ECA Certified Computer Validation Manager Course*

New Requirements for the Definition

of Electronic Raw Data

New EU GMP Annex 11 Regulations

for Computerised Systems
What will be the Impact on Your CSV Policies and
Procedures?

5 - 6 May 2011, Heidelberg, Germany

SPEAKERS: PROGRAMME:

Dr Bob McDowall „„ Identifying the Main Changes to GMP Annex 11 for

McDowall Consulting, UK Computerised Systems and GMP Chapter 4 on
Documentation
Karl-Heinz Menges „„ Scope of Annex 11: Qualify IT Infrastructure and
(European GMP Inspector) Validate Applications
Regierungspräsidium Darmstadt,
„„ Impact on Computerised System Validation
Germany
Policies and Procedures
„„ Assessing the Impact of the New Roles and Re-
sponsibilities of Annex 11
„„ Annex 11 Requirements for Electronic Signatures:
Are they the Same as for 21 CFR Part 11?
„„ Electronic Records Requirements of Chapter 4:
–– Data Integrity
–– Availability
–– Confidentiality
„„ Batch Release – Role of the Qualified Person
„„ Change Control and Configuration Management
„„ Specific Annex 11 Requirements for the Periodic
Evaluation of Computerised Systems

This education course is recognised for the ECA GMP Certification Programme „Certified Computer Validation Manager“. Please find details at www.gmp-certification.eu
New EU GMP Annex 11 Regulations for Computerised Systems
5-6 May 2011, Heidelberg, Germany

Objectives
However, it is the consequential changes to Chapter 4
that update the regulation for documentation that bring
There are three main objectives of this education course major changes to European GMP regulations. There
are new requirements for the definition of electronic
„„ To review and understand the changes that have been raw data and the need to keep and manage all elec-
made in the new version of EU GMP Annex 11 before it tronic records that brings this portion of GMP into the
becomes effective. 21st century. The new versions of Annex 11 and Chapter 4
„„ To review and understand the impact of the changes combined are Europe’s answer to 21 CFR 11 for electronic
to EU GMP Chapter 4 (Documentation) and their im- records and electronic signatures.
pact on the definition of raw data and generation and
maintenance of electronic records. Therefore individuals involved with computerised sys-
„„ To understand how the requirements of Annex 11 and tems as well as regulated organisations that operate them
Chapter 4 interact. need to be aware of the changes that these updates
bring and be prepared for them. Therefore, implemen-
These three objectives will allow organisations to plan for tation of the Annex and Chapter 4 require a good under-
the changes to policies and procedures for the validation standing of the changes and how they impact existing
of computerised systems and management of electronic computer validation policies and procedures, define and
raw data that the new regulations bring. manage electronic records but also how we validate or
revalidate computer systems in the future.
Background
This educational course is designed, through a series of
EU GMP Annex 11 for computerised systems has been an presentations, discussion and workshops, to help the un-
unchanged part of EU GMP since 1992. In 2008, the Eu- derstanding of the regulation and how to interpret it.
ropean Medicines Agency issued a proposed update
that also consisted of a Principle and 19 clauses but the Target Audience
length of text was four times as long as the current ver-
sion. This was a major change to the regulation that in- This education course should be attended by:
corporated regulatory concerns noted by inspectors with
all types of computerised systems. There were also con- „„ Quality Assurance staff, especially those involved with
sequential changes to Chapter 4 on documentation that computerised system validation
were also issued for industry comment. Within the six „„ Qualified persons
month comment period, over 1,400 responses from in- „„ System owners of computerised systems in manufac-
dustry were received by the Agency. turing, production and the analytical laboratory
„„ Computerised system validation professionals
The final version of Annex 11 was issued in January 2011 „„ CSV consultants
and becomes effective on 30th June 2011. The structure „„ IT staff either in-house, outsourcing organisations or
of the released document has a Principle and 17 clauses hosting companies
but the text is still longer than the current version it re- „„ Suppliers of GMP software applications or systems to
places. Some of the more stringent requirements from the pharmaceutical and allied industries
the 2008 draft have been removed from the final version „„ API manufacturers
of the regulation. „„ Contract research organisations with GMP operations
and contract manufacturing organisations
Major changes in Annex 11 include:

