SAP Validation and GMP Compliance

Size: px

Start display at page:

Download "SAP Validation and GMP Compliance"

Arlene Reynolds
6 years ago
Views:

SAP Validation and GMP Compliance Live demonstration: Using SAP Solution Manager as a Validation platform Get a set of useful templates for download SAP S/4 HANA SPEAKERS: Thomas Brandacher PWC

Herterich and Consultants LEARNING OBJECTIVES: Validation Validation strategies What needs to be validated? Process oriented vs.

1 SAP Validation and GMP Compliance Live demonstration: Using SAP Solution Manager as a Validation platform Get a set of useful templates for download SAP S/4 HANA SPEAKERS: Thomas Brandacher PWC Consulting Lasse Janz Dräger Florian Rauch DHC Dr. Herterich and Consultants 6-7 November 2018, Berlin, Germany Stefan Staub DHC Dr. Herterich and Consultants Stefan Temps DHC Dr. Herterich and Consultants LEARNING OBJECTIVES: Validation Validation strategies What needs to be validated? Process oriented vs. transaction oriented Global versus local Best practice approach Agile vs. V-Model Operation Change management Lifecycle management Periodic evaluation Data Migration Audit trail in SAP Data Integrity and SAP SAP S/4 HANA in a GxP environment This education course is recognised for the ECA GMP Certification Programme Certified Computer Validation Manager. Please find details at

2 SAP Validation and GMP Compliance 6-7 November 2018, Berlin, Germany Objectives You will learn How to validate SAP in a GMP environment Which specific requirements should be taken into consideration in the CSV process How to use SAP Solution Manager as a validation platform What problems could arise during validation and how to solve them How to maintain the validated state of SAP with the least efforts Background The leading Enterprise Resource Planning (ERP) System in industry is SAP. Meanwhile it has also become the standard solution for pharmaceutical companies. As the system is used for GMP critical operations (e.g. inventory, master data management, batch release) validation is a must and a critical element of the SAP implementation. Controlled operations, including Change Control will ensure the validated state is maintained. This ECA course will offer you shared best practices for the validation of SAP considering recent regulatory requirements like EU GMP Guide Annex 11, GAMP 5 and 21 CFR Part 11. Programme Introduction SAP Validation Legal requirements Process oriented vs. transaction oriented validation Best practice approach Agile vs. V-Model SAP Configuration Management vs. Validation Approach Implementation Approach Customizing and Developments Change and Transport System Enhancement Packages and Business Functions System landscape of SAP Pharma process landscape What is needed and what needs to be validated (high level risk assessment) Introducing the SAP modules Standard risk assessment for each module Live demo Using SAP Solution Manager as a Validation platform Project Tool in a regulated environment Document management Test management Document status report Support Tool Incident management Integrative change management Target Group This Education Course is directed at experienced employees from IT & IT Service Providers Quality Assurance / Quality Control Production / Engineering who have to deal with SAP in a healthcare environment. Templates All participants get a set of useful templates for download Validation plan User requirement specifications Functional specifications Test scripts Risk assessment questions SOPs for operating the validated system Data migration Special features of SAP HANA SAP S/4 Hana innovation highlights Transformation scenarios to SAP S/4 HANA Challenges for the validation approach Validation of S/4 HANA as cloud deployment Process harmonisation and standardisation using a template strategy / SAP and GMP Compliance Functional gaps Process driven system functionality Compliance driven system functionality Managing a global SAP program in a validated environment Governance and global framework Vendor selection & staffing (including offshoring) Ramp up and training Documentation approach Milestones & key deliverables Toll gate reviews Data migration approach SOX in a project Handover to support Including templates and selected guidelines.

