Tevapharm India Private Limited: (DD - Mm.yyyy Hh:mi:ss)

Tevapharm India Private Limited General Procedures
SOPG018024/2
Valid from: 03.04.2020
COMPUTER SYSTEM
VALIDATION
Goa Information Technology
Date/Time: Author:
(dd.mm.yyyy hh:mi:ss)
19.03.2020 11:07:18 Gaunekar Bhupesh, Sr. Executive-IT
Date/Time: Approved by:

(dd.mm.yyyy hh:mi:ss)
21.03.2020 07:01:02 Kamat Sushant, Sr Manager - IT

30.03.2020 04:44:40 Wali Veerendra, Group Leader Quality Assurance
Supersedes:
SOPG018024/1
1565215
Training is required for this version
This document has been electronically signed, UTC time Page 1 of 59

Tevapharm India Private Limited General Procedures
SOPG018024/2
COMPUTER SYSTEM VALIDATION
1 PURPOSE
1.1 To describe a procedure for GxP Computer system validation.
2 SCOPE
2.1 This procedure is applicable for all local GxP Computerized systems at goa site.
3 RESPONSIBILITY
3.1 Business owner is owner of the system (including associated data).The Business owner
is accountable for assessment of the system, its business application, defining the user
requirements, the system validation and the maintenance of the validated state.
3.2 Technical Owner is responsible for delivering the system that meets the requirements of
the business and maintain the system in accordance with defined procedures to support
its validated state.
3.3 Quality Assuranceis Quality Assurance is responsible for assuring the compliance of
business, technical and user requirement with appropriate regulations.
4. HEALTH, SAFETY AND ENVIRONMENT

NA
5. DEFINITION
5.1 GxP Computerized Systemis Computerized system that are subjected to GxP
regulations. Computer systems that store parameters or run data on permanent storage
that is used for GxP purpose.
6. PROCEDURE
6.1 Numbering system for different Templates
6.1.1 Document number for URS
6.1.1.1 URS document number should be as per the SOPG002107
6.1.2 Document numbering for FS, VP,FRA,IQ,OQ,PQ, HDSCS,DRP,VSR
This document has been electronically signed, UTC time Page 2 of 59

6.1.2.1 Numbering Format : XX/Software ID/ZZ
XX : short form of documents( as per the abbreviation mentioned below)
Abbreviations Document Name
FS Functional Specification
VP Validation Plan
FRA Functional Risk Assessment
IQ Installation Qualification
OQ Operational Qualification
PQ Performance Qualification
TM Traceability Matrix
VSR Validation Summary Report
HDS Hardware design and configuration
specification
DRP Disaster Recovery Plan
Software id – ID of the software as per the

SOPG017396 ZZ- Version number start from 00
/ - separator
6.1.2.2 TO shall maintain the document numbering log for Test Defect Form as per
the Annexure 14
6.1.3 Document numbering for Test Scripts and Test Defect Form
6.1.3.1 Document Numbering Format for Test
scripts Format : Software ID/ZZZ/XXX
Software id – ID of the software
ZZZ - short form of test script (as per abbreviation mentioned below)
IQT –for Installation qualification test
OQT- for Operational Qualification test
PQT- for Performance qualification
test
And XXX is running test number start with 001,002...
6.1.3.2 Document numbering Format for Defect Form

