who said training in computerized systems validation is boring?

DOI: 10.1002/qaj.326

Who Said Training in ComputerizedSystems Validation is Boring?

Marc Brooks1 and Kjeld Wetlesen2,*1 ALTANA Pharma AG, Clinical Operations, Byk-Gulden-Str. 2, 78467 Konstanz, Germany2 tpi consulting gmbh, Ermitagestrasse 17, 4144 Arlesheim, Switzerland

Summary

This case study describes how ALTANA Pharma provides modular and role-basedtraining in computerized systems validation. The training is fun while providing allnecessary information with hands-on experience. This is achieved by using manydifferent kinds of exercises to support the learning experience of the presentations ina creative way. Copyright # 2005 John Wiley & Sons, Ltd.

Key Words: computerized systems validation; training; GAMP

Introduction

Training in computerized systems validation

(CSV) is mandatory for companies using in-

formation technology (IT) systems in good

clinical practice (GCP), good laboratory practice

(GLP) and good manufacturing practice (GMP),

i.e. GXP, regulated processes. That’s a fact.

Recipients of traditional CSV training will

often describe the experience as tedious and

boring. This article describes innovative solu-

tions adopted by ALTANA Pharma to provide

CVS training that participants find engaging,

creative and fun!

Everybody agrees that training in CSV is an

important topic. Not only because authorities

require evidence that you have qualified people,

but also because of sound business principles.

CSV is all about how you can ensure that your

computer systems are consistently performing as

specified and that you are in control of your

data.

To achieve these objectives, CSV training has

to convey information about the chosen Soft-

ware Development Lifecycle, e.g. deliverables

from a normal waterfall-model [1,2].

You also have to deliver information on your

company’s interpretation of the US Food and

Drug Administration’s (FDA) requirements for

Validation Documentation [3,4]. Often the

interpretation is influenced by external sources

like good automated manufacturing practice

(GAMP 4) [5] (Figure 1-next page).

And if that is not enough to break the neck on

the course participants, you will also have to

give your company’s interpretation of rules,

regulations and guidances such as:

* 21 Code of Federal Regulations (CFR) Part

11 [3];* FDA’s Guidance for Industry: Computerized

Systems Used in Clinical Trials [4];* GAMP 4 [5];* Pharmaceutical Inspection Convention

Scheme (PIC/S) Guidance on Good Practices

for Computerized Systems in Regulated

‘GXP’ Environments [6];* European Union (EU) GMP Annex 11 –

Computerized Systems [7];* IT Infrastructure Library (ITIL) [8,9];* . . .and a lot more [10,11].

*Correspondence to: Kjeld Wetlesen, tpi consultinggmbh, Ermitagestrasse 17, 4144 Arlesheim, Switzerland.E-mail: [email protected]

Copyright r 2005 John Wiley & Sons, Ltd. Qual Assur J 2005; 9, 85–94.

The above list of topics to be covered in the CSV

training is not exhaustive but merely stated here

to illustrate the fact that there is a lot of ground

to cover in the CSV training and it is basically

very ‘dry’ information.

Everyone trying to prepare the course material

for a CSV training course will encounter this

problem; and it was also faced by ALTANA

Pharma when the need for an ALTANA-specific

CSV training program became apparent.

This article describes how ALTANA Pharma

coped with this challenge and actually devel-

oped a CSV training program, which is currently

being delivered to the organization by web-

seminars and regional conferences. Feedback

from the training participants is encouraging

and they consider the training course to be

interesting, inspiring and a lot of fun!

Training Plan

Preparation of project plan

The first thing to do in any project is to prepare

a project plan. Preparing a training package is

no exception and, therefore, the first step in the

ALTANA Pharma case was to prepare a training

concept and get the buy-in from management.

In the training concept, the objective for the

CSV training was based on the approved

validation policies. Sound business principles

are the basic enablers for launching the whole

endeavour and management support from the

very beginning is mandatory.

