validation plan template - talktalk web viewstudy centres lookup lists for attribute verification...

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Version Status Date Page

1.0 Commercial in Confidence DD-MMM-YYYY 1 of 20

Document No:Prepared by: Date: DD-MMM-YYYYVersion:

This document was printed 6-May-23. Prior to its use ensure that it is the most current version.

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Document Approval

Name Role Date Signature<Author> Author

ITValidationClient

Document Control

Version Author Date Description1.0 <Author> DD-MMM-YYYY First Version


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Table of Contents

1 Introduction________________________________________________________________5

1.1 Objective______________________________________________________________5

1.2 Scope_________________________________________________________________5

1.3 Definitions_____________________________________________________________5

1.4 References_____________________________________________________________5

2 Responsibilities_____________________________________________________________7

2.1 Approval of deliverables_________________________________________________7

2.2 Validation working parties_______________________________________________7

2.3 Client group responsibilities______________________________________________7

2.4 IT group responsibilities_________________________________________________7

2.5 Validation group responsibilities__________________________________________7

3 System Description__________________________________________________________8

4 Validation Activity Requirements_______________________________________________9

4.1 Validation Approach____________________________________________________9

4.2 Validation Methodology_________________________________________________94.2.1 Validation Plan (VP)_________________________________________________94.2.2 Vendor Audit_______________________________________________________94.2.3 Design Qualification_________________________________________________94.2.4 Installation Qualification (IQ) [OQ Testing and Production]__________________94.2.5 Operational Qualification (OQ)________________________________________104.2.6 Validation Summary Report__________________________________________114.2.7 Validation Change Control___________________________________________114.2.8 Production Qualification (PQ)_________________________________________12

5 Assumptions, Exclusions and Limitations_______________________________________12

5.1 Compliance Requirements______________________________________________12

6 Project Validation Organization_______________________________________________13

7 Validation Documents Required______________________________________________14

7.1 Decommissioning______________________________________________________15

8 Acceptance Criteria_________________________________________________________17

9 Validation Project Milestones_________________________________________________18


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10 On-going Validation Requirements__________________________________________19

10.1 SOPs related to Validation and Development_______________________________19

10.2 Data Preparation______________________________________________________19

10.3 Ongoing Maintenance__________________________________________________19

10.4 Software Updates, Correction Packages and Patches___________________________19


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1 Introduction

1.1 ObjectiveInsert details of the objectives of conducting the Validation Plan. For example, to validate system 1234.

1.2 ScopeInsert a description of the scope of the Validation Plan. The description should include:

Any specific phases on the system implementation Any specific servers that the system will reside on The software development life cycle (SDLC used) A definition of the post implementation validation process

PQ

1.3 DefinitionsProvide the definition of all terms and acronyms.

1.4 ReferencesThis document contains references to one or more of the following SOPs.

Document ID TitleSOP_0100 Implementation Life Cycle SOP

SOP_0101 SOP SOP

SOP_0102 Documentation Standards SOP

SOP_0103 Document Control SOP

SOP_0104 Configuration Specification SOP

SOP_0105 Environmental Naming Conventions SOP

SOP_0106 Incident Reporting SOP

SOP_0107 Access Authorization and Security SOP

SOP_0108 Computer Operations Manual SOP

SOP_0109 Backup and Archival SOP

SOP_0110 Disaster Recovery Plan SOP

SOP_0111 Vendor Audit SOP


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Document ID TitleSOP_0112 Gathering Evidence SOP

SOP_0113 Configuration Management SOP

SOP_0130 Part 11 Conformance SOP

SOP_0200 Validation Determination SOP

SOP_0300 Validation Plan SOP

SOP_0400 Design Qualification SOP

SOP_0401 Code Review SOP

SOP_0402 Unit Testing SOP

SOP_0500 Installation Qualification SOP

SOP_0501 Installation Plan SOP

SOP_0600 Operational Qualification SOP

SOP_0601 Test Plan SOP

SOP_0602 Test Case SOP

SOP_0700 Validation Summary SOP

SOP_0800 Production Qualification SOP

SOP_0900 Validation Change Control SOP

This document contains references to the following documents.

