White paper:

Computer System Validation

This Whitepaper will assist and guide you with the

validation of computer systems using GAMP 5
methodologies and is intended to provide an overview of
Computer System Validation (CSV) and a road map of
the deliverables used in the CSV process.

As computer systems are diverse, depending on the type

and size of system, novelty, complexity, and business
impact, the deliverables may be scaled up or down
accordingly.

This document was prepared in November 2021, any content including links and quoted regulation may be out of date. Please refer to the
appropriate source for the most recent information. We endeavour to keep an up-to-date record of information at www.pharmout.net.
©2021 PharmOut. This document has been prepared solely for the use of PharmOut and its clients. Copying is prohibited.
MKT_TMP200_01_r08
PharmOut white paper: Computer System Validation

Introduction
This whitepaper is intended as a guide to assist your organization with Computer System
Validation (CSV) and provides an overview of CSV methodologies and a road map of the
deliverables used in the CSV process. As computer systems are diverse, depending on the type
and size of system, novelty, complexity and business impact, the deliverables may be scaled up
or down accordingly.
The CSV process discussed in this whitepaper is based on the GAMP 5 framework, as it provides
an excellent and pragmatic approach for CSV which, when followed, will ensure your
computerized systems are fit for purpose, will meet the needs of your business, and are
compliant with current regulations.

Validation Process
The range of activities required to validate a computerized system is determined by its GAMP 5
software and hardware categorization, GxP impact, applicable electronic records and electronic
signatures requirements, data integrity, and its risk-based lifecycle approach.
There are four life cycle phases of a computer system that are employed by GAMP 5: concept,
project, operation and retirement. Various activities take place in more than one phase, hence a
fifth phase, multi-phase, is documented here to describe these cross-phase activities.

Figure 1: Computer System vs Computerised System

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Concept Phase
System Software and Hardware Categorization
The following GAMP 5 software and hardware categories are used to establish the validation
approach and determine the deliverables:
▪ Category 1 – Infrastructure Software
▪ Category 3 – Non-Configured Products
▪ Category 4 – Configured Products
▪ Category 5 – Custom Applications
▪ Hardware Category 1 – Standard Hardware Components
▪ Hardware Category 2 – Custom Built Hardware Components

GxP Impact Assessment

The GxP impact assessment is carried out to determine if the computer system has an impact
on product quality, patient safety or data integrity. All GxP impact computer systems must
comply with applicable regulatory requirements.

Electronic Records and Electronic Signatures (ERES) Assessment

An assessment is carried out to establish if the system needs to meet the requirements of
electronic records and electronic signatures by determining what electronic records are
created by the system, how those records are maintained and how the records will be signed,
either by hand or electronically.

Project Phase
Supplier Assessment
The system supplier must be assessed to determine their suitability to provide a quality system
that meets all requirements. Confidence will be gained through their adherence to a
documented Pharmaceutical Quality System (PQS) and Software Development Life Cycle
(SDLC).
The assessment may take the form of a basic checklist, a postal questionnaire, or an onsite
audit, depending on the outcome of the risk assessment. Supplier selection should then be
documented in a report, along with whether the supplier documentation will be leveraged or
not.

Risk Management
Risk assessments should be performed at various key stages of the validation process by a
multidisciplinary team so that a full understanding of all processes and requirements are
covered and considered. This helps to identify and manage risks to patient safety, product
quality and data integrity.
An initial risk assessment is conducted early on in the project phase so that the results can be
used in the validation plan, along with the outcome of activities in the concept phase, to define

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the depth and rigour of required activities and compile a list of deliverables. This produces a
validation approach that is commensurate with the level of risk the system poses.
A functional risk assessment is performed following approval of the functional specification
and/or technical documentation, to identify potential risks. Mitigation activities are then planned
to manage the identified risks and allow focusing on critical areas, e.g., by modifying
functionality, detailed testing, procedural controls or training.
Further risk assessments can be performed during the project such as testing and deployment,
and for other activities throughout the life of the system.
A risk assessment uses a simple scoring system documented in a matrix to produce the level of
risk. Depending on the detail of the risk assessment, various types of risk assessment scoring
matrices can be used. Typically, a scoring of 1 to 3 and low, medium and high are used to judge
the severity of the risk, the likelihood of occurrence and the probability of detection to attain an
overall risk level.
Like in any risk assessment methodologies, an effectiveness review of the defined mitigations is
as important. This will ascertain that identified risks are addressed and are low enough to
accept the system’s inherent risks.