Format : DEF/ZZZZ
Where DEF- Defect and ZZZZ- Running number start with 0001
6.1.3.3 The Technical owner shall maintain the document number for defect form as per the
Annexure 14
6.1.4 For performing the CSV any one of the below mentioned protocols should be used
6.1.4.1 Global Validation pack/ Protocols- Protocols or validation pack which are readily
available with the Teva global team. This type of protocol shall be used as it is and
no changes are allowed to this protocols
6.1.4.2 Vendor supplied protocols- Protocols/ Validation packs may be used in lieu of Teva-
Generated documents. Such documents are not required to have the exact format
as Teva documents if the general contents remain the same. Teva may choose to
augment the vendor-supplied documents with any additional information needed
(eg.pre-approval page, post approval page).Vendor –supplied protocols and reports
are subjected to the same approval as Teva-generated protocols and reports for the
same topic.
6.1.4.3 Site protocols – Site protocols shall be used as defined in this
SOP. Additional test sections may be added as necessary to appropriately
documents and test the system.
6.1.5 Prior to the approval of Validation Plan, A GxP Assessment has to be done as per
Addendum ADR006527 to identify whether the system is GxP or Non GxP System.
6.1.6 CSV deliverable shall be executed as per the flow defined below
URS FS HDSCS VP FRA IQ OQ PQ
VSR&TM
6.2 User Requirement Specification (URS)
6.2.1 The representative of BO shall be responsible for preparing and approving the URS
of software application as per the Annexure 1
6.2.2 URS should define clearly and precisely what the user wants the system to do.
6.2.3 URS should include the system functionality and 21 CFR part 11 Requirements.
6.3 Functional Specification (FS)
6.3.1 The representative of BO Shall prepare and approve the FS as Per the
Annexure 2
6.3.2 The FS documents defines clearly and precisely what the system or features of the
system must do to meet the each requirement from the URS.
6.4 Hardware Design and Configuration Specification(HDSCS)
6.4.1 TO Shall prepare and approve the HDSCS as Per the Annexure 3
6.5 Validation Plan
6.5.1 The TO shall prepare the Validation Plan as per the Annexure 4
6.5.2 The VP should include the validation approach and and the process how the
validation activity will be performed.
6.5.3 The VP should clearly define the roles and responsibility of the TO, BO and QA.
6.5.4 The VP should mention the physical and logical arrangements, data flows of the
GxP computerized system in the system architecture.
6.6 Functional Risk Assessment
6.6.1 The TO shall prepare the Risk Assessment as per the Annexure 5
6.6.2 The risk analysis and risk evaluation shall be done as per the SOPG011427 “ Risk
Assessment Computerized System”
6.7 IQ/OQ/PQ Protocol
6.7.1 IQ Protocol
6.7.1.1 The TO shall prepare the Installation Qualification Protocol as per the Annexure 6
Below are the typical IQ Test for Computer Systems wherever applicable but not
limited to:
Document verification
Software configured verification- Verify that all applicable software is present
and installed
Shut down and start up test- Execute the shutdown and start-up
procedure(S), and verify the orderly star-up and shutdown of hardware.
Power verification supply requirements- Verify by visual inspection that
required power type is supplied to instrument and the computer
Environmental verification- Verify that proper room management in in place
to maintain the environment in operating conditions
Emergency Power verification- If an uninterruptible power supply (UPS) is
required for the system, verify that its applicable components are connected
to an UPS.
6.7.2 OQ Protocol
6.7.2.1 The TO shall prepare the Operational Qualification Protocol as per the Annexure 7
6.7.2.2 Below are the typical OQ Test for Computer Systems wherever applicable but not
limited to
Operating System compliance
System Time Control-
Application Compliance
User profile and privileges
Data Security
Data modification or deletion
Backup and Restore
Audit Trail
Electronic signature configuration
6.7.3 PQ Protocol
6.7.3.1 The representative of BO shall prepare the Performance Qualification Protocol as
per the Annexure 8
6.7.3.2 Below are the typical PQ Test for Computer Systems wherever applicable but not
limited to
SOP and Document verification
Operation Functionality
Reports
Electronic signature ( if applicable)
6.8 Instructions for Completing the Test Script
6.8.1 The test scripts shall be prepared as per the Annexure 10 and to be attached to the
relevant IQ/OQ/PQ document
6.8.2 All entries must be recorded legibly applying Good documentation practices, as per
site procedure.
6.8.3 Test Defects arising during the execution of the protocol shall be recorded
according to the procedure described in the Section 6.9 on Test Defect
management.
6.8.4 For each action, enter “PASS” in the Pass/Fail column only if the actual result
exactly matches the relevant expected result, described in the “Expected Result”
column; otherwise enter “FAIL” in this column
6.8.5 Any Test step evidence required (as indicated in the evidence required column)
shall be provided in the form of screenshots, files or system printouts.
6.9 Test Defect Management
6.9.1 In the case of a negative result for a test action or any discrepancy, a CSV Defect
Form Annexure 12 shall be used.
6.9.2 The first part of the CSV Defect Form is the details of the found Defect with a brief
description.
6.9.3 The second part is the Test Defect Evaluation .The defect shall be evaluated by the
BO in coordination with the TO according to its impact/severity based upon below
criteria, and the actual corrective actions taken to resolve the defect are to be listed.
Defect Description
Classification
Execution Error An error attributed to protocol executor not following or

understanding the execution instructions as written and
approved.
Functionality Error An error attributed to malfunction of the system during testing
Protocol Error An error attributed to incorrect protocol test, test or script

step sequencing
6.9.4 The last part of the Form (“Defect Closure”) is to record the implemented corrective
action of the system.
6.9.5 Test Re Runs