Data Migration A strategic approach to data migration Regulatory requirements and data migration Validating the data migration Data Integrity and SAP Regulatory requirements (FDA, EU, MHRA) Critical

3 Data Migration A strategic approach to data migration Regulatory requirements and data migration Validating the data migration Data Integrity and SAP Regulatory requirements (FDA, EU, MHRA) Critical processes (QC) Roles and responsibilities SAP support tools (MDG) Audit trail in SAP Compliance for audit trails: definitions and requirements A risk-based approach to audit trails Implementing audit trails Audit trail reviews Processes and experiences with validation of SAP within a regulatory context Change management; IT Validation and electronic record keeping for quality relevant process software as a manufacturer of medical devices How to ensure that quality relevant impacts are evaluated when changing a validated SAP system? How to ensure that efforts for validation are kept on an efficient level without compromising quality and regulatory requirements? How to effectively link system, process and validation documentation? How to manage electronic records within SAP? GMP compliance for SAP authorisation User and authorisation management Documentation approach for authorisation Testing of authorisation requirements Social Event In the evening of the first course day, you are cordially invited to a social event. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere. Speakers Thomas Brandacher PWC Consulting LLC, Tokyo, Japan Thomas Brandacher was Head Global ERP Project Management Office (PMO) at the Sandoz site in Holzkirchen close to Munich. Within Sandoz and other companies he managed SAP projects over a period of more than 10 years. He joined PWC Consulting as Managing Director in Lasse Janz Drägerwerk AG & Co. KGaA, Germany Lasse Janz studied Business Informatics at Kiel University of Applied Science. Since 2015 he is a Quality Manager at Drägerwerk AG & Co. KGaA (Software Validation Officer, Global Process Owner Software Validation and Global Process Owner Electronic Signature). Florian Rauch DHC Dr. Herterich & Consultants GmbH, Germany Florian Rauch joined DHC Dr. Herterich & Consultants as a Consultant in During the last years he worked in multiple SAP Solution Manager implementation and SAP authorization projects in medical devices industry. Florian studied Computer Science at the University of Applied Sciences in Schmalkalden (Germany). Stefan Staub DHC Dr. Herterich & Consultants AG, Switzerland Stefan Staub joined DHC Dr. Herterich & Consultants AG as a Consultant in He is a specialist in Computerized System Validation with a strong focus on large SAP ERP implementation projects. Since 2012 he is part of the DHC AG management team. Prior joining DHC AG Stefan studied Business Administration with an emphasis on Information and Technology Management at the University of St. Gallen (Switzerland). Stefan Temps DHC Dr. Herterich & Consultants AG, Switzerland Stefan Temps joined DHC Dr. Herterich & Consultants as a Senior Consultant in Since 2000 he is Managing Director of DHC AG, Switzerland. During the last years he was engaged as project manager for SAP ERP implementation projects and GxP compliance in the pharmaceutical industry. Prior to joining DHC in 1996, Stefan studied Industrial Engineering and Management at the Technical University of Hamburg (Germany).