Validation Plan (VP)

The Validation Plan (VP) is produced to define the validation approach, describe the required
activities, detail the acceptance criteria and list the deliverables and responsibilities. The VP
specifies how flexible and scalable the validation approach will be which is derived from the
outcome of activities in the concept phase.

System Overview
The system overview is a brief description of the system and includes:
▪ System identification
▪ Business processes the system supports
▪ Data managed by the system
▪ High-level functionality of the system and user interaction
▪ High-level schematic diagram of system architecture/hardware
▪ All interfaces to external systems
▪ How data is secured by physical or electronic means
The system overview may be incorporated into a section of the VP.

User Requirements Specification (URS)

The User Requirements Specification (URS) clearly and precisely states what the user wants the
system to do, what attributes it should have and details any non-functional requirements and
constraints. The following areas should be considered:
▪ Operational and data requirements
▪ Regulatory requirements including ERES
▪ Interfaces

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▪ System access and security

▪ Data handling and reporting
▪ System capability
▪ Environmental health and safety
▪ Supplier support – documentation and testing
The most common mistake in generating a user requirement is that requirements are often
combined. All requirements should be indexed and written one requirement per item. All
requirements should be verifiable and unambiguous. The measurement or acceptance criteria
for these requirements should be defined as part of the approved condition.

Functional Specification (FS)

The Functional Specification (FS) defines the full system functionality including how the user
and business requirements are satisfied. It is the basis for system design, customization,
development and testing. Supplier documentation should be leveraged wherever possible or
referenced from the FS. It must be clear how the requirements are met from the URS and
provide sufficient information to allow the design specification to be written.
The FS may be combined with the URS as a Functional Requirement Specification (FRS).

Configuration Specification (CS)

The Configuration Specification details the configuration parameters and how these settings
address the requirements in the URS. This may be a standalone document or detailed in the FS.

Design Specification (DS)

This activity involves documenting both the hardware and software as a combined document
(DS) or for larger systems as two separate specifications, Hardware Design Specification (HDS)
and Software Design Specification (SDS).
It can be merged with the Functional Specification as the Functional Design Specification (FDS).

Design Review (DR)

Design Reviews (DR) are conducted to verify that the design conforms to required standards;
the FS meets the requirements defined in the URS and that the requirements can be traced
through the design documents in preparation for testing. The output from the risk assessment
is also considered in the review process.
A DR report documents the outcome of the DR process.

Software Development
This is a process where source code is planned and written following pre-defined programming
standards.

Code Review
Where applicable, a code review is performed to detect and fix coding errors before the system
goes into formal testing. It is recommended that all critical functions are verified in this phase. It

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verifies that the software has been developed following the design and programming standards
have been followed.

Data Migration
A Data Migration Plan is created when a system requires data loading from an existing system.
It describes the activities and deliverables required to select, remove, cleanse, migrate and
verify all data to assure its security and integrity.
Data can be manually or automatically loaded/migrated, however, if any critical data has been
manually entered, an evaluation should be carried out to ensure its correctness.

Testing
Testing is carried out to verify that installation and configuration have been conducted in line
with specifications and that the functionality is challenged at the subsystem and system level.
This verifies that system components perform their tasks separately, that the subsystems
integrate correctly, and that the system meets the requirements and expectations of its users.
The testing approach is described in a test plan as either a section within the validation plan or
as a standalone document. Where possible at each stage, any previous testing should be
leveraged, which is defined in the plan. The plan also defines the different types and details the
level of testing (e.g., installation, unit, system, acceptance) that will be required for a project.
The results from the outcome of the risk assessment will define how precise the depth and
rigour of testing shall be and the level of testing will be scaled appropriately. The plan will
specify the test environment (development, test, or production) in which testing shall be
performed, the use of any tools to be employed for testing and test data requirements.
The installation verification, functional verification and requirements verification testing
documents are generated against pre-approved specifications. Test cases are written in test
steps as instructions to be followed to test whether the system satisfies the defined acceptance
criteria appropriate for the test level. The test steps are written in sufficient detail so that
testing is repeatable with consistent results. A printed copy of the approved test case document
is executed, and the test steps are annotated to record the test results. Verification against the
expected result defines whether the test step is a pass or fail. Evidence produced during test
execution (e.g., reports or screen prints) is attached to allow an independent review and
approval of the results. Test results are reviewed, summarized, and approved as a standalone
test report or as part of the executed document.