In the event of a test fail, and the satisfactory resolution of the associated Test
Defects, the test may be re-run. The test run number should be incremented by 1
and recorded on all relevant test scripts during this re-run. Executed test script
results and any associated Test Defects will be reported in the VSR.
6.9.6 The Test Defect form is not required in below cases:
6.9.7 The defect is a typographical error or execution error that either does not affect the
meaning of the protocol, test, step or expected results. This type of defects can be
corrected directly on the document by adding the proper comments.
6.9.8 All corrections and comments must be initialized and dated and must comply with
good documentation practice.
6.10 Validation Summary Report and Traceability Matrix
6.10.1 This document should summarizes the validation activities and the results of the
testing cycle conducted.
6.10.2 This document should include a summary of the overall validation activities and the
testing for the system.
6.10.3 A Traceability matrix should be a part of the VSR or a separate document.
Requirements defined in URS and FS should be traceable to successfully executed
tests.
6.10.4 The Technical owner shall prepare the Validation summary report as per the
Annexure 9
6.11 Disaster Recovery Plan
6.11.1 The TO, in coordination with the BO and QA, shall responsible for preparation of
disaster recovery plan after the releases of the system but not more than 90 days.
6.11.2 DRP shall be prepared once the system is released for the use.
6.11.2 Appropriate global templates shall be use to prepare DRP or as per the annexure
13.
6.12 Data Migration Plan
6.12.1 The data migration shall be done in below cases
whenever the existing system is upgraded to the new versions of the
software
in case of reinstallation of the software on existing pc/server
6.12.2 Prior to data migration TO shall check with the vendor, whether the data can be
migrated or not .Incase if data cannot be migrated than the existing system will be
kept as per the record retention policy.
6.12.3 Data migration activity/test can be included in OQ or PQ protocol if applicable or a
separate plan shall be prepared by the TO as per the appropriate Global Templates.
6.12.4 The BO shall be responsible for verification of migrated data.
6.12.5 Data migration activity shall be performed prior to release of the system or after
release of the system depending upon the size and type of data.
6.13 Training
6.13.1 Prior to execution of the any protocols , user need to trained on the protocol and
training details need to be updated in the annexure 11
6.13.2 The author of the protocol shall impart the training.
6.13.3 The Training Record shall be retained with the Validation documents.
7. ADDENDUMS
Addendum # Title of Addendum
NA NA
8. ANNEXURES
Annexure # Title of Annexure Format No.

SOPG018024/T1/00
Annexure 1 User Requirement Specification
Annexure 2 Functional Specification SOPG018024/T2/00
Annexure 3 Hardware Design and Configuration SOPG018024/T3/00

Specification
Annexure 4 Validation Plan SOPG018024/T4/00
Annexure 5 Functional Risk Assessment SOPG018024/T5/00
Annexure 6 Installation Qualification SOPG018024/T6/00

Annexure 7 Operational Qualification SOPG018024/T7/00
Annexure 8 Performance Qualification SOPG018024/T8/00
Annexure 9 Validation Summary SOPG018024/T9/00
Annexure 10 Test Scripts SOPG018024/T10/00
Annexure 11 Training Log SOPG018024/T11/00
Annexure 12 CSV Defect Form SOPG018024/T12/00
Annexure 13 Disaster Recovery Plan SOPG018024/T13/00
Annexure 14 Log for Numbering of CSV Defect Form SOPG018024/T14/00
REFERENCES
9.
SOPG002495 : System Development Life Cycle

SOPG011414 : Computerized System Policy
SOPG003383 : Electronic records and Electronic signatures
SOPG011427 : Risk Assessment (Computerized System)
10. ABBREVIATIONS
IT: Information
Technology BO : Business
Owner
TO : Technical Owner
URS: User Requirement
Specification FS: Functional
Specification
HDSCS : Hardware Design and Configuration Specification
VP: Validation Plan
IQ- Installation Qualification
OQ- Operational Qualification
PQ: Performance
Qualification UAT: User
Acceptance Test DRP:
Disaster Recovery Plan
VSR: Validation summary Report
FRA: Functional Risk
Assessment QA: Quality
Assurance
11. REVISION HISTORY
Change HISTORY OF REVISIONS

