Eric J.

Silva
eric@ericsilva.org
01 March 2013
Agenda
 Introduction
 Target Audience
 Background
 Responsibilities & SOPs
 The Validation Process
 Software Development Lifecycle (SDLC)
 Computer System Development SOPs

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Introduction
 The purpose of this presentation is to give the
audience an overview of:
 What is Computer System Validation (CSV)
 Why is CSV needed
 What processes are needed for CSV

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Target Audience
 Developers of computer systems applications
 Users of computer systems involved in testing and
validation activities
 Personnel involved in computer systems procurement
 All concerned managers, auditors, and regulatory
personnel
 Personnel involved in the maintenance of computer
systems

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Background
 In 1987 the FDA published a document entitled ‘FDA
Guidelines on General Principles of Process Validation’
 It states the following:
 Process validation is establishing documented evidence
which provides a high degree of assurance that a specific
process will consistently produce a product meeting its
predetermined specifications and quality attributes.

This definition indicates that validation can

apply to any process including process
managed / controlled by computer systems.

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What is Computer System Validation

The purpose of the validation process is to provide a high

degree of assurance that a specific process (or in this case
computer system) will consistently produce a product (control
information or data) which meets predetermined
specifications and quality attributes.

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Why is Validation Needed
 FDA regulations mandate the need to perform Computer System Validation and these
regulations have the impact of law.

 Failing an FDA audit can result in FDA inspectional observations (“483s”) and warning
letters.

 Failure to take corrective action in a timely manner can result in shutting down
manufacturing facilities, consent decrees, and stiff financial penalties.

 The ultimate result could be loss of jobs, indictment of responsible parties (usually the
officers of a company), and companies suffering economic instabilities resulting in
downsizing and possibly eventual bankruptcy.

As a contracted resource of software and services to

pharmaceutical and other life sciences companies, we are
responsible for ensuring that our software products are compliant
with federal regulations.

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Why is Validation Needed
 Reduces risk and legal liability

 Having the evidence that computer systems are correct

for their purpose and operating properly represents a
good business practice

 Software is constantly evolving to keep up with the

increasingly complex needs of the people that use it;
therefore validation is an ongoing necessity

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Validation
 Validation is applied to many aspects of the healthcare and other regulated industries
and businesses.

 Examples include:
 Services
 Equipment
 Computer Systems
 Processes

 In each case, the objective of validation is to produce documented evidence, which

provides a high degree of assurance that all parts of the facility will consistently work
correctly when brought into use.

 Computer systems validation includes validation of both new and existing computer
systems.

Validation requires documented evidence.

If the validation process is not documented then it cannot be proved to
have occurred.

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Responsibilities
 Computer system validation must be supported at different levels
within the organization through policies, standards and
documentation

 Corporate/Business Unit
 Site/Department Personnel
 Quality Assurance and Regulatory Units
 Corporate Management
 IT Departments

Smaller companies can be considered a single Corporate/

Business Unit, but can also have different policies based
on Site [geographical] differences (e.g., USA, UK, India)

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Responsibilities & SOPs
 Each corporate [business] unit is responsible for establishing a policy
on computer systems validation requirements.

 Site or departments are responsible for:

 Computer system validation Standard Operating Procedures (SOPs)
 System inventory and assessment
 System specific validation protocols
 System specific validation documentation

 SOPs must:
 Comply with the Computer Systems Validation Policy and any Business
Unit policies that may apply
 Be approved by the appropriate management for that site or
department

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System and Inventory Assessment
 Site or departmental management is responsible for
compiling and maintaining details about their
computer systems.
 This information includes identifying the systems that
are being used and for what purposes those systems are
being used.

 The system inventory and assessment information is

used to determine which systems need to be validated.

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System Specific Validation Protocols
 Validation protocols are documents associated with
each system identified as requiring validation.

 The protocol describes the scope, procedure to be

followed, responsibilities and acceptance criteria for
the validation.

 Validation protocols should comply with the SOPs.

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Validation Documentation
 Documentation that verifies each validation activity
must be generated and stored with the validation
protocol in the appropriate archive.

 Validation documentation may include:

 test data
 summary reports
 procedures
 certification forms produced during the validation
process
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Pre-Validation Process
 Before you can validate a system, you need to identify the
systems that require validation.

