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Tracebility Matrix

This document is a requirement traceability matrix (RTM) for laboratory computerized systems. It lists 26 system requirements and traces them to specifications, risk assessments, verification test cases, and equipment details. The RTM links requirements to documents like the user requirements specification, system requirement specification, software design specification, risk plan, and verification test procedures. It was created and approved by various departments to track requirements and ensure compliance.

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mkm969
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102 views

Tracebility Matrix

This document is a requirement traceability matrix (RTM) for laboratory computerized systems. It lists 26 system requirements and traces them to specifications, risk assessments, verification test cases, and equipment details. The RTM links requirements to documents like the user requirements specification, system requirement specification, software design specification, risk plan, and verification test procedures. It was created and approved by various departments to track requirements and ensure compliance.

Uploaded by

mkm969
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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REQUIREMENT TRACEBILITY MATRIX FOR LABORATORY COMPUTERIZED

SYSTEMS
Document Number: CSV-RTM-001 Effective Date: Version: 00

REQUIREMENT TRACEBILITY MATRIX FOR


LABORATORY COMPUTERIZED SYSTEMS

Page 1 of 4
REQUIREMENT TRACEBILITY MATRIX FOR LABORATORY COMPUTERIZED
SYSTEMS
Document Number: CSV-RTM-001 Effective Date: Version: 00

1.0 Approval Table

Department Name Department/Designation Signature/Date

Prepared by

Zastra IT Solutions
Consultant

Reviewed by

System Owner-IT

Process Owner-QC

Quality Assurance

Approved by

Quality Assurance

CHANGE HISTORY
Revision Effective Date Description of Change
00 First Issue

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REQUIREMENT TRACEBILITY MATRIX FOR LABORATORY COMPUTERIZED
SYSTEMS

Document Number: CSV-RTM-001 Effective Date: Version: 00

S. No Reference Specifications Risk ASSESMENT Verification test case Remarks


URS No
SRS SDS Risk Plan GXP FRA IQ OQ
1 NA NA CSV- CSV-GXP-001 CSV-FRA-001 IQP-TSS-001 OQP-TSS-001
CSV-SRS-001
FRA-001 HPLC
2 NA NA CSV- CSV-GXP-002 CSV-FRA-002 IQP-TSS-002 IQP-TSS-002
CSV-SRS-002
FRA-002 GC
3 NA NA CSV- CSV-GXP-003 CSV-FRA-003 IQP03-TSS-001 OQP03-TSS-001
CSV-SRS-003
FRA-003 OQP03-TSS-002 ED-207
4 NA NA CSV- CSV-GXP-004 CSV-FRA-004 IQP04-TSS-001 OQP04-TSS-001
CSV-SRS-004
FRA-004 OQP04-TSS-002 ED-192
5 NA NA CSV- CSV-GXP-005 CSV-FRA-005 IQP05-TSS-001 OQP05-TSS-001
CSV-SRS-005
FRA-005 OQP05-TSS-002 ED-132
6 NA NA CSV- CSV-GXP-006 CSV-FRA-006 IQP06-TSS-001 OQP06-TSS-001
CSV-SRS-006
FRA-006 OQP06-TSS-002 ED-173
7 NA NA CSV- CSV-GXP-007 CSV-FRA-007 IQP07-TSS-001 OQP07-TSS-001
CSV-SRS-007
FRA-007 OQP07-TSS-002 ED-195
8 NA NA CSV- CSV-GXP-008 CSV-FRA-008 IQP08-TSS-001 OQP08-TSS-001
CSV-SRS-008
FRA-008 OQP08-TSS-002 ED-138
9 NA NA CSV- CSV-GXP-009 CSV-FRA-009 IQP09-TSS-001 OQP09-TSS-001
CSV-SRS-009
FRA-009 OQP09-TSS-002 ED-139
10 NA NA CSV- CSV-GXP-010 CSV-FRA-010 IQP10-TSS-001 OQP10-TSS-001
CSV-SRS-010
FRA-010 ED-188
11 NA NA CSV- CSV-GXP-011 CSV-FRA-011 IQP11-TSS-001 OQP11-TSS-001
CSV-SRS-011
FRA-011 ED-070
12 NA NA CSV- NA NA NA IQP12-TSS-001 NA ED-253

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REQUIREMENT TRACEBILITY MATRIX FOR LABORATORY COMPUTERIZED
SYSTEMS

Document Number: CSV-RTM-001 Effective Date: Version: 00

SDS-
001
13 NA NA CSV- NA CSV-FRA-012 IQP13-TSS-001 OQP12-TSS-001
NA FRA-012 ED-008
14 NA NA CSV- NA CSV-FRA-013 IQP14-TSS-001 NA
CSV-SRS-011
FRA-013 ED-168
15 NA NA NA NA NA NA IQP15-TSS-001 NA ED-113
16 NA NA NA NA NA NA IQP16-TSS-001 NA ED-156
17 NA NA NA NA NA NA IQP17-TSS-001 NA ED-200
18 NA NA NA NA NA NA IQP18-TSS-001 OQP13-TSS-001
ED-166
19 NA NA CSV- CSV-GXP-012 CSV-FRA-014 IQP19-TSS-001 OQP14-TSS-001
CSV-SRS-012
FRA-014 OQP14-TSS-002 ED-191
20 NA NA CSV- CSV-GXP-013 CSV-FRA-015 IQP20-TSS-001 OQP15-TSS-001
CSV-SRS-013
FRA-015 OQP15-TSS-002 ED-194
21 NA NA CSV- CSV-GXP-014 CSV-FRA-016 IQP21-TSS-001 OQP20-TSS-001
CSV-SRS-014
FRA-016 OQP20-TSS-002 ED-111
22 NA NA CSV- CSV-GXP-015 CSV-FRA-017 IQP22-TSS-001 OQP16-TSS-001
CSV-SRS-015
FRA-017 ED-212
23 NA NA CSV- NA CSV-FRA-018 IQP23-TSS-001 OQP17-TSS-001
CSV-SRS-016
FRA-018 ED-178
24 NA NA NA NA NA NA IQP24-TSS-001 NA ED-171
25 NA NA CSV- CSV-GXP-016 CSV-FRA-019 IQP25-TSS-001 OQP18-TSS-001
CSV-SRS-017
FRA-019 ED-239
26 NA CSV- CSV-GXP-017 CSV-FRA-020 IQP26-TSS-001 OQP19-TSS-001
NA CSV-SRS-018
FRA-020 ED-240

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