4 F F Easy Registration Reservation Form: CONCEPT HEIDELBERG P.O. Box Heidelberg, Germany Reservation Form: info@concept-heidelberg.de Internet: Reservation Form (Please complete in full) If the bill-to-address deviates from the specifications on the right, please fill out here: F SAP Validation and GMP Compliance, 6-7 November 2018, Berlin, Germany F Virtual IT Systems in a GxP Environment, 8-9 November 2018, Berlin, Germany * Mr * Ms Title, first name, surname Company Department Important: Please indicate your company s VAT ID Number P.O. Number (if applicable) Street/P.O. Box City Zip Code Country CONCEPT HEIDELBERG P.O. Box Fax +49 (0) 62 21/ Phone/Fax D Heidelberg GERMANY (please fill in) # Privacy Policy: By registering for this event, I accept the processing of my Personal Data. Concept Heidelberg will use my data for the processing of this order, for which I hereby declare to agree that my personal data is stored and processed. Concept Heidelberg will only send me information in relation with this order or similar ones. My personal data will not be disclosed to third parties (see also the privacy policy at I note that I can ask for the modification, correction or deletion of my data at any time via the contact form on this website. you have to inform us in writing. The cancellation fee will then be calculated according to the point of time at which we receive your message. In case you do not appear at the event without having informed us, you will have to pay the full registration fee, even if you have not made the payment yet. Only after we have received your payment, you are entitled to participate in the conference (receipt of payment will not be confirmed)! (As of January 2012) German law shall apply. Court of jurisdiction is Heidelberg. General terms and conditions If you cannot attend the conference you have two options: 1. We are happy to welcome a substitute colleague at any time. 2. If you have to cancel entirely we must charge the following processing fees: Cancellation - until 2 weeks prior to the conference 10 %, - until 1 weeks prior to the conference 50 % - within 1 week prior to the conference 100 %. CONCEPT HEIDELBERG reserves the right to change the materials, instructors, or speakers without notice or to cancel an event. If the event must be cancelled, registrants will be notified 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. Terms of payment: Payable without deductions within 10 days after receipt of invoice. Important: This is a binding registration and above fees are due in case of cancellation or non-appearance. If you cannot take part, Date Tuesday, 6 November 2018, h h (Registration and coffee h h) Wednesday, 7 November 2018, h h Venue Steigenberger Hotel Berlin Los-Angeles-Platz Berlin, Germany Phone +49(0) berlin@steigenberger.de Fees (per delegate plus VAT) ECA Members 1,490 APIC Members 1,590 Non-ECA Members 1,690 EU GMP Inspectorates 845 The conference fee is payable in advance after receipt of invoice and includes conference documentation, dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable. Accommodation CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotels. You will receive a room reservation form when you have registered for the event. Reservation should be made directly with the hotel. Early reservation is recommended. Would you like to save money? If you book SAP Validation and GMP Compliance and Virtual IT Systems in a GxP Environment (8-9 November 2018) simultaneously the fee reduces as follows: ECA Members 2,790 APIC Members 2,890 Non-ECA Members 2,990 EU GMP Inspectorates 1,690 Conference Language The official conference language will be English. Organisation and Contact ECA has entrusted Concept Heidelberg with the organisation of this event. CONCEPT HEIDELBERG, P.O. Box Heidelberg, Germany Phone +49-(0)62 21/ Fax +49-(0)62 21/ info@concept-heidelberg.de For questions regarding content: Dr Andreas Mangel (Operations Director) at +49(0) / or at mangel@concept-heidelberg.de. For questions regarding reservation, hotel, organisation etc.: Mr Rouwen Schopka (Organisation Manager) at +49(0) / or per at schopka@concept-heidelberg.de. WA/

5 Virtual IT Systems in a GxP Environment SPEAKERS: Bob McDowall R.D.McDowall Limited Yves Samson Kereon AG Jürgen Schmitz GSK 8-9 November 2018, Berlin, Germany LEARNING OBJECTIVES: Advantages and disadvantages of virtual systems in a GxP environment Benefits of virtualisation Regulations apply to virtualisation Differences between virtual systems and real systems What are the critical points - during implementation - during qualification and - during operation of virtual systems Virtualisation platform Planning and qualification of a virtualisation project Case studies from virtualisation projects Change management / configuration management and disaster recovery From virtualisation to cloud computing This education course is recognised for the ECA GMP Certification Programme Certified Computer Validation Manager. Please find details at

Virtual IT Systems in a GxP Environment 8-9 November 2018, Berlin, Germany Objectives Get an overview of technologies discussed currently in the pharmaceutical environment and their potential fields