„„ Applications must be validated; IT infrastructure must Moderator

be qualified
„„ Formalisation of risk management in both computer Dr. Bob McDowall, McDowall Consulting, UK
validation and change control
„„ The life cycle validation phase has been extensively
expanded
„„ Requirements traceability throughout a life cycle
moves from a regulatory expectation to a regulatory
requirement for the first time.
„„ New requirements for data integrity, availability and
confidentiality
„„ Vendor audit reports should be available for inspec-
tors to review
„„ Explicitly allows the use of electronic signatures for
signing documents including records
Programme EU GMP Annex 11 Electronic Signatures
For the first time, the pharmaceutical organisations following
EU GMP have the authority to use electronic signatures on
Introduction to the Annex 11 Course regulatory documents, reports and records.
„„ Introduction to the teaching team „„ Annex 11 requirements for electronic signatures
„„ Overview of the two days of the course „„ Comparison of Annex 11 requirements for electronic
„„ Roadmap of the Course signatures with 21 CFR 11 - are they the same?
„„ Implementing electronic signatures to comply with
Identifying the Main Changes to GMP Annex 11 for Annex 11 and Part 11
Computerised Systems
An overview presentation looks at a brief history of Annex 11 Workshop 2:
and its revision between 2008 and 2011 and highlights the Electronic Signatures
new requirements of the regulation. The use of electronic signatures is a key component of
„„ History of Annex 11 improving productivity in the regulated quality control
„„ Structure of Annex 11 laboratory to release products faster to market. This
„„ New requirements of the regulation workshop, in the format of a facilitated discussion, will
explore what needs to be done to comply with the new
Each attendee will receive a document mapping the Annex 11 requirements for electronic signatures and if there
versions of Annex 11 that will enable them to see how will be any impact on existing validated systems validated to
the regulation has changed and where there is consist- 21 CFR 11.
ency between the original and new versions.

Inventory of Computerised Systems and System De-

Annex 11 Principles and Risk Management scriptions
The principles of Annex 11 and the new section on risk The need for an inventory of computerised systems has been
management will be discussed and compared with the old introduced into Annex 11 as well as some modifications to the
version to understand the impact of the changes in these requirements for system descriptions. This presentation will
sections. explore these two topics.
„„ Scope of Annex 11: qualify IT infrastructure and vali- „„ Inventory requirements for computerised systems
date applications „„ System description – what is required?
„„ Risk management in computer validation – has „„ Linkage with Validation Master Plans outlined in An-
anything changed in the new version? nex 15

Roles and Responsibilities in Computerised System New Requirements for Vendor Audits
Validation Annex 11 mandates that vendor audit reports should be
The new version of Annex 11 brings increased roles and available for review by inspectors, this talk will explore the
responsibilities to supplying, implementing and operating issues surrounding this area.
computerised systems „„ Identifying the changes in approach from the old to
„„ Process owners and system owners the new version of Annex 11
„„ IT Department „„ What will this mean for vendor audits in the future?
„„ Suppliers and service providers „„ Will vendor management be an undocumented requi-
rement for software suppliers that fail audits?
Workshop 1:
Assessing the Impact of the New Validation Section of GMP Chapter 4 on Documentation: What are the ma-
Annex 11 jor changes?
The new section on validation has been greatly expanded in The new version of Chapter 4 was revised in the light of the
the new version of Annex 11. Working in groups, attendees increasing use of electronic documents within the GMP
will discuss the changes and draw up a list of the major ones environment and it brings requirements for the definition of
and their impact on computerised system validation policies raw data and the handling of electronic records.
and procedures in their organisations e.g. „„ Types of records: Site Master File, instructions and
„„ Approaches for commercial versus customised records / reports
systems „„ Definition of electronic raw data
„„ What is the project life cycle? „„ Management requirements of electronic records
„„ User requirements need to be traceable throughout „„ Hybrid and electronic systems under EU GMP
the life cycle „„ Retention of documents
„„ User testing
„„ Automated testing tools
Workshop 3: Periodic Evaluation of Computerised Systems
Implementing Chapter 4 and Annex 11 Requirements The new version of Annex 11 formalises the periodic review of
for Electronic Records computerised systems and the talk will present the regulatory
The requirements for electronic records from Chapter 4 and requirements and practical interpretation of them.
the data integrity requirements of computerised systems will „„ Requirements of the new Annex 11
be evaluated in this workshop where attendees will develop „„ Practical interpretation of the new requirements – are
an approach to comply with the requirements of Chapter 4 all systems the same?
and Annex 11 in this area including archiving and data
migration.
Speakers