Ver. Effective
control
# Date Reason for change Summary of change
No.
25/03/2019 To be in line with CAPA New SOP.
1 1186823
1116085
Current To be in line with CAPA Point number 6.5.4 is added

2 1565215
version valid 1535050 to include the procedure to
from date mention the physical and
on the SOP logical arrangements, data
flows, of the GxP
computerized system in the
validation plan
<Yellow highlighted Text within this document must be edited and /or
deleted>
Annexure 1
User Requirement Specification (URS)

System Name: XXXXX
Document Number: XX Version No. XX Page: X of X
User Requirements Specifications
(URS) Of
<System Name>
SOPG018024/T1/00
System Name: XXXXX
Document Version History
Version Date Author Change History
Review & Approvals
Approval Name and Designation Department Signature and Date
Prepared By
Reviewed By
Approved By
SOPG018024/T1/00
System Name: XXXXX
Table of Contents
# Contents Page
Number
1 Introduction
1.1 Purpose
1.2 Scope
1.3 Applicable SOPs
1.4 Internal Reference Documents
1.5 Definitions and Abbreviations
2. Overview
2.1 Background
2.2 Main system Function and Intended – Use
3 System User Requirements
3.1 Requirements Matrix
3.1.1 General Requirements
3.1.2 Regulatory Requirements
3.1.3 Process Requirements
SOPG018024/T1/00
System Name: XXXXX
1. Introduction
1.1 Purpose
The purpose should describe the rationale/justification for the protocol and the
objectives.
1.2 Scope
The Scope should define the boundaries of the activities identified in the protocol.
1.3 Applicable SOPs
Mention the applicable SOPs
Mention the applicable references documents
The following is a list of abbreviations which are used in this document
2.Overview
2.1 Background
< Describe the background of the project. > such as:
Currently, Teva does not have a <system> <system / tool> for managing <proposed
system's main functionality>. Teva is facing a significant increase in <main object of the
system>, and it will be difficult to manage all these <objects> without a computerized
system.
2.2 Main system Function and Intended Use
<Describe the Main System functions of the new system>
3 System User Requirements
Requirements are linked to general characteristics and features expected from the
system and /or to system Hardware and Software components. The specific required
requirements are detailed in the following Requirements Matrices.
3.1 Requirements Matrix
The requirements are structured according to the following typologies:
General Requirements
Regulatory Requirements
Process Requirements
General Requirements are linked to general characteristics and features expected from
the system and /or to system Hardware and Software components.
Regulatory Requirements are the provisions set forth by regulations determined as
applicable.
Process Requirements are directly linked to the processes managed by the computer
system.
The specific required requirements are detailed in the following Requirements Matrices.
SOPG018024/T1/00
System Name: XXXXX
3.1.1 General Requirements

The General requirements are reported in the table below.
# Requirement Name Requirement Description
UGR-001 <xxx> <XXX>
UGR-002 <xxx> <XXX>
3.1.2 Regulatory Requirements

The Regulatory requirements are reported in the table below.

URR-001 <xxx> <XXX>
URR-002 <xxx> <XXX>
3.1.3 Process Requirements
The Process requirements are reported in the table below.

UPR-001 <xxx> <XXX>
UPR-002 <xxx> <XXX>
SOPG018024/T1/00
deleted>
Annexure 2
Fuctional Specification (FS)

System Name: XXXXX
Document
XXXXX Version No. XX Page X of X
Number:
Functional Specifications
(FS) OF
<System Name>
SOPG018024/T2/00
System Name: XXXXX
Document
Number: XXXXX Version No. XX Page X of X

XX XXX XX XX
Review & Approvals
Approval Name and Department Signature and Date

Designation
Prepared By
Reviewed By
Approved By
SOPG018024/T2/00
System Name: XXXXX
Document
Table of Contents
# Contents Page
Number
1 Introduction
1.1 Purpose
1.2 Scope
1.3 Applicable SOPs
2 Overview
2.1 Background
2.2 Main system Function and Intended – Use
3 System Functions
3.1 Main system Functions
4 Traceability Matrix
5 Constraints
SOPG018024/T2/00
System Name: XXXXX
Document
Number:
1.Introduction
1.1 Purpose
This document is the Functional Specification (FS) document, which will identify and
specify the requirements for the Software for <System Name>in the <Department>,
<Site Name>
1.2 Scope
1.3 Applicable SOPs
# Acronym Acronym Description
2.Overview
2.1 Background
system.
3 System Functions
system and /or to system Hardware and Software components. Process Requirements
are directly linked to the processes managed by the computer system.
<Describe the main functions, which are in the scope of this FS with at a high level,
Process flows should be used where applicable.>
SOPG018024/T2/00
System Name: XXXXX
Document
Number:
4. Traceability Matrix
The following Traceability Matrix assures traceability between User Requirements and
Functional Specifications
URS# URS Subject URS Requirement FS# FS Title

