Computer System Validation

Embedding quality into

Automated Processes

Validation definition
Establishing
Establishing documented evidence
which provides a high degree of
assurance that a specific
p
process
p
will
consistently produce a product meeting
its pre-determined specifications and
quality
lit attributes.
tt ib t
FDA definition 1987

Validation
1.
2.
3.
4.
5.

Documented evidence
g degree
g
of assurance
high
specific process
consistently produce
pre-determined specifications

Required
q
by
y Legislators
g
Compulsory Good Practices
(i.e. imposed Quality System)
The GxPs

Laboratories GLP
Clinical Studies GCP
Manufacturing GMP

Regulatory Topology & trends

Understand the System

y
What is the system
What does the system consist of
What does it do for whom

Understand the system

Production as a system

W.E. Deming - Out of the Crisis

Page 4

Validation
1.
2.
3.
4.
5.

Documented evidence
g degree
g
of assurance
high
specific process
consistently produce
pre-determined specifications

General validation activities

planning

specification
test planning
IQ
OQ
PQ
Q
testing
IQ
OQ
PQ

review and report

Prepare
p
written Validation p
plan

Specify and agree what is required

(what does the system do for whom)

Write document to describe what is

to be verified

Perform test and collect results

Review and report conclusions

Validation Pathway
Validation Plan

(1)

Validation Report
PQ

URS

OQ

Func. Specs.
Tech. Specs.

IQ

H/W S/W

Modules &

Design
Specs.

Integration Test

Source
Code

User Requirements Specification

Purpose
- Documents what the user wants the system to do
- Contract between Customer and Vendor
- Sets project scope
- Foundation
F
d ti for
f remainder
i d off project
j t plan
l
- Basis for PQ testset
Validating a system without URS is impossible

15 februari 2008

16

About the Vendor

E t bli h sound
Establish
d relationship
l ti
hi
- E
E-data
data is a corporate asset
- Business cannot survive without sound
vendor support
pp
- Vendor can partly qualify the system
(IQ/OQ)

Customer & Vendor

Who does What ?

Source
Code

Customer & Vendor

Customer

Vendor

Source
Code

System
y
from Vendor
Functional
Validation

Structural
St
t
l
Validation
Source
Code

~ 65% of IT Projects not fully successful

The Standish Group: CHAOS Report 2006
Copyright 2003, ITC Validation Consultants

How Come ?

Fundamental design errors end here

Copyright 2003, ITC Validation Consultants

Building process for IT systems

Development phases

Project cost for standard IT system

10 %

Datasource: Accenture

20 %

20 %

35 %

15 %

Cost aspects
!

Cost of Non Quality

- correcting errors

1x

3x

~ 15

Datasource: Pharmaceutical Education and Research Institute

~ 45

~ 200

Potential cost of non quality

~ 400

Integrated Systems cause cost explosion

~ 90
2x
1x

6x
3x

~ 30
~ 15

~ 45

~ 200

It takes Time and Planning to

understand the system
y

Production as a system

W.E. Deming - Out of the Crisis

Page 4

Ab t nott planning..
About
l
i
The best thing about doing no planning is that failure comes as a
complete surprise, and is not preceded by a period of worry,
depression and panic.
Sir John Harvey-Jones

28

Take Home
Understand the business as a system
(Hospital, Laboratory, Production Plant)
Understand the underpinning processes
Understand what needs to be automated
and why (build URS)
Write Business Case