Definition of roles

Depending on the exposure and responsibilities

with regard to computerized systems, the level

of CSV knowledge varies considerably among

staff members. To account for the different

levels of expertise among the course partici-

pants, the following roles were defined:

1. Application System Owner;

2. Infrastructure System Owner;

3. Project Manager;

4. System Engineer/System Administrator;

5. Software Developer;

6. Facility Owner;

7. IT Validation Manager;

8. IT Validation Coordinator;

9. Independent Quality Assurance (QA).

A training profile was defined for each role

based on the relationship to CSV.

Definition of course modules

The next section in the Training Plan defined the

course modules. As a reference for the module

definition the V-model was used, which is a

different representation of the waterfall model.

The following modules were defined:

Figure 1. Some examples of deliveries in a CSV package

86 M Brooks and K Wetlesen


1. Introduction to CSV;

2. Validation Compliance;

3. Project Management;

4. Development and Testing;

5. On-going Operations and IT Service Manage-

ment;

6. QA.

Figure 2 illustrates the mapping between the

course modules and the V-model:

Module 1: Introduction to CSVThis module is intended to give a very general

introduction to CSV in the form of a Web

Seminar. The objective is to explain why CSV is

needed, to inform about the basic requirements

and to illustrate the consequences of non-

compliance by some real-life examples. Further-

more, this module shows how the remaining five

CSV modules cover the learning objectives.

Module 2: Validation ComplianceThis module goes into more detail with the

current regulations and guidelines related to

CSV (see Figure 3). It provides the ALTANA

Pharma specific interpretations as documented

in the ALTANA Pharma global policies and

guidelines. Furthermore, the process flow of the

compliance program with its various assess-

ments is covered, for example 21 CFR Part 11

assessment.

Module 3: Project ManagementThe Project Management module focuses on the

Validation Plan and the content of a Validation

Plan at ALTANA Pharma.

Figure 2. CSV course modules mapped with the V-model. URS: user requirement specifica-tion, FS: functional specification, DS: design specification, IQ: installation qualification, OQ:operational qualification, PQ: performance qualification, SLA: service level agreement

Training in Computerized Systems 87


One of the fundamentals in CSV is to ensure a

clear definition of the intended use of the system.

This is achieved by a formal User Requirements

Specification (URS) as described in the Project

Management module.

Risk Assessment, which is one of the new

topics of discussion within the validation com-

munity, is also covered since the outcome of the

risk assessment impacts the content of the

Validation Plan (see Figure 4).

The Validation Report is also covered in this

course module because of the 1:1 mapping with

the Validation Plan (see Figure 2).

Furthermore, Supplier Evaluation and Risk

Assessment are covered in this module as well.

Module 4: Development and TestingThe entire lifecycle of implementation and

verification of the approved URS is covered in

the ‘Development and Testing’ course module.

At ALTANA Pharma, the Software Lifecycle

is very much aligned with GAMP 4; and the

‘Development and Testing’ module, therefore,

addresses project deliverables like Functional

Specification (FS), Design Specification (DS),

Coding, Test and Qualification.

Module 5: On-going Operations and ITService ManagementIt is not sufficient to have a well-functioning

software system in order to meet the CSV

requirements. Your system has a much broader

scope than just the software.

Module 5 covers the set of procedures to

support the operation during normal as well

as extraordinary situations, security, service

level agreements (SLAs) and the final decom-

missioning.

Module 6: QAThe final module in the CSV training modules is

‘QA’, explaining the role of the QA function in

relation to a validation project (see Figure 5).

The module outlines QA responsibilities such

as the review of deliverables from the Validation

Report, but also covers the need to conduct

vendor audits and provides guidance on the

timing, scope and approach of such audits.

Development of Training Matrix

The CSV course modules are not ‘one size fits

all’. The relevance of the course modules

depends on the individual’s specific role and

responsibilities in an actual validation project.

If your role is the Application System Owner,

you need to participate in awareness/overview

training. This is covered in a 1–2-h ‘Introduction

to CSV’ Web Seminar. As IT Validation Man-

ager, however, you will need to attend the entire

suite of course modules.