Description
5. Constraints
<Include here the additional information regarding Constraints, which was not included
in the URS document. In case the URS includes all the information, refer to the URS
document’s relevant section.>
SOPG018024/T2/00
deleted>
Annexure 3
Hardware Design and configuration Specification (HDSCS)

System Name: XXXXX
Document
Number:
Hardware Design and configuration Specification

(HDSCS) Of
<System Name>
SOPG018024/T3/00
System Name: XXXXX
Document
Number:

XX XXX XX XX
Review & Approvals

Designation
Prepared By
Reviewed By
Approved By
SOPG018024/T3/00
System Name: XXXXX
Document
Number:
Table of Contents
# Contents Page
Number
1 Introduction
1.1 Purpose
1.2 Scope
1.3 Applicable SOPs
2 Overview
2.1 Background
3 System Functions
3.2 System Architecture
3.3 Hardware Configuration
3.4 Software Configuration
3.5 Security Parameters
4 Data storage
5 Instrument Environment
6 Attachment
SOPG018024/T3/00
System Name: XXXXX
Document
Number:
1.Introduction
1.1 Purpose
This document is the Hardware Design and Configuration Specification (HDSCS)
document, which will identify and specify the requirements for the Software for
<System Name>in the <Department>, <Site Name>
1.2 Scope
1.3 Applicable SOPs
2.Overview
2.1 Background
system.
3 System Functions
system and /or to system Hardware and Software components. Process Requirements
are directly linked to the processes managed by the computer system.
SOPG018024/T3/00
System Name: XXXXX
Document

<Describe the main functions, which are in the scope of this HDSCS with at a high level,
Process flows should be used where applicable.>

Mention the Architecture of the system
3.3 Hardware Configuration
Mention the minimum recommended hardware and actual hardware information
3.4 Software Configuration
Mention the minimum recommended software configuration
3.5 Security Parameters
Mention the Windows security parameters and application software security
parameters
4 Data Storage
Mentioned the configuration of the database
5 Instrument Environment
Mentioned the environment parameters like operating temperature, RH, power supply.
6 Attachment
Use the table below to list any attachment to this HDSCS
Attachment Related Description No. pages Initial/Date
number HDSCS
section
SOPG018024/T3/00
deleted>
Annexure 4
Validation Plan
System Name: XXXXX
Document Number: XX Version No. XX Page X of X
Validation Plan
Of
<System Name>
SOPG018024/T4/00
Validation Plan
System Name: XXXXX

XX XXX XX XX
Review & Approvals

Designation
Prepared By
Reviewed By
Approved By
SOPG018024/T4/00
Validation Plan
System Name: XXXXX
Table of Contents
# Contents Page
Number
1 Introduction
1.1 Purpose
1.2 Scope
1.3 Applicable Sops
1.5 Definitions And Abbreviations
2. Overview
2.1 Background
2.2 Main System Function And Intended – Use
3 System Description Overview
4 Organizational Structure
4.1 Roles And Responsibilities
5 Validation Strategy
5.1 Overview
5.2 Validation Concept And Approach
5.3 Traceability
6 Validation Activities And Deliverables
6.1 Required Activities And Documentation Deliverable
7 Acceptance Criteria
8 Sops
9 Training
10 Documentation Management
11 Maintenance Of The Validation State
12 Retirement Of The System
SOPG018024/T4/00
Validation Plan
System Name: XXXXX
1Introduction
1.1 Purpose
This document is the Validation Plan (VP) document, which will identify and specify the
requirements for the Software for <System Name>in the <Department>, <Site Name>
1.2 Scope
1.3 Applicable SOPs


