FDA/EC/WHO Expectations for Computer System Validation

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
Thank you for your time and attention!