Figure 3. Slide from Module 2 – ‘ValidationCompliance’. EMEA: European MedicinesAgency, MHLW: Japan Ministry of Health,Labor and Welfare

Figure 4. Slide from Module 3 – ‘ProjectManagement’



To provide clarity on the required training

modules, the Training Plan maps the defined

roles with the course modules in a ‘Training

Matrix’ (see Table 1).

Finally, classroom training was implemented

and is offered worldwide. One entire training

course takes 4 days and covers Introduction to

CSV, Project Management, Validation Compli-

ance program, Development and Testing and

Ongoing Operations. Project Managers and QA

staff members participate in all course modules,

whereas and developers and administrators join

Figure 5. Slide from Module 6 – ‘QA’

Table 1. Training matrix

Module 1 Module 2 Module 3 Module 4 Module 5 Module 6

Roles Introduction toCSV

ProjectManagement

Developmentand Testing

OngoingOperations

IT QA ValidationComplianceprogram

IT ValidationCoordinator

� – – – – –

System Owner/Application Owner

� – – – – –

Project Manager � � � � – �IT ValidationManager

� � � � – �

InfrastructureSystem Owner

� – – – – –

System Engineer/Administrator

� – � � – –

SoftwareDeveloper

� – � � – –

Facility Owner � – – – – –Independent QA � � � � � �



the training for the last 2 days. Additionally, the

Introduction to CSV and IT QA modules are

trained as needed.

The advantage of the modular concept is that

employees who have to attend multiple modules

can take part at times that fit in with their work

schedule, for example Project Management and

Validation Compliance program in January and

Development and Testing and Ongoing Opera-

tions in March.

How Can You Avoid Boring CSVTraining?

In the ALTANA Pharma CSV Training Package,

we have turned a topic that is often described as

‘dry and boring’ into one that is ‘engaging and

fun’ by applying innovative and creative solu-

tions.

Animations

You have probably already noticed that the

examples from the CSV Training Package shown

in the figures above make use of pictures and

graphs. The idea is to keep the audience awake

by teasing them with some funny animated clips.

Pictures can say more than a 1000 words.

Discussions

Active participation from the course attendees is

crucial. The CSV Training Package makes use of

many tools to encourage active participation, for

example, pre-planned discussion scripts to kick

off discussions that the instructor wants to

incorporate during the courses. CSV is particu-

larly well suited to classroom discussions,

because basically, it is grounded on common

sense.

Figure 6 illustrates an example of a discussion

script:

Quizzes

The human being loves competitions. They love

to watch and, even better, to participate and

win! The ALTANA Pharma CSV Training

Package therefore contains several quizzes to

inspire the learning process.

One of the competition forms used is known

from the TV show ‘Jeopardy’. The instructor

provides the answer to a question and the course

participants have to formulate the question that

fits the answer (see Figure 7).

Another form is ‘puzzle’. You receive the

V-model totally mixed up. The exercise is to

bring it into order.

LEGOTM

CSV is basically a workflow with a long list of

interdependent deliverables. To illustrate the

Figure 6. Example of a planned discussion inModule 4 – ‘On-going Operations and ITService Management’

Figure 7. An example of a planned quiz in‘Validation Compliance’ course module



concept of CSV, it is therefore helpful to create

an exercise that mirrors the workflow of

producing the CSV deliverables.

In the ALTANA Pharma case, the initial idea

for such an exercise was to simulate the basic

development and validation activities with an

example from IT. This was supplemented with a

request for adding change requests and config-

uration management activities to the exercise in

order to illustrate the real life situation of an IT

system that undergoes changes during its life

cycle.

However, ALTANA Pharma requested that no

group of employees, based on their technical

background, should be favoured nor disfa-

voured during the exercises.

To fulfil this request, the idea of using an IT

development project as exercise was turned

down and the idea of using LEGOTM emerged.

The beauty of using LEGOTM is that everybody

can contribute, since the required basic devel-

opment skills are learned literally from child-

hood.

The ideal LEGOTM model must have the

‘right’ level of complexity: It must con-

tain enough details to enable diversities;

Figure 8. Santa Claus: ‘Business needs’ (left)and the final construction (right) – find fiveerrors!