# Acronym Acronym
Description
2.Overview
2.1 Background
system.
3 System Description Overview
<Describe the background of the system/business processes>
3.1 System Architecture.
4 Organizational Structure
4.1 Roles and Responsibilities
<The most common Roles and Responsibilities are specified in the table below. At least,
one Business Owner, one Technical owner and one QA Owner, must approve each
validation deliverable>.
SOPG018024/T4/00
Validation Plan
System Name: XXXXX
5 Validation Strategy
5.1Overview
5.2 Validation Concept and Approach
<mentioned the Validation Concept and Approach>
5.3 Traceability
In order to demonstrate that the system meets the defined User Requirements and
Functional Specifications, all the requirements shall be traceable to successfully
executed tests.
6. Validation Activities And Deliverables

6.1Required Activities And Documentation Deliverable
< all the responsibilities of the project's team in reference with the validation activities
and deliverables should mentioned>
7 Acceptance Criteria
<Mentioned the acceptance criteria>
8 Sops
<SOPs regarding system's use and business management should be created and
approved by the business before the system is operational in the new site>
9 Training
<Describe the training administration that shall be given for the system. For existing
systems, in case of retrospective validation, the requirement can be limited to the
verification of training records for current user>
10 Documentation Management
<Include where/who is planned to archive validation documentation>
11 Maintenance of the Validation State
<Mention the procedure for Maintenance Of The Validation State >
12Retirement of the System
<Mention the procedure for Retirement of the System>
SOPG018024/T4/00
deleted>
Annexure 5
Functional Risk Assesment

System Name: XXXXX
Functional Risk Assessment
OF
<System Name>
SOPG018024/T5/00
System Name: XXXXX

XX XXX XX XX
Review & Approvals

Designation
Prepared By
Reviewed By
Approved By
SOPG018024/T5/00
System Name: XXXXX
Table of Contents
# Contents Page
Number
1 Introduction
1.1 Purpose
1.2 Scope
1.3 Applicable SOPs
2. Overview
2.1 Background
3 Risk Assessment
4 Responsibility
5 Functional Risk Assessment
SOPG018024/T5/00
System Name: XXXXX
1Introduction
1.1 Purpose
objectives.
1.2 Scope
1.3 Applicable SOPs

2.Overview
2.1 Background
system.
3. Risk Assessment
4 Responsibility
Mention the Responsibility
5 Functional Risk
Risk Relevance Mode Cause Effect

Priority
Risk Mitigation
Detectability
Severity
Class
Likelihood
ID
SOPG018024/T5/00
deleted>
Annexure 6
Installation Qualification
System Name: XXXXX
Document Number: XX Revision No. XX Page X of X
Of
<Ssystem Name>
SOPG018024/T6/00
System Name: XXXXX

XX XXX XX XX
Review & Approvals

Designation
Prepared By
Reviewed By
Approved By
SOPG018024/T6/00
System Name: XXXXX
Table of Contents
# Contents Page
Number
1 Introduction
1.1 Purpose
1.2 Scope
1.3 Applicable SOPs
1.5 Definitions and abbreviations
2 Overview
2.1 Background
2.2 Main Function and Intended -Use
3 Test List
4 Execution Team Members
5 Discrepancy and Corrective Action
6 Conclusion
7 Review and Post Approval
8 Supporting Documentation
SOPG018024/T6/00
System Name: XXXXX
1 Introduction
1.1 Purpose
objectives.
1.2 Scope
1.3 Applicable SOPs
List the abbreviations used in this document
2.Overview
2.1 Background
system.
2.2 Main Function and Intended –Use
3. Test List
Test Code Test Object Number of Pages

4. Execution Team Members
Mention the name of team members
5. Discrepancy and Corrective Action
Mention the discrepancy and corrective action if any
6. Conclusion
7. Review and Post Approval
8. Supporting Documentation
SOPG018024/T6/00
deleted>
Annexure 7
Operational Qualification
System Name: XXXXX
OF
<System Name>
SOPG018024/T7/00
System Name: XXXXX

XX XXX XX XX
Review & Approvals

Designation
Prepared By
Reviewed By
Approved By
SOPG018024/T7/00
System Name: XXXXX
Table of Contents
# Contents Page
Number
1 Introduction
1.1 Purpose
1.2 Scope
1.3 Applicable SOPs
2 Overview
2.1 Background
3 Test List
6 Conclusion
SOPG018024/T7/00
System Name: XXXXX
1Introduction
1.1 Purpose
objectives.
1.2 Scope
1.3 Applicable SOPs
2.Overview
2.1 Background
system.
3. Test List
6. Conclusion
SOPG018024/T7/00
deleted>
Annexure 8
Performance Qualification
System Name: XXXXX
OF
<System Name>
SOPG018024/T8/00
System Name: XXXXX

