Many companies have been struggling to plan their migration journey from SAP ECC® to S/4 HANA® in the last few years. Although the SAP® support deadline has been extended, one of the concerns is the shortage of professionals in the market who have knowledge of the project.
For large companies in the Life Science market, the challenge becomes even greater. Planning conversions of this type require patience, rigorous planning, and responsibility, as it can directly affect good manufacturing and distribution practices
To put the GMP® validation project into context, there are two interesting articles on the subject in our blog:
• SAP ECC® and SAP HANA® – Technical Upgrade
• SAP HANA® ERP Validation®
Basically, we can divide the Computer Validation project into two types, validation of SAP S/4 HANA® (change of database and application) and validation of the migration from Oracle ECC® database to S/4 HANA®.
When companies decide to change both the application and the database, there are two main strategies: the Greenfield approach (implementation from scratch) and the Brownfield (software upgrade that preserves all data and settings).
For the Greenfield, one must remember to retain the data in the old ERP, which may be unfeasible for medical device manufacturers, e.g., implant companies may need to keep batch data for the lifetime of the patient.
For both strategies, it is important to evaluate the advantages and disadvantages, as well as the risks associated. Involving a company that specializes in defining regulatory and compliance requirements can help in the decision-making process, compliance with requirements of GxP Pharma, cGMP guidelines, FDA 21 CFR Part 11, GAMP 5, GxP system validation, and GMP validation guidelines.
GxP validation when done on paper is a laborious, bureaucratic, and error-prone activity that can paralyze an operation.
Although each company has its own unique needs, there are several standard processes within a type of system. For example, a purchasing process within an ERP is usually the same process for many companies.
FIVE has experience and has been supporting clients worldwide in such projects since 2008, due to its vast knowledge in computer system validation and relevant GxP processes in ERPs. Electronic validation projects have been used in various company sizes more efficiently (up to 5x faster).
Besides the challenges mentioned above, the SAP S/4 HANA® migration project usually has a high associated cost. There is a shortage of professionals with validation expertise for this type of project. However, FIVE has several services and delivery methods (flexible scope) to meet the client's demand and needs (cost-effectiveness).
You must have already noticed that there are several supply options and that the shape and model will depend on the needs and specific issues of each client. So, should you wish to request a quote or clarify any doubts about these options, please contact us via e-mail [email protected]
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