SSV_008
5 LSS_SSV_009
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Life Sciences 16.4 Validation Summary Report
Test Script Version (Last Pass/ Comments
Phase
Update) Fail
5 LSS_SSV_010
5 LSS_SSV_011
5 LSS_SSV_012
5 LSS_SSV_013
5 LSS_SSV_014
5 LSS_SSV_015
5 LSS_SSV_016
5 LSS_SSV_017
6 LSS_ETMF_001
6 LSS_ETMF_002
6 LSS_ETMF_003
6 LSS_ETMF_004
6 LSS_ETMF_005
6 LSS_ETMF_006
6 LSS_ETMF_007
6 LSS_ETMF_008
6 LSS_ETMF_009
6 LSS_ETMF_010
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Test Script Version (Last Pass/ Comments
Phase
Update) Fail
6 LSS_ETMF_011
6 LSS_ETMF_012
6 LSS_ETMF_013
6 LSS_ETMF_014
6 LSS_ETMF_015
6 LSS_ETMF_016
6 LSS_ETMF_017
6 LSS_ETMF_018
6 LSS_ETMF_019
6 LSS_ETMF_020
6 LSS_ETMF_021
6 LSS_ETMF_022
6 LSS_ETMF_023
6 LSS_ETMF_024
6 LSS_ETMF_025
6 LSS_ETMF_026
6 LSS_ETMF_027
6 LSS_ETMF_028
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Test Script Version (Last Pass/ Comments
Phase
Update) Fail
6 LSS_ETMF_029
6 LSS_ETMF_030
6 LSS_ETMF_031
6 LSS_ETMF_032
6 LSS_ETMF_033
7 LSS_REP_001
7 LSS_REP_002
7 LSS_REP_003
7 LSS_REP_004
7 LSS_REP_005
7 LSS_REP_006
7 LSS_REP_ETMF_001
7 LSS_REP_ETMF_002
7 LSS_REP_QM_003
7 LSS_REP_QM_004
7 LSS_REP_SUB_001
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4 PQ Test Results
The below table summarizes the PQ test results. Refer to Appendix 1 – Approved Test Scripts to review details on the approved Test Scripts.
Test Script Version Pass/Fail Comments
SVS_ETMF_001
SVS_ETMF_002
SVS_QM_001
SVS_QM_002
SVS_RD_001
SVS_RD_002
SVS_SSV_001
SVS_SSV_002
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5 Traceability Matrix
The requirements to test script traceability matrix is provided in the Life Sciences
16.4 Solutions User Requirements Specification and Trace Matrix.
6 Conclusion /
Recommendations
The results of the IQ/OQ/PQ testing demonstrate that the system is functioning
properly and meets all of the requirements as defined in the Requirements
Specification.
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Appendix 1 – Approved Test
Scripts
Pha Test Script Version (Last Approval Comment
se Update) Date s
IQ LSS_16.4_Clean_Install
LSS_4.3 to 16.4_Migration
IQ - eTMF
LSS_4.3 to 16.4_Migration
IQ - Q&M
LSS_4.3 to 16.4_Migration
IQ - R&D
LSS_4.3 to 16.4_Migration
IQ - SSV
OQ -
1 LSS_REG_001
OQ -
1 LSS_REG_002
OQ -
1 LSS_REG_003
OQ -
1 LSS_REG_004
OQ -
1 LSS_REG_005
OQ -
1 LSS_REG_006
OQ -
2 LSS_USL_001
OQ -
2 LSS_USL_002
OQ -
2 LSS_USL_003
OQ -
2 LSS_USL_004
OQ -
2 LSS_USL_005
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Pha Test Script Version (Last Approval Comment
se Update) Date s
OQ -
2 LSS_USL_006
OQ -
2 LSS_USL_007
OQ -
2 LSS_USL_008
OQ -
2 LSS_USL_009
OQ -
2 LSS_USL_010
OQ -
2 LSS_USL_011
OQ -
2 LSS_USL_012
OQ -
2 LSS_USL_013
OQ -
2 LSS_USL_014
OQ -
2 LSS_USL_015
OQ -
2 LSS_USL_016
OQ -
2 LSS_USL_017
OQ -
2 LSS_USL_018
OQ -
2 LSS_USL_019
OQ -
2 LSS_USL_020
OQ -
2 LSS_USL_021
OQ -
2 LSS_USL_022
OQ -
2 LSS_USL_023
OQ -
2 LSS_USL_024
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Pha Test Script Version (Last Approval Comment
se Update) Date s
OQ -
2 LSS_USL_025
OQ -
2 LSS_USL_026
OQ -
2 LSS_USL_027
OQ -
2 LSS_USL_028
OQ -
2 LSS_USL_029
OQ -
2 LSS_USL_030
OQ -
2 LSS_USL_031
OQ -
2 LSS_USL_032
OQ -
2 LSS_USL_033
OQ -
2 LSS_USL_034_ARender
OQ -
2 LSS_USL_034_Brava
OQ -
2 LSS_USL_035
OQ -