XX XXX XX XX
Review & Approvals

Designation
Prepared By
Reviewed By
Approved By
SOPG018024/T8/00
System Name: XXXXX
Table of Contents
# Contents Page
Number
1 Introduction
1.1 Purpose
1.2 Scope
1.3 Applicable SOPs
2 Overview
2.1 Background
3 Test List
6 Conclusion
SOPG018024/T8/00
System Name: XXXXX
1Introduction
1.1 Purpose
objectives.
1.2 Scope
1.3 Applicable SOPs
2.Overview
2.1 Background
system.
3. Test List
6. Conclusion
SOPG018024/T8/00
deleted> Annexure 9
Validation Summary Report

System Name: XXXXX
Of
<System Name>
SOPG018024/T9/00
System Name: XXXXX

XX XXX XX XX
Review & Approvals

Designation
Prepared By
Reviewed By
Approved By
SOPG018024/T9/00
System Name: XXXXX
Table of Contents
# Contents Page
Number
1 Introduction
1.1 Overview
1.2 Scope
1.3 Applicable SOPs
2 Validation Summary
3 Plan Execution
3.1 Project Performance
3.2 Traceability Matrix
4 Testing Result Summary
5 Deviation Reporting and Resolutions
6 ER/ES Compliance
6.1 System Security
6.2 Data Reliable and Integrity
6.3 Electronic Signature
6.4 Data Availability
7 Training
8 Maintenance of Validated state
8.1 Maintenance of SOP
8.2 System Requirements
9 Conclusion
SOPG018024/T9/00
System Name: XXXXX
1Introduction
1.1 Overview
1.2 Scope
1.3 Applicable SOPs
2.Validation Summary
3. Plan Execution
3.1 Project Performance
3.2 Traceability Matrix
<A Traceability Matrix (TM) is issued in order to provide a direct correlation between
requirements and system tests. It helps in assuring that all requirements are properly
addressed>
4.Testing Result Summary
<Mention the testing result summary>
5. Deviation Reporting and Resolutions
6. ER/ES Compliance
6.1 System Security
6.2 Data Reliable and Integrity
6.3 Electronic signature
6.4 Data Availability
7. Training
8.Maintance of Validated State
8.1 Maintained of SOP
8.2 System Requirements
9. Conclusion
SOPG018024/T9/00
deleted>
Annexure 10
IQ /OQ/PQ Test Cases
System Name: XXXXX

Test ID Run
Test Name
Test
Objective\Description
Acceptance Criteria
Reference <URS number>
Specifications
Test Pre requisites
Step Description Expected Actual Evidence Pass/Fail Initials &

Result Result Required/ Date
Attachment
ID
1 <XXXX>> <XXXX>> Yes/NO
Attachment
ID
Comments
TESTING EXECUTION RESULTS DEFECT

PASSED �FAILED � YES �NO � Defect ID :
Name Title Signature
and Date
Tester
Reviewer
SOPG018024/T10/00
Training Record
Annexure 11
Signature Training
Record
This list will capture signature of all personnel involved in the data gathering ,verification or the
review process that have not already signed as a preparer,reviwer or approver .Responsible
individuals must be identified with name , full signature and written initials and department or
company represented.
Completion of signature Training log confirms that the individual understands the relevant test
sections with respect to the protocol requirements. In the case of
Non-Teva employees, the full name of the organization to which they are affiliated must be
included in their details.
Name Signature Initials Department or Company Date Trainer sign
SOPG018024/T11/00
Annexure 12
CSV Defect Form
Software ID
Testing Phase : IQ OQ PQ Other:
Defect ID Test Name
Defect Description
Test Completed YES NO

Tester Name Name and Designation Signature and Date
Defect Evaluation
Defect Protocol Error Execution Error Functionality Error
Classification
Recommneded Corrective Action
Name and Designation Signature and Date

Reviwed By BO
Reviwed By TO
Approved By
QA/Designee
Defect Closure
Changes YES NO Re YES NO NA
Implemented NA Executed
Test
Implemented Corrective Action/Followup
Open Closed Rejected

Defects status
Other
Name and Designation Signature and Date
Reviwed By BO
Reviwed By TO
Approved By
QA/Designee
SOPG018024/T12/00
deleted>
Annexure 13
Disaster Recovery Plan (DRP)