 Determining if a system requires validation involves

analysis of the following areas:
 21 CFR Part 11 – electronic records and signatures
 Manufacturing processes
 Product [drug material] release or stability information
 Regulatory information
 Support GxP activities

 All users must be trained on current SOPs related to

computer system development and validation.
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System Owners
 All hardware and system/application should have a designated owner.

 Hardware Owner
 Responsible for identifying all software residing on the hardware – both system
and application software
 Maintaining the inventory whenever changes are made
 Managing the change control process for the system software and hardware
 Working with the system/application owners to determine the impact of the
change to the system/application

 System/Application Owner
 Defining the system (hardware and application)
 Completing the system assessment
 Ensuring that information pertaining to their specific system is correct and
complete
 Updating the system assessment whenever changes are made to the system
 Managing the change control process for the system/application

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Validation Master Plan
 The validation of all computer systems will be
documented in a Validation Master Plan (VMP)

 The Validation Master Plan will include:

 Identifying components requiring validation
 Prioritizing and justifying the validations to be
performed
 All activities and assigned responsibilities
 Establishing site specific procedures to support
validation
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Types of Validation
 Prospective validation – the validation of a new system
as it is developed

 Retrospective validation – the validation of an existing

system

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The Validation Process
 Consists of five specific processes
 Validation Master Plan (VMP)
 Project Plan
 Installation Qualification (IQ)
 Operational Qualification (OQ)
 Performance or Process Qualification (PQ)

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Specification and Qualification Relationships
User Requirement
PQ
Specification Verifies

Functional
OQ
Specification Verifies

Design Specification IQ
Verifies

System Build

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The Validation Process Steps
 Establish Team(s)
 These are the teams that will be responsible for the validation process

 Determine Validation Activities

 Validation activities are the exact details or activities that will be required for each of the steps in the
validation process
 The output from this activity will be the Validation Plan

 Write the Validation Protocol

 Describes the procedure and the steps within the procedure that will be followed in order to validate the
system
 The Validation Protocol must also provide a high level description of the overall philosophy, intention
and approach

 Specify the System Development Details

 Must have a good methodology in order to develop a system (SDLC)
 Must have a formal quality management system for the development, supply and maintenance of the
system

 Perform Qualification Activities

 Design, IQ, OQ, PQ

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The Validation Process Steps
 Develop/Review Controls and Procedures
 SOPs (Standard Operating Procedures)
 Training procedures and Training records

 Certify the System

 This step is where you certify that the validation deliverables have met the
acceptance criteria that were described in the Validation Protocol
 When you certify the system you should prepare a Validation Report
 The validation report should outline the details of the validation process

 Review Periodically
 The system should be reviewed periodically to provide additional assurance of
validation
 There should be documentation outlining the details of how the review is to be
done and what the review should cover
 The end result of a review should be a summary of the review and a
recommendation as to what to do next

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Software Development Lifecycle
Planning

Operations and Requirements

Maintenance Analysis

Installation, Qualifica
tion, and Design
Implementation

Integration, Test, and

Development
Validation

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 Typical SDLC SOPs
Title Phase / Description
Computer System Lifecycle Policy Overview of SDLC Process
Computer System Planning Planning
Computer System Requirements Planning / Requirements Gathering
Computer System Assessments Planning / Determining Validation Needs
Computer System Estimation Planning / Time and Resource Estimation
Computer System Design and Configuration Design / Hardware and Software

Computer System Development Build / Development, Review, and Configuration

Computer System Test Planning Testing / Planning, Strategy, Scripts, and Summary

Computer System Application Test Execution, Deviation, and

Testing / Test Execution and Deviations
Documentation Processes
Computer System Defect and Feature Management Testing / Managing Defects
Computer System Release Management Release / Release and Archiving

Computer System Configuration Management Maintenance / Change Control and Maintenance

Computer System Decommissioning Decommissioning / Retirement of Computer System

Computer System Project Closure Closure / Post Release Analysis

Computer System Maintenance and Administration Activities Maintenance / Admin and Maintenance

Computer System Change Control Maintenance / Change Control

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Resources and References
 Computer System Validation (FDA)

 21 CFR Part 11

 FDA Guidance for Industry – Computer Systems Used

in Clinical Trials

 Computer System Validation – It’s More Than Just

Testing

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