Data Integrity Requirements for Computerised Systems DR BOB MCDOWALL

The requirements for data integrity are split over several McDowall Consulting, Bromley, Kent, UK
clauses of Annex 11 and we will explore the updated sections Analytical chemist with over 35 years experi-
for this topic as follows: ence including 15 years working in the
„„ Accuracy checks pharmaceutical industry and 18 years work-
„„ Printouts of data ing for the industry as a consultant. He is
„„ Audit trail requirements Principal of McDowall Consulting, UK. Bob is
an ISO 17025 assessor and he has been
Regulatory Issues around the Information Technology involved with the validation of computerised systems for
Department over 20 years and is the author of a book on the valida-
In addition to the need to qualify the infrastructure there are tion of chromatography data systems. Bob is also the
several other areas that directly impact the IT department or writer of the Questions of Quality (LC-GC Europe) and
an outsourced IT service provider. Focus on Quality (Spectroscopy) columns and is a
„„ In-house or out-sourced IT – what are the require- member of the Editorial Advisory Boards of several
ments? Journals.
„„ Data storage and backup
„„ Incident management KARL-HEINZ MENGES (European GMP Inspector)
„„ Business continuity requirements Regierungspräsidium Darmstadt, Germany
Karl-Heinz Menges is an Inspector at the
Security of Networks and Computerised Systems Regierungspraesidium Darmstadt in Germa-
Security is a key requirement of computerised systems, ny. Mr Menges studied Pharmacy at the
applications and networks; here we will review the require- University of Heidelberg and received his
ments for this topic. Approbation in 1982. Mr Menges has been
„„ Security of networks and applications an Inspector for over 25 years and he is
„„ Access control requirements in the new Annex 11 currently Head of the German Inspectors Working
„„ Procedures and records for security and access control Group. He is also a member of GAMP D-A-CH steering
committee and the German delegate of the PIC/S Expert
Batch Release Circle for computerised systems. Mr Menges has also
Integrating the requirements of Chapter 4 and Annex 11, this contributed to Annex 11, PIC/S document PI 011 Recom-
presentation will focus on the role of the Qualified Person in mendations on Computerised Systems and several
releasing a batch using a computerised system in an elec- GAMP CPGs.
tronic environment.
„„ Annex 11 requirements for batch release Social Event
„„ Chapter 4 requirements for the Qualified Person
On Thursday, 5 May 2011, you are cordially invited to a social
Change Control and Configuration Management event. This is an excellent opportunity to share your experi-
Change control is an existing requirement of Annex 11; the ences with colleagues from other companies in a relaxed at-
clause has been streamlined in the new version. However the mosphere
title also mentions configuration management but does not
define the term which is confusing as there are at least two
definitions used in software engineering.
„„ Review and interpretation of the new Annex 11 requi-
rements
„„ What is configuration management?
„„ Issues in implementing the requirements
About CONCEPT HEIDELBERG ECA Education Course
Computerised Systems in Analytical Laboratories
Founded in 1978, CONCEPT HEIDELBERG is the leading organiser 2 – 4 May 2011, Heidelberg, Germany
of seminars on pharmaceutical production, quality control, qual-
ity assurance and GMP in Europe. This year more than 240 events On 2 – 4 May 2011, i.e. from Monday to Wednesday of the same
will be organised by CONCEPT HEIDELBERG. week, there will be another ECA GMP Education Course in Hei-
ECA has entrusted CONCEPT HEIDELBERG with the organisation delberg about Computerised Systems in Analytical Laboratories.
of its events. The objective of this course is
What Is ECA?
„„ to present ways of developing strategies to automate a GMP
The European Compliance Academy (ECA) is an independent analytical laboratory to reduce overall analytical turnaround
educational organisation chaired by a Scientific Advisory Board time
with members of the pharmaceutical industry and regulatory au- „„ to integrate existing or newly purchased software applica-
thorities. The ECA will provide support to the Pharmaceutical tions and leverage the business benefits of them for greater