Document ID TitleXXXX_VD_0001 Validation Determination Statement - <system name>

XXXX_US_0001 User Requirements - <system name>


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2 Responsibilities

2.1 Approval of deliverablesThe approval of deliverable documentation as defined in section 8 will be made by;

The Client representative The Validation Manager or a nominated representative The IT Project Manager

2.2 Validation working partiesThe validation exercise will be co-ordinated by a multi-disciplinary team (the Validation Working Party - VWP). The VWP will consist of the following people:

Role Individual DepartmentValidation Manager Validation

Working Party Member IT

Working Party Member Client

2.3 Client group responsibilitiesInsert the specific responsibilities for the client group.

2.4 IT group responsibilitiesInsert the specific responsibilities for the IT group.

2.5 Validation group responsibilitiesInsert the specific responsibilities for the validation group.


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3 System DescriptionThe system description must describe:

The major functions of the system; The interfaces to the system (application and human

interfaces); The operating environment of the production system

including: the servers, the physical location, and the network;

The hardware and software environment including: servers, PCs, network, any peripheral devices specific, and versions of operating system and application software installed.

If the above information is contained in existing documentation, references to these documents may be used.


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4 Validation Activity Requirements

4.1 Validation ApproachThe validation methodology defines the quality management system for implementation of the system. The design, development and unit/ initial system testing phases of the project and associated documentation will be carried out using the following SDLC <insert SDLC references>.

4.2 Validation MethodologyThe following sub-sections describe the methodology utilized to validate the system.

4.2.1 Validation Plan (VP) A Validation Plan [this document] defines the scope of work (activities and deliverables) required to validate a system, and identifies the design documents that will form the basis for: Design, Installation and Operational and Production Qualifications. The VP will describe the project, the system and the sequence of validation activities within the project. The VP will comply with SOP_0300 Validation Plan SOP.

4.2.2 Vendor AuditInsert references to any vendors who will be audited.

Audits will comply with SOP_0111 Vendor Audit SOP.4.2.3 Design Qualification

4.2.4 Installation Qualification (IQ) [OQ Testing and Production]The IQ is a protocol written to provide documented evidence that all key aspects of the computer software and hardware installation have been identified and adhere to company or vendor codes and schedules.For this project the key items are -

Computer Hardwareo Serverso Network o PCs

Software


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o Operating Systemso Databaseo Utility softwareo Application software

Installation Plans and Reportso Configuration datao Static data verification

Supporting documentationThere will be separate approved installation plans that will need to be executed for the production environment to qualify each installation.IQ Reviews will be performed and recorded to confirm that the IQ Acceptance criteria have been achieved.The IQ process will comply with SOP_0500 Installation Qualification SOP.

4.2.5 Operational Qualification (OQ)An Operational Qualification provides documented evidence that the system functions according to the system specifications. The OQ will demonstrate that the configured system conforms to the agreed business process and functional design. Configurations must be finalized and documented in the IQ before the execution of the OQ protocols can begin.The configured system is the system to be validated during OQ, which will be performed according to pre-approved test plans with defined acceptance criteria, using a qualified data set. OQ will generate documented test results that are subject to review and approval. All the OQ test documentation will form part of the validation package.

OQ will confirm that the computerized processes (including manual operations that are formalized through a SOP and are put in place to support the process) perform their required function and meet the agreed business requirement and Functional Requirement Specification. Where local SOPs are developed which supplement or replace the procedures tested during this OQ they should be reviewed by the Validation Working Party. OQ will also ensure that the Business Practices and Procedures complement the software application.


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Test plans will be based on the agreed Functional Requirement Specifications, Business Scenarios, and an analysis of the 'GXP functions' of the systems. Operational test plans and system SOPs will be produced and refined after design and before implementation. These plans, procedures and associated operator training, will be referenced in the validation package. The OQ protocols will encompass the validation of the business processes that support the execution of the software functionality, the decision whether or not to Roll-out the system will be based on the results of the OQ testing.The OQ process will comply with SOP_0600 Operational Qualification SOP.The conclusions of the OQ will be documented in the Validation Summary Report.