6 Virtual IT Systems in a GxP Environment 8-9 November 2018, Berlin, Germany Objectives Get an overview of technologies discussed currently in the pharmaceutical environment and their potential fields of application, Assess how to use and implement GMP requirements and provisions for virtual IT systems and, where appropriate, for cloud computing, Learn more about the qualification and use of virtual systems in the GMP environment, and Evaluate whether the use of virtual IT systems and cloud computing would be profitable if your company. Background Virtual systems, cloud computing, and GMP; does this fit together? What are the advantages and disadvantages of these systems in a GMP environment? Are there any limits with their use? The increasing use of virtual IT systems and cloud computing in a GMP-regulated environment is getting more and more discussed. The virtualisation of computer systems offers a great number of advantages, such as the simultaneous use of multiple operating systems, the simple and low-cost construction of test environments, and the improved utilisation of multi-core processors. Can these advantages also be used in a GMP environment and which aspects have to be specifically considered from the GMP view for virtual systems and cloud computing? This event considers virtual systems and cloud computing from the GMP point of view and provides practical support to determine measures regarding the use of such systems. Target Audience The event is aimed at managers in the pharmaceutical industry, suppliers and service providers that operate virtual IT systems and cloud computing in a GMP environment or intend to use them in the future. Programme Principles of IT qualification and validation Regulatory requirements Definitions Validation and qualification What is Virtualisation? Definitions Physical platform foundation requirements Software for virtualisation Virtual platform options Benefits of Virtualisation On demand infrastructure Speed of implementation Flexibility Regulations apply to Virtualisation Annex 11 key points for consideration IT infrastructure shall be qualified In-house or hosted system Qualification of IT-Infrastructure General Principles of IT Infrastructure Qualification How to do qualification in a real environment vs. what to do in a virtual environment Qualification Activities Roles and responsibilities Installation and Testing Planning of virtualisation projects User / Technical Requirements Specification Definition of the installation and deployment approach Definition of backup cycles and scenarios From a virtual server to a virtual farm Efficient planning Qualification planning Compliance requirements for virtual systems IT Infrastructure Platform Server Platform Qualification Virtual Platform considerations Maintaining the Qualified State during operation Overview of the virtualisation platform Platform components Platform operation Handling of SANs and VMs Qualification of the virtualisation platform Requirements gathering Platform design Qualification planning Supporting processes

Making of a virtual data centre Specification of virtual data centre requirements Do I qualify or validate the hypervisor software?

NIST-SP 800-30 Risk Management for IT systems HA-Op Virtualisation of laboratory equipment / Desktop virtualisation Use cases for virtualisation in a laboratory environment Operating a virtual system

7 Making of a virtual data centre Specification of virtual data centre requirements Do I qualify or validate the hypervisor software? Building and qualifying a virtual data centre Risk management ASTM E Good Engineering Practice (GEP) Q 9 Quality risk management GAMP 5, M 3 GEP, Qualification, Validation reconciliation NIST-SP Risk Management for IT systems HA-Op Virtualisation of laboratory equipment / Desktop virtualisation Use cases for virtualisation in a laboratory environment Operating a virtual system Show and tell: Virtualisation documentation Technical Requirements Specification Configuration Specifications Installation Qualification Change & Configuration Management Regulatory requirements What is a change? Definitions of change management & configuration management An outline change management process Disaster recovery planning Regulatory requirements for Disaster Recovery Disaster Recovery or Business Continuity Planning? Mitigating physical faults Triggers for the plan Testing the plan Keeping the plan up to date Workshop: Risk-based approach to planning of virtualisation platform The participants should assess and control the risks related to the virtualisation of some critical systems, such as DMS, CDS, ERP, LIMS, process historian Speakers Dr Bob McDowall R.D.McDowall Limited, Bromley, Kent, UK Analytical chemist with over 40 years experience including 15 years working in the pharmaceutical industry and afterwards working for the industry as a consultant. Bob is an ISO assessor and he has been involved with the validation of computerised systems for over 25 years and is the author of a book on the validation of chromatography data systems. He was also a contributor to the GAMP GPG IT Infrastructure control & compliance. Yves Samson Kereon AG, Basel, Switzerland Yves is founder of Kereon AG, Basel. He is member of GAMP Europe Steering Committees, chairman and cofounder of GAMP Francophone and edited the French version of GAMP 4 and GAMP 5. In 2017, Yves launched the e-compliance Requirements Initiative (ecri) with the aim to help the regulated pharmaceutical industry and its suppliers to address and to implement accurately, consistently, and effectively the regulatory e-compliance requirements. Dr Jürgen Schmitz GSK, Wavre, Belgium Jürgen Schmitz was from 1994 until 2000 at RELAB AG and from at KPMG Consulting AG responsible for computer systems validation. Between 2003 and 2015 he was in different positions at global IT Quality Management at Novartis and Novartis Vaccines and Diagnostics. Since 2016 he is Head Quality IT and Compliance at GSK Vaccines. Social Event In the evening of the first course day, you are cordially invited to a social event. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere. From virtualisation to Cloud Computing What is Cloud Computing really? Abstraction of services and IT-infrastructure Virtualisation vs. Cloud Computing Recommendations for a GxP compliant Cloud Computing