System Name: XXXXX
Disaster Recovery
Plan OF
<System Name>
SOPG018024/T13/00
System Name: XXXXX

XX XXX XX XX
Review & Approvals

Designation
Prepared By
Reviewed By
Approved By
SOPG018024/T13/00
System Name: XXXXX
Table of Contents
# Contents Page
Number
1 Introduction
1.1 Purpose
1.2 Scope
1.3 System Description Overview
2. Roles And Responsibilities
3 DRP Methodology Overview
3.1 Methodology
3.2 System Components
3.2.1 Software Profile
3.2.2 Hardware Profile
4 Backup and Recovery Procedure
SOPG018024/T13/00
System Name: XXXXX
1Introduction
1.1 Purpose
This document is the Disaster Recovery Plan document, which will identify and specify
the requirements for the Software for <System Name>in the <Department>, <Site
Name>
1.2 Scope
1.3 System Overview
2. Roles and Responsibility

Mentioned the role and responsivity of responsible personnel
3. DRP Methodology
3.1 Methodology
Describe the methodology used for Disaster Recovery planning of the system
3.2 System Components

3.2.1 Software Profile
Mentioned the available software components of the system
3.2.2 Hardware Profile
Mentioned the available hardware components of the Systems
4. Backup and Recovery procedure

Mentioned the Backup and Recovery Procedure use at site
SOPG018024/T13/00
Annexure 14
Log for Numbering of CSV Defect Form
Software ID Document Number Allotted by Sign and date
SOPG018024/T14/00

Tevapharm India Private Limited: (DD - Mm.yyyy Hh:mi:ss)

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Tevapharm India Private Limited General Procedures

Goa Information Technology

19.03.2020 11:07:18 Gaunekar Bhupesh, Sr. Executive-IT

Date/Time: Approved by:

21.03.2020 07:01:02 Kamat Sushant, Sr Manager - IT

Training is required for this version

This document has been electronically signed, UTC time Page 1 of 59

4. HEALTH, SAFETY AND ENVIRONMENT

6.1.1 Document number for URS

6.1.1.1 URS document number should be as per the SOPG002107

6.1.2 Document numbering for FS, VP,FRA,IQ,OQ,PQ, HDSCS,DRP,VSR

This document has been electronically signed, UTC time Page 2 of 59

Software id – ID of the software as per the

6.1.3.2 Document numbering Format for Defect Form

Execution Error An error attributed to protocol executor not following or

Functionality Error An error attributed to malfunction of the system during testing

Protocol Error An error attributed to incorrect protocol test, test or script

6.9.5 Test Re Runs

Annexure # Title of Annexure Format No.

Annexure 2 Functional Specification SOPG018024/T2/00

Annexure 3 Hardware Design and Configuration SOPG018024/T3/00

Annexure 5 Functional Risk Assessment SOPG018024/T5/00

Annexure 6 Installation Qualification SOPG018024/T6/00

Annexure 8 Performance Qualification SOPG018024/T8/00

Annexure 9 Validation Summary SOPG018024/T9/00

Annexure 10 Test Scripts SOPG018024/T10/00

Annexure 11 Training Log SOPG018024/T11/00

Annexure 12 CSV Defect Form SOPG018024/T12/00

Annexure 13 Disaster Recovery Plan SOPG018024/T13/00

Annexure 14 Log for Numbering of CSV Defect Form SOPG018024/T14/00

SOPG002495 : System Development Life Cycle

URS: User Requirement

Specification FS: Functional

HDSCS : Hardware Design and Configuration Specification

VP: Validation Plan

IQ- Installation Qualification

OQ- Operational Qualification

Qualification UAT: User

Acceptance Test DRP:

Disaster Recovery Plan

VSR: Validation summary Report

FRA: Functional Risk

Assessment QA: Quality

Change HISTORY OF REVISIONS

Current To be in line with CAPA Point number 6.5.4 is added

User Requirement Specification (URS)

User Requirements Specifications

Document Version History

Version Date Author Change History

Review & Approvals

Approval Name and Designation Department Signature and Date

3.1.1 General Requirements

3.1.2 Regulatory Requirements

# Requirement Name Requirement Description

# Requirement Name Requirement Description

Fuctional Specification (FS)

Document Version History

Version Date Author Change History

Review & Approvals

Approval Name and Department Signature and Date

URS# URS Subject URS Requirement FS# FS Title

Hardware Design and configuration Specification (HDSCS)

Hardware Design and configuration Specification