4.2.6 Validation Summary ReportAfter the IQ and OQ protocols have been executed, the results of the qualification testing will be summarized in a Validation Summary Report (VSR). This report will be written by the Validation group and will represent the documented evidence for and against considering the system validated and suitable for use in a production environment. The report will also document any constraints or limitations that have been placed on the production use of the system and any corrective actions that must be completed before the system can be utilized in production. The system will be installed in the production environment through the execution of the production installation plan.The VSR will include or reference the regular periodic reviews, Production Qualifications (PQs), for of the system. These PQs will comply with SOP_0800 Production Qualification SOP.The VSR will include or reference a list of corrective actions that are required to be addressed. These will be reviewed prior to approval of the VSR and a process established to manage the actions to completion.

4.2.7 Validation Change ControlValidation Change Control is a formal system by which qualified representatives of appropriate departments will review proposed and emergency changes that might affect the validated status of a computer system, in order to control how authorized changes are implemented.


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The status of the system will be maintained throughout the project, as described in SOP_0900 Validation Change Control SOP. This will include training, security, documentation, and configuration aspects of the system.The first configuration management baseline will be established immediately prior to performing the Unit Test of the system, and so will be considered to be under change management from this point. All specification documents will be considered under formal change control once the first version is approved.Any new versions of configuration units will be reflected in the revised Installation Plan for the production environment. Each change will require a validation assessment to ensure that all changes that are identified as having ‘validation impact’ are properly documented, tested and controlled.

4.2.8 Production Qualification (PQ)Once the system has gone live Production Qualification will be performed at regular intervals to ensure the system is maintained in a validated state. PQs will comply with SOP_0800 Production Qualification SOP. A Production Qualification Protocol will be prepared by the Validation group prior to the system going live.

5 Assumptions, Exclusions and Limitations5.1 Compliance Requirements

Compliance will be achieved if the validation requirements as described within Section 4 have been fulfilled. Validation of the system and related components will be based on compliance requirements referenced as GXP <define the specific GXP references> and any other applicable regulations. The core validation effort will consider requirements specifically as regulated by the US Code of Federal Regulations and the European Union (EU) Guide for Medicinal Products.


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6 Project Validation Organization Teams identified for this project along with the appropriate validation role as defined in SOP_0100 Implementation Life Cycle SOP are listed below.

Group Identifier

Validation V

Client C

Information Technology IT

The Project Validation Organization responsibilities as defined below are to:

define the validation standards develop, maintain and communicate the validation plan create detailed definition of validation tasks develop review and/or maintain Protocols, Test Plans and

Test Cases as necessary co-ordinate, guide, evaluate, assist, and monitor progress

of validation assign responsibilities for validation in accordance with

the standard operating procedures ensure project compliance though reviews, audits, etc. recommend, as necessary, the formation of additional

validation teams consider and apply appropriate standards, including

regulatory expectations work with the software suppliers and consultants, as

required for successful validation develop, maintain and communicate the validation

summary report.

Document preparation accountability for the groups is defined in SOP_0100 Implementation Life Cycle SOP.


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7 Validation Documents RequiredThe following is a list of validation deliverables organized by the appropriate validation protocol. The table also presents the primary responsibility for document preparation, approval, and the controlling SOP (Standard) for format and content. Review and approval responsibilities are defined in SOP_0100 Implementation Life Cycle. Documents that are not separately approved but are referenced and attached to a controlling DQ, IQ, OQ and PQ protocols will be approved when the controlling protocol is approved. These documents are designated, as ‘NR’ not required in the ‘Approve’ column. All documents will be assembled as the validation package, be archived on suitable media and made available to local sites for reference as required, for planning changes, local inspections, etc. Where text in the following table is highlighted in italics this identifies the Software Development Life Cycle document equivalent.

Deliverables Phase Prepare Approve Standard

Validation Determination Statement Initiation V C,V,IT SOP_0200

Validation Plan Initiation V C,V,IT SOP_0300

User Requirements Specification Concept C,IT C,IT SDLC

Functional Requirements Specification Concept C,IT C,V,IT SDLC

Request for Proposal (If required)

