This document discusses expectations for validation of computer systems according to FDA/EC/WHO guidelines. It defines validation as establishing documented evidence that a process will consistently produce products meeting predetermined specifications. For software validation, it means establishing evidence that software conforms to user needs and intended functions. The document outlines key aspects of software validation including requirements analysis, design, testing, integration and maintenance. It provides examples of validation for different types of software like off-the-shelf, custom designed, in-house developed and maintained software. Important elements of an effective validation program include training, procedures, documentation and communication between developers and quality assurance.

1. FDA/EC/ WHO
Expectations for Validation
of Computer Systems
FDA/EC/ WHOFDA/EC/ WHO
Expectations for ValidationExpectations for Validation
of Computer Systemsof Computer Systems
M. LuqmanM. Luqman
Assistant Manager ValidationAssistant Manager Validation

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Validation
• 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.

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Validation
• Must have knowledge that the
process used to make the product, be
it software or hardware, is going to
produce a product that is consistent
from lot to lot, unit to unit.

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Software Validation
• Establishing by objective evidence
that the software conforms with
user needs and intended uses of
those functions that have been
allocated to the software.

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Software Verification
• Confirmation that the output of a
particular phase of development meets all
of the input requirements for that phase
• Verification Activities
– Testing
– Walk throughs
– Code and document inspection

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Life Cycle Activities
• Risk Management/Hazard Analysis
• Requirements Analysis and Specification
• Design
• Implementation
• Integration
• Validation
• Maintenance

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D e f i n e s y s t e m
F u n c t i o n S t r u c t u r e
D e f i n e s y s t e m
F u n c t i o n S t r u c t u r e
D e f i n e S o f t w a r e
D e s i g n / S p e c i f y
h a r d w a r e
D e v e l o p
S o f t w a r e
V e r i f y S o f t w a r e
T e s t I n d i v i d u a l
M o d u l e s ( C o m p u t e r
S y s t e m )
I n t e g r a t e
C o m p u t e r i z e d S y s t e m
T e s t I n t e g r a t e d
m o d u l e s
( C o m p u t e r i z e d
S y s t e m )
D e m o n s t r a t e t o t a l
s y s t e m o p e r a t i o n
( C o m p u t e r - R e l a t e d
S y s t e m )
C h a n g e
Q u a l i f y S y s t e m
R e v i e w o p e r a t i n g
e x p e r i e n c e
D a t a
C o n d u c t s y s t e m
t e s t i n g ( i f n e e d e d )
D a t a a n a l y s i s
V a l i d a t i o n
A c c e p t a n c e
O n g o i n g s y s t e m e v a l u a t i o n
N e w C o m p u t e r S y s t e m E x i s t i n g C o m p u t e r S y s t e m
I n s t a l l h a r d w a r e
Q u a l i f y h a r d w a r e
F i l e D o c u m e n t a t i o n

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FDA / WHO / EC Inspection
• What documentation do you have for
the software?
– Requirement Specifications
– Design
– Test plans and results
– Validation Plans and Reports
– Hazard Analysis
– Criticality Analysis

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Requirement
Specifications
• Complete
• Correct
• Consistent
• Current
• Verifiable
• Traceable
• Unambiguous

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Design
• High Level
Diagrams
• Interface
definition
• Critical decision
points
• Hazard Analysis
• Reports Design

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Test Plans and Results
• Matrix to map to Requirements
• Specific so that they are repeatable
• Test thoroughness based on criticality
or hazard analysis
• Expected results stated
• Complete reporting of actual results
• Reviewed and signed off

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Validation Plans and
Reports
• Review of all documentation
• Any deviations reviewed and categorized
• Critical areas are fixed
• Minor areas, SOPs put in place
• User manual complete and correct
• Signed off as released

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Important Elements of
Validation Program:
• Training of personnel on software validation
and guidelines on what software products
have to be validated.
• Defined internal procedures for conducting
the validation program, including standards
for writing specifications, guidelines for
validating process software, and forms for
identifying and tracking safety hazards.

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Important Elements of
Validation Program:
• Training/requiring programmers to retain their
testing documentation.
• Allocation of resources to conduct the
validation program
• Development of a validation program that
focus resources on critical areas.
• Use of documentation templates, measurement
tools and checklists where appropriate

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Important Elements of
Validation Program:
• Communication between programmers
and the QA/QC personnel and QA/QC
functions that contribute to the
development efforts.
• Application of software validation and
QA/QC techniques early in the
software development process.

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Software Scenarios
• Off-The-Shelf Software
• Custom Designed Software
• Developed In-House
• Maintained Software

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Off-The-Shelf Software
• Word processing
• Spreadsheet / Database
• Information Management

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Off-The-Shelf Software
• Word processing
– Meets Requirements

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Off-The-Shelf Software
• Spreadsheet / Database
– Meets Requirements
– Key Functions perform properly
– Validation of created Formulas, Scripts,
and Routines

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Off-The-Shelf Software
• Information Management
– Meets Requirements
– Hardware installed properly
– Key Functions perform properly
– Integration between software and
hardware

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Custom Designed
• Requirement Specification
• Key Functions perform properly
• Software Development Documents
and Validation done by Vendor

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Written In-House
• Complete Software Development
Documentation
• Validation

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Maintained Software
• Software Development
Documentation for changes to
software
• Validation of Changes
• Integration to rest of software
program.

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•Questions
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