Industry and Regulators to promote the move towards a harmo- efficiencies
nised set of GMP and regulatory guidelines by providing infor-
„„ to maintain or improve the integrity of data generated within a
mation and interpretation of new or updated guidances.
GMP analytical laboratory
What Are the Benefits of ECA? „„ to ensure compliance with GMP regulations
First benefit:
During the membership, you enjoy a € 200 discount on the reg- Topics that will be covered are:
ular participation fee of any European Conference organised by „„ Principles of the Electronic Analytical GMP Laboratory
ECA in co-operation with CONCEPT HEIDELBERG. „„ e-Compliance in Regulated Laboratories: Quality Assurance
Principles for an Electronic Analytical Laboratory
Second benefit: „„ Developing a Strategy for the Electronic Analytical Laboratory
The GMP Guideline Manager Software with a „„ What is Your Strategy for Managing the Electronic Records
large number of guidelines, e.g. EC Directives, Produced by the Laboratory
FDA Guidelines, ICH Guidelines, will be for-
„„ Involving the IT Department in Developing the Laboratory
warded to you when you are using your mem-
Strategy
bership for a conference registration.
„„ Designing Electronic Working practices and Incorporating
How Do You Become a Member of ECA? Electronic Signatures
By participating in one of the European Compliance Conferences „„ Integrating LIMS, Electronic Laboratory Notebooks and Instru-
or Courses marked with ECA, you will automatically become a ment Data Systems
member of ECA for two years – free of charge. Conferences and „„ Understanding and Applying Risk-based Computerised Sy-
Education Courses organised by ECA will be realised in co-oper- stems Validation to Laboratory Systems
ation with CONCEPT HEIDELBERG. More information about ECA „„ Users: The Human Element of the Electronic Laboratory
can be obtained on the Website http://www.gmp-compliance.
„„ Protection of Electronic Records in the Electronic Laboratory
org
„„ Quality Assurance Audit of the Electronic Laboratory
„„ Changing a System – What to Do with the Old Data?
GMP Certification Programme
„„ Facilitated Discussion: Options for Retention and Archiving of
CDS Records
This seminar is recognised within the GMP Certification Pro- „„ Streamlining Automating Computerised System Validation on
gramme. By attending selected seminars, the participant can ac-
the Electronic Laboratory
quire an additional certificate. We offer the following certification
modules: In addition, Workshops are offered about:
„„ Designing a Electronic Laboratory Strategy
„„ ECA Certified Validation Manager „„ Designing Electronic Working Practices in an Analytical GMP
„„ ECA Certified QA Manager Laboratory
„„ ECA Certified API Production Manager
„„ ECA Certified Quality Control Manager „„ Designing Integrated Systems for a Laboratory
„„ ECA Certified Technical Operations Manager „„ Designing Electronic Working Practices – the Devil is in the
„„ ECA Certified Computer Validation Manager Detail
„„ ECA Certified Regulatory Affairs Manager
„„ ECA Certified Microbiological Laboratory Manager Speakers:
„„ ECA Certified Sterile Production Manager Eberhard Kwiatkowski, Bayer Schering Pharma AG, Germany
„„ ECA Certified Biotech Manager Dr Bob McDowall, McDowall Consulting, UK
„„ ECA Certified Pharmaceutical Development Manager
The course on Computerised Systems in Analytical Laborato-
ries (2-4 May 2011) is an ideal precursor for all those who are re-
On the internet at www.gmp-compliance.org you will find a text
sponsible for laboratory systems (process owner, system owner,
explaining which seminars are recognised for which certificates.
IT department, suppliers, and service providers) to the course
Or you send an e-mail to info@gmp-compliance.org or a fax to New EU GMP Annex 11 Regulations (5-6 May 2011). Further infor-
+49-6221-84 44 64 with the request for information about the mation about the course Computerised Systems in Analytical
GMP Certification Programme. We will then send you our bro- Laboratories can be received at www.gmp-compliance.org.
chure on the topic.
Participants who register simultaneously for both courses will
receive a 350€ discount (not valid for EU GMP Inspectorates).
 Easy Registration
 Reservation Form:
CONCEPT HEIDELBERG  Reservation Form:
+ 49 6221 84 44 34 @ e-mail:
info@concept-heidelberg.de  www.gmp-compliance.org
Internet:

P.O. Box 10 17 64
69007 Heidelberg
Germany

Date

full registration fee, even if you have not made the payment yet. Only after we have received
fee will then be calculated according to the point of time at which we receive your message.

your payment, you are entitled to participate in the conference (receipt of payment will not
In case you do not appear at the event without having informed us, you will have to pay the
Thursday, 5 May 2011, 09.00 – 18.30 h
 + 49 6221 84 44 34

(Registration and coffee 08.30 – 09.00 h)

Friday, 6 May 2011, 08.30 – 16.30 h

Venue
Purchase Order No, if applicable
Crowne Plaza Hotel Heidelberg
Kurfürstenanlage 1
…… Computerised Systems in Analytical Laboratories, 2-4 May 2011, Heidelberg, Germany

Country
69115 Heidelberg, Germany
Phone + 49 / (0) 6221 917 0
Fax + 49 / (0) 6221 917 100

Fees

ECA Members € 1,490.- per delegate plus VAT

APIC Members € 1,590,- per delegate plus VAT
Department
…… New EU GMP Annex 11 Regulations for Computerised Systems

(does not include ECA membership)

Zip Code

Non-ECA Members € 1,690.- per delegate plus VAT

be confirmed)!
EU GMP Inspectorates € 845.- per delegate plus VAT
The conference fee is payable in advance after receipt of
invoice and includes conference documentation, dinner on
the first day, lunch on all days and all refreshments. VAT is
fied as soon as possible and will receive a full refund of fees paid. CONCEPT HEIDELBERG will
not be responsible for discount airfare penalties or other costs incurred due to a cancellation.

reclaimable.
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Reservation Form (Please complete in full)

If you register for the ECA Education Course “Computer-

ised Systems in Analytical Laboratories” from 2 to 4 May
5-6 May 2011, Heidelberg, Germany

2011 at the same time, you will receive a 350 EUR discount.
This is not valid for EU GMP Inspectorates.

Accommodation

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Ms.

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The official conference language will be English.

Organisation and Contact

CONCEPT HEIDELBERG
1. We are happy to welcome a substitute colleague at any time.

P.O. Box 10 17 64
If you cannot attend the conference you have two options:

D-69007 Heidelberg, Germany

Fax +49 (0) 62 21/84 44 34
CONCEPT HEIDELBERG

Phone +49 (0) 62 21/84 44-0, Fax +49 (0) 62 21/84 44 34

D-69007 Heidelberg

info@concept-heidelberg.de,
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#

wa/vers1/19012011