Vendor Audit Report (if required) Initiation V C,V,IT SOP_0111

Design Qualification (DQ) Design V C,V,IT SOP_0400

Technical Specifications Design IT V,IT SDLC

Programming or Coding Procedure Design IT SDLC

Configuration Specification Design IT C,V,IT SOP_0104

Environmental Naming Conventions Design IT IT SOP_0105

Code Reviews Design IT V,IT SOP_0401

Unit Tests Design IT V,IT SOP_0402

Configuration Management Plan Design IT V,IT SOP_0113

Installation Qualification - OQ Installation OQ

V C,V,IT SOP_0500

Installation Plan(s) Installation OQ IT V,IT SOP_0501


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Deliverables Phase Prepare Approve Standard

Installation Report Installation OQ IT V,IT SOP_0501

Installation Qualification (Approved) Installation OQ IT C,V,IT SOP_0500

Operational Qualification OQ V C,V,IT SOP_0600

System Test Plan(s) OQ V C,V,IT SOP_0601

System Test Cases & Results OQ V C,V,IT SOP_0602

Disaster Recovery Plan OQ IT C,V,IT SOP_0110

Operational Qualification (Approved) OQ V C,V,IT SOP_0600

Computer Operations Manual OQ IT C,V,IT SOP_0108

Installation Qualification - Production Installation Production

V C,V,IT SOP_0500

Installation Plan(s) Installation Production

IT V,IT SOP_0501

Installation Report Installation Production

IT V,IT SOP_0501

Installation Qualification (Approved) Installation Production

IT C,V,IT SOP_0500

Application Access Matrix Form Installation Production

IT C,V,IT SOP_0107

Validation Summary Report Installation Production

V C,V,IT SOP_0700

Production Qualification (Pre-Approved)

Operational V C,V,IT SOP_0800

Incident Reports Operational IT V,IT SOP_0106

Incident Log Operational IT V,IT SOP_0106

Validation Change Control Forms Operational V C,V,IT SOP_0900

Production Qualification (Approved) Operational V C,V,IT SOP_0800

Reason Codes Description

NR (Not Required) This is used where individual document approval is not required but the content will be reviewed and approved as part of the validation document that references it.

7.1 DecommissioningState if any existing systems are expected to be decommissioned as part of this process.


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8 Acceptance CriteriaThe system will be deemed acceptable when the Validation Summary Report has been satisfactorily completed and approved and it states that the system is in a validated state. The approval of the VSR includes the following criteria:

It has been demonstrated that the User Requirements, as defined in the Functional Requirements Specifications, have been satisfied including that the system performs reproducibly and consistently within its full range of operating functionality.

All known problems are documented and resolved. Any constraints concerning the release of the system to

production are documented. All essential documents have been adequately produced,

reviewed, and approved.


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9 Validation Project MilestonesThe following table provides an overview of the validation milestones for the system.

MilestoneUser Requirements Specification (Concept Statement) Approved

Validation Determination Statement Approved

Validation Master Plan Approved

Vendor Audits Complete and reports Approved

Vendor Selected

Design Qualification Approved

Installation Qualification (OQ Testing) Approved

Operational Qualification Approved

Installation Qualification (Production) Approved

Validation Summary Report Approved

Production Qualification (Pre-approved)


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10 On-going Validation Requirements

10.1 SOPs related to Validation and DevelopmentThe Validation Methodology will be conducted according to the list of SOPs identified in the reference section. These SOPs will be used to cover the project activities and to provide a framework to ensure that the deliverables contain sufficient detail to allow validation of the system. Insert a reference to the SDLC used and the scope covered by the SDLC.

10.2Data PreparationEnsuring accuracy of data in the initial system is an essential part of validation. Initial population of system data will be sourced from the following classifications:New Static Data (data constants or look-up table values that are required by the new system but do not exist in current systems, verified for correctness before entry and after the data has been entered into the system). Examples of New Static Data are:

Study Centres

Lookup lists for attribute verification

Trial lifecycle data

Existing Static Data (data constants that are manually or automatically converted from existing systems will be verified for correctness before entry and after the data has been entered into the system).

10.3Ongoing MaintenanceThe Validation Team will verify plans for maintenance of the hardware and software before the systems go live. The Validation Team will verify that each business department with responsibility for use of the system has change control in place before the systems go live.

10.4Software Updates, Correction Packages and PatchesUpgrades or updates (including correction packages or “patches”) of the operating system software, database or Application software, with new versions, shall be assessed for


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validation impact through change control prior to use and consideration shall be given to re-validation of the system.
