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GxP COMPLIANCE SERVICES & SOLUTIONS

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w or
GAMP5 Introduction
lo nf
al g i
ly in

by Richard Mulders
on opy
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 co is
Richard Mulders

es n
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• Principal Consultant, Auditor & Trainer

al en
ov es
• 10+ years experience in (GxP) Computer System Validation

pr pr
– IT Systems (Manufacturing, Reporting, Control, Monitoring)

ap is
n th
– Equipment (Production, Laboratory)

rit om
w fr
– Quality Management Systems

te
ith on
• Subject Matter Expert on Computerized Systems for the Dutch

w ati
ed m
Accreditation Board (RvA)
w or
lo nf
– ISO17025
al g i
ly in

– ISO15189
on opy
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ABOUT US

co is
WORLDWIDE SERVICES & SOLUTIONS

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of ta
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Regulatory System Compliance Partners

ov es
✓ Founded in 2005 as a response to challenges

pr pr
experienced within the GxP regulated industry

ap is
✓ Privately owned company

n th
✓ Global one-stop solution provider for GxP compliance

rit om
services and software
▪ Compliance and Quality Management Software

w fr
▪ Consultancy Services, Rescop Academy, Turnkey

te
ith on
Projects

w ati
ed m
✓ Board, Corporate Management Team, Corporate QA,
w or
Global Business Development and Operations, Business
Development and Operations per area
lo nf
al g i

✓ 120 FTEs
ly in
on opy

✓ ISO 9001:2008 and ISO 27001:2013 certified

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www.rescop.com
 co is
Contact Us

es n
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R tio
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ov es
pr pr
ap is
n th
Luchthavenweg 81-41 Kwakerpad 5

rit om
w fr
5657 EA Eindhoven 4844 RP Terheijden

te
ith on
w ati
ed m
+31 (0)85 201 72 77
w or +31 (0)85 130 16 35
info@rescop.com info@qaducation.nl
lo nf
al g i

www.rescop.com www.qaducation.nl
ly in
on opy
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 co is
University / Higher Education Partners

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 C
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Introduction

al en
GXP Compliance, services & Solutions
Eurachem - GAMP 5 Introduction
15 Jul 2020
GAMP 5

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For Interactivity

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• Please open the following page on your Laptop / Phone:

rit om
w fr
te
ith on
https://pollev.com/rescop386

w ati
ed m
w or
lo nf
al g i
ly in
on opy
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 co is
Agenda

es n
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of ta
al en
• What is GAMP5?

ov es
•

pr pr
Key concepts

ap is
n th
• System Life Cycle

rit om
• Project Phase

w fr
te
ith on
• Risk management

w ati
• ed m
w or
Operational and Retirement phases
lo nf
al g i

• Summary
ly in
on opy
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 co is
Agenda

es n
p
R tio
of ta
al en
• What is GAMP5?

ov es
•

pr pr
Key concepts

ap is
n th
• System Life Cycle

rit om
• Project Phase

w fr
te
ith on
• Risk management

w ati
• ed m
w or
Operational and Retirement phases
lo nf
al g i

• Summary
ly in
on opy
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 co is
What is GAMP5?

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A computerized system is a set
EudraLex

ov es
of software and hardware

pr pr
components which together fulfill

ap is
certain functionalities.

n th
Annex 11

rit om
(2011)

w fr
The application should be

te
ith on
validated; IT infrastructure

w ati
should be qualified.
ed m
w or
lo nf
Where a computerized system replaces a manual operation, there should
al g i

be no resultant decrease in product quality, process control or quality

ly in
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assurance. There should be no increase in the overall risk of the process.

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What is GAMP5?

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The laboratory information

ov es
management system(s) used for the
ISO 17025

pr pr
(2017) collection, processing, recording,

ap is
reporting, storage or retrieval of data

n th
rit om
ISO 15189 shall be validated for functionality.
(2015)

w fr
te
ith on
“Laboratory information management

w ati
system(s)” includes the management
ed m of data and information contained in
w or
lo nf
both computerized and non-
al g i

computerized systems
ly in
on opy
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What is GAMP5?

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Aims to achieve computerized systems that are fit for intended use and

ov es
meet current regulatory requirements, by building upon existing industry good

pr pr
practice in an efficient and effective manner.

ap is
n th
rit om
Provides practical guidance that (amongst others):
• Establishes a common language and terminology

w fr
te
ith on
• Promotes a system life cycle approach based on good practice

w ati
ed m
w or
lo nf
al g i

GAMP 5
ly in

(2008)
on opy
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What is GAMP5?

es n
p
R tio
of ta
al en
EudraLex

ov es
pr pr
ISO 17025

ap is
n th
Annex 11

rit om
ISO 15189

w fr
te
ith on
w ati
ed m
w or
lo nf
al g i

GAMP 5
ly in
on opy
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 C
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https://ispe.org/

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Agenda

es n
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R tio
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al en
• What is GAMP5?

ov es
•

pr pr
Key concepts

ap is
n th
• System Life Cycle

rit om
• Project Phase

w fr
te
ith on
• Risk management

w ati
• ed m
w or
Operational and Retirement phases
lo nf
al g i

• Summary
ly in
on opy
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 C
on opy
ly in
al g i
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ed m
w ati
ith on
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te
n th
ap is
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Key concepts

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Roles and Responsibilities

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• QA – Quality Assurance

ov es
PM
QA
• PO – Process Owner (Business)

pr pr
ap is
V

n th
• SO – System Owner (IT)

rit om
• SME

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Computerized system

es n
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al en
ov es
People

pr pr
Software Procedures

ap is
n th
Hardware Data Equipment

rit om
Controlled

w fr
Computer

te
ith on
System Function &

w ati
Processes

ed m
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Computerized system
lo nf
al g i
ly in

Operating environment
on opy
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Agenda

es n
p
R tio
of ta
al en
• What is GAMP5?

ov es
•

pr pr
Key concepts

ap is
n th
• System Life Cycle

rit om
• Project Phase

w fr
te
ith on
• Risk management

w ati
• ed m
w or
Operational and Retirement phases
lo nf
al g i

• Summary
ly in
on opy
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System Life Cycle

es n
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R tio
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pr pr
Your dream
becomes reality Development Working life Retirement

ap is
n th
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on opy
ly in
System Life Cycle

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ith on
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 V - Model

C
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V - Model in System Life Cycle

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How we approach Validation?