System Operating Procedures/User Manuals

System Operating Procedures should be written to provide clear unambiguous instructions to
personnel as to the accepted process of completing a particular operation in a systematic,
consistent and safe manner. User manuals should be leveraged wherever possible.

Training
Key users must be trained in the use of the system software, applications, and procedures as
necessary for the development, maintenance, testing and support of the system.

System Support Plan

A System Support Plan defines the supporting organizations and procedures to support and
maintain the quality/validation of the system during its operation phase.
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Service Level Agreement (SLA)

A Service Level Agreement (SLA) documents a mutual agreement for the service provided
between all parties. It should clearly define service, document and data ownership and ensure
accountability, roles and responsibilities are established. The escalation process should be fully
described along with the service performance criteria.

Handover
A plan should be written to define when the application will transition into the operation phase
and how any disruption will be managed. The risk management process could be used in this
process together with a backout plan. It should ensure that project and validation/verification
deliverables are complete before handover.

System Release
When the system is ready to be released for routine use, a certification statement is created
detailing the following:
▪ System name and version
▪ Date of release
▪ Department using the system
▪ The activities and deliverables relating to the release
▪ Restrictions on use (if any)
▪ Open incidents (if any)

Deployment Planning
Deployment activities include the installation, configuration, data migration and testing of the
system and components on the final operating environment (production).

Validation Report (VR)

The Validation Report (VR) summarizes the activities carried out during the project, describes
any deviations, with justification, from the Validation Plan (VP), lists any limitations or
restrictions on use, summarizes any incidents and details any outstanding and corrective
actions.
A certification statement concludes whether the validation was successful or not and approves
or declines the system for its intended routine use.
An Interim Validation Report may be issued if all post-go-live activities are not complete.

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Operation Phase
The computer system is now in operation. For it to maintain its validated status, all aspects of
the system and operating environment must be kept in a documented state of control. The
following activities will assist in this phase.

Backup and Restore

Backup and restore is a routine process consisting of copying software, data and electronic
records to a separate safe and secure area. This information is protected, available and when
required, able to be restored, uncorrupted in its original format.
Backup and restore is not the same as the archiving and retrieval processes.

Continuity Planning and Testing/Disaster Recovery

The continuity plan defines the approach to test all or part of a system’s restoration process.
This verifies the activities required to get a system or its parts in an operating condition again in
the event of a disaster.
Periodic continuity testing should be conducted as a tabletop or full test to verify recovery
processes are up to date. A schedule is created to detail the test type and frequency depending
on system criticality and risk.

Periodic Review
The cumulative effect of changes to a system could affect its validated status. Periodic reviews
are performed to ensure that the computer system remains within both company and
regulatory compliance and is fit for its intended use. The review evaluates the compliance
status of the entire system and plans any required corrective action activities.
The frequency of review depends on such things as system criticality, risk, business impact and
complexity; however, the frequency interval is generally not greater than 3 years.

Data Archive and Retrieval

Data archiving is the process of removing data and electronic records that are no longer actively
used to a separate, secure data storage area for long-term retention. Data that must be
retained for regulatory compliance has to be archived and be available for retrieval when
required.
Records retention requirements should also be considered for the protection, preservation, and
confidentiality of electronic records, including their associated audit trail information.
Archiving and retrieval are not the same as the backup and restore processes.

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Retirement Phase
Decommissioning
A decommissioning plan must be prepared for systems that are to be retired from operational
service so that the process is documented and controlled.
Assessment is required with regards to the archiving of data and records retention
requirements, along with any hardware disposal.

Multi-Phase
Requirements Traceability
Traceability must be documented to identify the connection between the results of the risk
assessment, via the requirements specification, design and through all testing to individual test
cases.