8 F F Easy Registration Reservation Form: CONCEPT HEIDELBERG P.O. Box Heidelberg, Germany Reservation Form: info@concept-heidelberg.de Internet: Reservation Form (Please complete in full) If the bill-to-address deviates from the specifications on the right, please fill out here: F Virtual IT Systems in a GxP Environment, 8-9 November 2018, Berlin, Germany F SAP Validation and GMP Compliance, 6-7 November 2018, Berlin, Germany * Mr * Ms Title, first name, surname Company Department Important: Please indicate your company s VAT ID Number P.O. Number (if applicable) Street/P.O. Box CONCEPT HEIDELBERG P.O. Box Fax +49 (0) 62 21/ City Zip Code Country D Heidelberg GERMANY Phone/Fax (please fill in) # Privacy Policy: By registering for this event, I accept the processing of my Personal Data. Concept Heidelberg will use my data for the processing of this order, for which I hereby declare to agree that my personal data is stored and processed. Concept Heidelberg will only send me information in relation with this order or similar ones. My personal data will not be disclosed to third parties (see also the privacy policy at I note that I can ask for the modification, correction or deletion of my data at any time via the contact form on this website. you have to inform us in writing. The cancellation fee will then be calculated according to the point of time at which we receive your message. In case you do not appear at the event without having informed us, you will have to pay the full registration fee, even if you have not made the payment yet. Only after we have received your payment, you are entitled to participate in the conference (receipt of payment will not be confirmed)! (As of January 2012) German law shall apply. Court of jurisdiction is Heidelberg. General terms and conditions If you cannot attend the conference you have two options: 1. We are happy to welcome a substitute colleague at any time. 2. If you have to cancel entirely we must charge the following processing fees: Cancellation - until 2 weeks prior to the conference 10 %, - until 1 weeks prior to the conference 50 % - within 1 week prior to the conference 100 %. CONCEPT HEIDELBERG reserves the right to change the materials, instructors, or speakers without notice or to cancel an event. If the event must be cancelled, registrants will be notified 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. Terms of payment: Payable without deductions within 10 days after receipt of invoice. Important: This is a binding registration and above fees are due in case of cancellation or non-appearance. If you cannot take part, Date Thursday, 8 November 2018, h h (Registration and coffee h h) Friday, 9 November 2018, h h Venue Steigenberger Hotel Berlin Los-Angeles-Platz Berlin, Germany Phone berlin@steigenberger.de Fees (per delegate plus VAT) ECA Members 1,490 APIC Members 1,590 Non-ECA Members 1,690 EU GMP Inspectorates 845 The conference fee is payable in advance after receipt of invoice and includes conference documentation, dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable. Accommodation CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotels. You will receive a room reservation form when you have registered for the event. Reservation should be made directly with the hotel. Early reservation is recommended. Would you like to save money? If you book Virtual IT Systems in a GxP Environment and SAP Validation and GMP Compliance (6-7 November 2018) simultaneously the fee reduces as follows: ECA Members 2,790 APIC Members 2,890 Non-ECA Members 2,990 EU GMP Inspectorates 1,690 Conference Language The official conference language will be English. Organisation and Contact ECA has entrusted Concept Heidelberg with the organisation of this event. CONCEPT HEIDELBERG, P.O. Box Heidelberg, Germany Phone +49(0) 62 21/ Fax +49(0) 62 21/ info@concept-heidelberg.de For questions regarding content: Dr Andreas Mangel (Operations Director) at +49(0) / or at mangel@concept-heidelberg.de. For questions regarding reservation, hotel, organisation etc.: Mr Rouwen Schopka (Organisation Manager) at +49(0) / or per at schopka@concept-heidelberg.de. WA/

Requirements for a GMP-compliant Data Life Cycle May 2016, Berlin, Germany. Karl-Heinz Menges Regierungspräsidium Darmstadt

Data Integrity Workshops on: Analysis of FDA Warning Letters Key Data Integrity Topics / Criteria Assessing a System for Data Integrity Requirements for a GMP-compliant Data Life Cycle 17-19 May 2016,