Figure 9. Working with the LEGOTM exercise



however, it must not be more complex than

a participant is able to produce a description,

build the model and test it within a limited

time frame. With these constraints, some

simple LEGOTM models were chosen. The Santa

Claus illustrated in Figure 8 shows one of the

models used.

In the ALTANA Pharma CSV training,

the LEGOTM exercises covered the following

activities:

* Planning Validation;* Creating an URS;* Creating an FS;* Planning a Test;* Constructing a model based on the URS;* Testing (Operational Qualification/Perfor-

mance Qualification) the model;* Creating a Validation Report;* Create a Configuration log;

* Create a Change Request;* Update the Configuration Log.

The LEGOTM exercise is not only a lot of fun

and generates active participation (see Figure 9)

but also reveals a lot of surprising lessons to

learn as the LEGOTM exercises move on.

Different teams perform the different stages in

the exercises. One lesson learned is that if a

certain stage in the exercise is not done well, the

subsequent teams will encounter problems and

the following stages will suffer.

One example is the importance of a good

URS. If the URS is insufficient, you will never be

able to make a LEGOTM construction which is

meeting the business needs, i.e. the construction

on the LEGOTM model above. To give you an

idea how a verbal LEGOTM URS looks like, let

us have a look at Figure 10.

Figure 10. An example of URS for the LEGOTM exercise



Tests

Today it is no longer considered ‘Best Practices’

just to document the attendance to training.

There is an increasing tendency to require

evidence that each individual course participant

has understood the content of the training

program.

To accomplish this, each training module of

the ALTANA CSV Training Package includes a

multiple-choice test to be conducted at the

termination of each module (with the exception

of ‘Introduction to CSV’).

Figure 11 is a snapshot of a part of the test

related in the Course Module 3 ‘Development

and Testing’.

Conclusion

The ALTANA CSV Training Package is finalized

and the international delivery of the training

started in the autumn 2004. The feedback is

extremely positive and the students involve

themselves quite intensively in the classroom

training.

The Training Package is customized for

ALTANA Pharma and contains company-speci-

fic components, e.g. ALTANA Pharma Standard

Operating Procedures. However, the concept

and scope of the Training Package can be

applied to any company that must adhere to

FDA regulations.

This case study shows that training in CSV

does not have to be boring.

References

1. ISO 90003:2004, Software engineering – Guidelines

for the application of ISO 9001:2000 to computer

software. Available at http://www.iso.org

2. ISO 12207:1995, Information Technology – Software

Life Cycle Processes. Available at http://www.iso.org

Figure 11. An example of a planned test in Module 3 – ‘Development and Testing’



3. 21 CFR Part 11, Electronic Records; Electronic Signa-

tures. Available at http://www.fda.gov/oc/gcp/regula-

tions.html

4. FDA: Guidance for Industry: Computerized systems

used in Clinical Trials, April 1999. Available at http://

www.fda.gov/ora/compliance ref/bimo/ffinalcct.pdf

5. The Good Automated Manufacturing Practice

(GAMP4) Guide for Validation of Automated Systems

in Pharmaceutical Manufacture. December 2001.

Information on GAMP4 available at http://www.is-

pe.org/gamp

6. PIC/S Guidance on Good Practices for Computerised

Systems in Regulated ‘GXP’ Environments. PI011-2, 1

July 2004. Available at http://www.picscheme.org

7. EU GMP Annex 11 – Computerised Systems. Available

at http://pharmacos.eudra.org/F2/eudralex/vol-4/pdfs-

en/anx11en.pdf

8. ITIL (IT Infrastructure Library). Available at http://

www.ogc.gov.uk

9. British Standards Institution’s Standard for IT Service

Management (BS15000). Available at http://bsonli-

ne.techindex.co.uk

10. Stokes T. The Survive and Thrive Guide to Computer

Validation. Interpharm Press, Inc.: 1998. Available at

http://www.gxpinternational.com/gxpinternational.

htm

11. ISO 9001:2000, Quality management systems –

Requirements. Available at http://www.iso.org



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