Change Management
The change management process defines the requirements for assessing, documenting, and
managing changes to ensure systems remain validated and applies to software, hardware,
configuration data and documentation.
The process requires all planned and unplanned changes to be planned, assessed, executed,
and closed in a controlled and compliant manner.
Project change control is used to manage changes made to any approved primary design
documents, project scope changes or changes that will affect product quality, patient safety,
data integrity, project cost or schedule.

Incident/Deviation Management
The incident/deviation management process defines the requirements for managing
incidents/deviations for the entire system lifecycle. It details the recording, analysing,
resolution and closure of faults, anomalies and problems that have been identified during the
project phase, testing and operation of the system.
Incident logs should be created to allow the collection and tracking of incidents.

Document Management
The document management process defines the lifecycle controls for documentation including
the creation, review, approval, storage, archiving and distribution of documents. It describes
how documents are classified, named, numbered, and maintained, and also the mechanism for
updating them.
It applies to both hard copy (paper) and soft copy (electronic) documents.

Configuration Management
The configuration management process defines the identification, control and status for
configuration items (e.g., software, objects) which are under change and version control; as well
as the controls, procedures, tools and processes to manage the configuration modifications.
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Access and Security Management

The access and security management process define the requirements for the security and
integrity of a system. Physical and logical security protection mechanisms should secure the
system and data against deliberate or accidental loss, damage or unauthorized change.
Access requests and permissions should be defined with regard to the initiation, authorization,
amending, revoking, recording, and auditing of access rights.

Validation Deliverables Checklist

Required? Complete?
Deliverable
(Yes / No) (x / ✓)

I. Concept Phase

System Software and Hardware Categorization

GxP Impact Assessment

Electronic Records and Electronic Signatures

Assessment

II. Project Phase

Supplier Assessment

Risk Management

Initial Risk Assessment

Functional Risk Assessment

Validation Plan

System Overview

User Requirements Specification

Functional Specification

Configuration Specification

Design Specification

Functional Design Specification

Hardware Design Specification

Software Design Specification

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Required? Complete?
Deliverable
(Yes / No) (x / ✓)

Design Review

Software Development

Programming Standards

Code Review

Data Migration

Test Plan

Factory Acceptance Testing Protocol / Report

Installation Qualification Protocol / Report

Unit and Integration Testing Protocol / Report

System Test Protocol / Report

Operational Qualification Protocol / Report

Acceptance Test Protocol / Report

Performance Qualification Protocol / Report

System Operating Procedures / User Manuals

Training

System Support Plan

Service Level Agreement (SLA)

Handover

System Release

Deployment Planning

Validation Report

III. Operation Phase

Backup and Restore

Continuity Planning / Testing / Disaster Recovery

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Required? Complete?
Deliverable
(Yes / No) (x / ✓)

Periodic Review

Data Archive & Retrieval

IV. Retirement Phase

Decommissioning Plan / Report

V. Multi-Phase

Requirements Traceability

Change Management

Incident / Deviation Management

Document Management

Configuration Management

Access and Security Management

PharmOut Pty Ltd, ABN: 85 117 673 766, Unit 10, 24 Lakeside Drive, Burwood East, Victoria 3151.
Ph: +61 3 9887 6412, Fax: +61 3 8610 0169, Email: info@pharmout.net Web: www.pharmout.net
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References
ISPE GAMP 5, 2008, “A Risk-Based Approach to Compliant GxP Computerized Systems”.

Sources
Links used within this document are prone to change. Please refer to the appropriate source for
the most recent information. We endeavour to keep an up-to-date record of information at
www.pharmout.net

PharmOut is an ISO 9001 certified international GMP consultancy serving the pharmaceutical,
medical device and veterinary industries, as well as related hospital and pharmacy operations.
PharmOut specialises in PIC/S, WHO, United States FDA, European EMA, and Australian TGA
GMP consulting, architecture, engineering, design, project management, training, validation,
continuous improvement and regulatory services.
For more information, please visit www.pharmout.net or contact us at info@pharmout.net.

PharmOut Pty Ltd, ABN: 85 117 673 766, Unit 10, 24 Lakeside Drive, Burwood East, Victoria 3151.
Ph: +61 3 9887 6412, Fax: +61 3 8610 0169, Email: info@pharmout.net Web: www.pharmout.net
©2021 PharmOut. This document has been prepared solely for the use of PharmOut and its clients. Copying is prohibited.
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