Challenges of SAP® Validation for Life Science Companies
Overview:
Silvia Martins, CEO, and Co-Founder of FIVE Validation has envisioned this session to help businesses better go through SAP® project including validation challenges.
Very special and skilled panelists were invited to this section where they gave precious tips and recommendations that can shorten your path to a successful project.
“It may be hard for a highly regulated company to convert or migrate or even start with SAP S/4 HANA®. I feel that working together, we can add value to the audience. We could take advantage of this to be part of a positive community to exchange ideas on how to have good projects. Good things need to be shared!”, Silvia Martins.
The following amazing panelists were invited to share their experience with SAP® validation. It’s very likely you have good insights with this event like 'lessons learned.
What was discussed
The following topics were covered:
- Digital transformation journey
- The main challenges of an SAP® implementation project
- Greenfield, Brownfield, and Bluefield approaches
- Sample testing in case of data migration
- Upgrade from SAP ECC® to HANA® database
- Validation strategy
- Benefits of a paperless validation
Special Guests – Panelists
Multidisciplinary team: a very interesting chat
From a Life Science SAP® user point of view
Nikola Dimovski – Alkaloid Skopje
Developed his career mostly in IT&T. Extensive experience in the introduction of innovations and technologies, especially in coordinating and managing projects from both the business and IT aspects. Several larger/more complex projects have been implemented, upgraded, and supported by Nikola: PKIS ERP, BMS, DMS, CRM, SAP ERP®, rollouts in 5 companies, SAP® migration on S/4 HANA®, LIMS, serialization EU, and MES. Head of IT at ALKALOID AD, the most famous Macedonian pharmaceutical company.
Darko Atanasoski – Alkaloid Skopje
Mechanical engineer with a Master of Science in Project Management, and more than 12 years of experience in Pharmaceutical Quality Assurance. Member of the Contamination Control Society of North Macedonia and soft skills training in leadership and validation management. QA Validation Coordinator at ALKALOID AD responsible for organizing and coordination of equipment, production facilities, computerized systems, packaging, cleaning, and transport validation activities.
Mila Palamidovska – Alkaloid Skopje
Bachelor of Mechanical Engineering, Industrial Engineering and Management department, with more than 10 years of experience in Quality Assurance, 5 years in Pharmaceutical industry. Coordinator for Quality Assurance / Computer System Validation in IT department. Taking part in the complete process of Computer System Validation in order to meet the quality standards and adhere to the pharmaceutical cGMP. Working on ensuring Data Integrity, understanding of GAMP5®, risk-based approach to validation, GxP and Computer Systems in support of GxP compliance.
From an implementation vendor point of view
Emerson Vieira – DXC Technology
Graduated in Business Administration from FEA-USP, Emerson has been working in the SAP® ecosystem for over 20 years and has helped companies from various segments in their digital journey with SAP® transformation solutions for conversions to the S/4 HANA® platform, move to cloud cloud, e-procurement, customer, and user experience. Has been working at DXC Technology since 2014, currently as SAP® Pre-Sales Leader for Latin America at DXC, being expert in solution design for complex digital transformation projects, especially S/4HANA® migration/implementation projects and cloud solutions.
From a project manager’s point of view
Rubens Fernandes – Grupo NC, terceiro
Graduated in Computer Science, has been working for almost 40 years with development, implementation, support and management of Information Systems, mainly ERPs. In the 2000s, worked in systems validation projects for multinational healthcare companies and, more recently, in a SAP ECC® Validation project for FDA and ANVISA in a Brazilian multinational pharmaceutical company.
From an expert's point of view of interfacing SAP to satellite systems
Rafael Schirmer – SPI Integradora
Post graduated in Industrial Administration by POLI-USP and bachelor’s degree in information systems, with a solid technical background of 19 years dedicated to the development and implementation of ERP, MES, LES, WMS, Track&Trace systems, cloud solutions, system integrations, and applications of wireless technologies, RFID, and Industrial Internet of Things (IIOT) for industrial process transformation. Deep knowledge of the main global software and hardware platforms for systems and industrial automation. Managing partner of SPI, responsible for the company's Digital area.
From a validation specialist point of view
Silvia Martins – FIVE Validation
Electrical engineer, with almost 20 years of experience in serving Biopharmaceuticals and Medical Devices companies. Trained in England in GAMP5 and FDA 21 CFR Part11, in Germany in SAP® validation, and in Denmark in Data Integrity and Data Governance. CEO and co-founder of FIVE Validation, a promising startup that aims to make compliance faster and simpler
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