2 LSS_USL_036
OQ -
2 LSS_USL_037
OQ -
2 LSS_USL_038
OQ -
2 LSS_USL_039
OQ -
2 LSS_USL_040
OQ -
2 LSS_USL_041
OQ -
2 LSS_USL_042
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Pha Test Script Version (Last Approval Comment
se Update) Date s
OQ -
2 LSS_USL_043
OQ -
2 LSS_USL_044
OQ -
2 LSS_USL_045
OQ -
2 LSS_USL_045_DA
OQ -
2 LSS_USL_046
OQ -
2 LSS_USL_047
OQ -
2 LSS_USL_048
OQ -
2 LSS_USL_049
OQ -
2 LSS_USL_050
OQ -
2 LSS_USL_051
OQ -
2 LSS_USL_053
OQ -
3 LSS_RD_MD_001
OQ -
3 LSS_RDS_001
OQ -
3 LSS_RDS_002
OQ -
3 LSS_RDS_003
OQ -
3 LSS_RDS_004
OQ -
3 LSS_RDS_005
OQ -
3 LSS_RDS_006
OQ -
3 LSS_RDS_007
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Pha Test Script Version (Last Approval Comment
se Update) Date s
OQ -
3 LSS_RDS_008
OQ -
3 LSS_RDS_009
OQ -
3 LSS_RDS_010
OQ -
3 LSS_RDS_011
OQ -
3 LSS_RDS_012
OQ -
3 LSS_RDS_013
OQ -
4 LSS_QM_CP_001
OQ -
4 LSS_QM_CP_002
OQ -
4 LSS_QM_CP_003
OQ -
4 LSS_QM_CP_004
OQ -
4 LSS_QM_CP_005
OQ -
4 LSS_QM_CP_006
OQ -
4 LSS_QM_CP_007
OQ -
4 LSS_QM_IP_001
OQ -
4 LSS_QM_MD_001
OQ -
4 LSS_QMS_001
OQ -
4 LSS_QMS_002
OQ -
4 LSS_QMS_003
OQ -
4 LSS_QMS_004
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Pha Test Script Version (Last Approval Comment
se Update) Date s
OQ -
4 LSS_QMS_005
OQ -
4 LSS_QMS_006
OQ -
4 LSS_QMS_007
OQ -
4 LSS_QMS_008
OQ -
4 LSS_QMS_009
OQ -
4 LSS_QMS_010
OQ -
4 LSS_QMS_011
OQ -
4 LSS_QMS_012
OQ -
5 LSS_SSV_001
OQ -
5 LSS_SSV_002
OQ -
5 LSS_SSV_003
OQ -
5 LSS_SSV_004
OQ -
5 LSS_SSV_005
OQ -
5 LSS_SSV_006
OQ -
5 LSS_SSV_007
OQ -
5 LSS_SSV_008
OQ -
5 LSS_SSV_009
OQ -
5 LSS_SSV_010
OQ -
5 LSS_SSV_011
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Pha Test Script Version (Last Approval Comment
se Update) Date s
OQ -
5 LSS_SSV_012
OQ -
5 LSS_SSV_013
OQ -
5 LSS_SSV_014
OQ -
5 LSS_SSV_015
OQ -
5 LSS_SSV_016
OQ -
5 LSS_SSV_017
OQ -
6 LSS_ETMF_001
OQ -
6 LSS_ETMF_002
OQ -
6 LSS_ETMF_003
OQ -
6 LSS_ETMF_004
OQ -
6 LSS_ETMF_005
OQ -
6 LSS_ETMF_006
OQ -
6 LSS_ETMF_007
OQ -
6 LSS_ETMF_008
OQ -
6 LSS_ETMF_009
OQ -
6 LSS_ETMF_010
OQ -
6 LSS_ETMF_011
OQ -
6 LSS_ETMF_012
OQ -
6 LSS_ETMF_013
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Pha Test Script Version (Last Approval Comment
se Update) Date s
OQ -
6 LSS_ETMF_014
OQ -
6 LSS_ETMF_015
OQ -
6 LSS_ETMF_016
OQ -
6 LSS_ETMF_017
OQ -
6 LSS_ETMF_018
OQ -
6 LSS_ETMF_019
OQ -
6 LSS_ETMF_020
OQ -
6 LSS_ETMF_021
OQ -
6 LSS_ETMF_022
OQ -
6 LSS_ETMF_023
OQ -
6 LSS_ETMF_024
OQ -
6 LSS_ETMF_025
OQ -
6 LSS_ETMF_026
OQ -
6 LSS_ETMF_027
OQ -
6 LSS_ETMF_028
OQ -
6 LSS_ETMF_029
OQ -
6 LSS_ETMF_030
OQ -
6 LSS_ETMF_031
OQ -
6 LSS_ETMF_032
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Pha Test Script Version (Last Approval Comment
se Update) Date s
OQ -
6 LSS_ETMF_033
OQ -
7 LSS_REP_001
OQ -
7 LSS_REP_002
OQ -
7 LSS_REP_003
OQ -
7 LSS_REP_004
OQ -
7 LSS_REP_005
OQ -
7 LSS_REP_006
OQ -
7 LSS_REP_ETMF_001
OQ -
7 LSS_REP_ETMF_002
OQ -
7 LSS_REP_QM_003
OQ -
7 LSS_REP_QM_004
OQ -
7 LSS_REP_SUB_001
PQ SVS_ETMF_001
PQ SVS_ETMF_002
PQ SVS_QM_001
PQ SVS_QM_002
PQ SVS_RD_001
PQ SVS_RD_002
PQ SVS_SSV_001
PQ SVS_SSV_002
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Revision History
Revised Version Revised By Revision Description
Date
18-Jun-2018 0.1 Stephen Initial draft for LS 16.4; ready for client review / approval.
Belcher
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