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This picture, author: Unknown, licence: CC BY-SA

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 co is
V - Model in System Life Cycle

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GAMP Software Categories

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Category GAMP 5 Example

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IT Infrastructure – tools

ap is
layer software – OS, DB,

n th
1 Infrastructure software

rit om
Middleware

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te
ith on
2 No longer used

w ati
Firmware-based applications,
3 ed m
Non-configured Products
w or
COTS software, Instruments
lo nf
al g i

4 Configured Products ERP, EDMS, LIMS, Spreadsheets

ly in
on opy

Dedicated Applications, Custom

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5 Custom Applications GXP Compliance, services & Solutions

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 co is
GAMP Software Categories

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Category 3 Category 4 Category 5

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 co is
Agenda

es n
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R tio
of ta
al en
• What is GAMP5?

ov es
•

pr pr
Key concepts

ap is
n th
• System Life Cycle

rit om
• Project Phase

w fr
te
ith on
• Risk management

w ati
• ed m
w or
Operational and Retirement phases
lo nf
al g i

• Summary
ly in
on opy
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 C
Project Phase

on opy
ly in
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w or
ed m
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ith on
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Project Phase

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Category 3 - Non-configured Products

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Category 4 - Configured Products

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Category 5 - Custom Applications

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 co is
Agenda

es n
p
R tio
of ta
al en
• What is GAMP5?

ov es
•

pr pr
Key concepts

ap is
n th
• System Life Cycle

rit om
• Project Phase

w fr
te
ith on
• Risk management

w ati
• ed m
w or
Operational and Retirement phases
lo nf
al g i

• Summary
ly in
on opy
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ly in
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Risk Management

es n
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Data

al en
Integrity

ov es
pr pr
ap is
n th
rit om
Product

w fr
Quality

te
ith on
w ati
ed m Customer
w or
Safety
lo nf
al g i
ly in
on opy
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te
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ap is
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Why on earth do we need to do that?

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Agenda

es n
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R tio
of ta
al en
• What is GAMP5?

ov es
•

pr pr
Key concepts

ap is
n th
• System Life Cycle

rit om
• Project Phase

w fr
te
ith on
• Risk management

w ati
• ed m
w or
Operational and Retirement phases
lo nf
al g i

• Summary
ly in
on opy
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Operational and retirement phases

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 Handover  Periodic review

al en
ov es
 Establishing and managing support  Backup and restore

pr pr
services

ap is
 Business continuity management

n th
 Performance monitoring

rit om
 Security management

w fr
 Incident management

te
ith on
 System Administration

w ati
 Corrective And Preventive Action (CAPA)
ed m  Data migration
w or
lo nf
 Operational change and configuration
 System retirement,
al g i

management
ly in

decommissioning and disposal

on opy

 Repair activity
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 17025 15189

co is
Operational and retirement phases

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 Handover 7.11.5 5.10.3(b)  Periodic review 8.8 4.14.5

al en
ov es
 Establishing and managing support  Backup and restore
7.11.3(b) 5.10.3(d)

pr pr
services 7.11.3(d) 5.10.3(e)

ap is
 Business continuity management5.10.3

n th
 Performance monitoring

rit om
 Security management
7.11.3(a) 5.10.3(c/g)

w fr
 Incident management

te
5.10.3(f)

ith on
7.11.3(e)
 System Administration
7.11.3(d) 5.10.2

w ati
 Corrective And Preventive 5.10.3(f)
7.11.3(e) Action (CAPA)
ed m  Data migration 7.11.6 5.10.3(a)
w or
lo nf
 Operational change and configuration
 System retirement, 8.4.2
al g i

management 7.11.2 4.13

5.10.3(a)
ly in

decommissioning and disposal

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 Repair activity
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Agenda

es n
p
R tio
of ta
al en
• What is GAMP5?

ov es
•

pr pr
Key concepts

ap is
n th
• System Life Cycle

rit om
• Project Phase

w fr
te
ith on
• Risk management

w ati
• ed m
w or
Operational and Retirement phases
lo nf
al g i

• Summary
ly in
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Summary

es n
p
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1. GAMP is the best engineering practice Guide

ov es
pr pr
2. Validation is taking pictures

ap is
n th
3. Focus on Risk to the Patient, Product Quality and Data

rit om
Data
Integrit

Integrity y

w fr
Produ
ct

te
Qualit

ith on
y
Patient

4. Perform validation, but remember to maintain controls safety

w ati
ed m
during operational and retirement phases
w or
lo nf

5. Use GAMP5 to avoid mistakes

al g i
ly in
on opy
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Now you are ready….

of ta
al en
ov es
…. to start your GAMP5 adventure

pr pr
ap is
with computer systems validation

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GXP Compliance, services & Solutions
Eurachem - GAMP 5 Introduction
15 Jul 2020

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Richard Mulders

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Principal Consultant Rescop

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r.mulders@rescop.com

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+31 6 13138575
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GXP Compliance, services & Solutions

Eurachem - GAMP 5 Introduction
15 Jul 2020 53