QbD is experienced in validation and providing support in commissioning end-to-end solutions of SAP Enterprise Resource Planning systems. Thanks to many years of experience – in a wide variety of strictly regulated areas – QbD provides a unique and valuable blend of an efficient quality validation approach.

QbD is proficient in assisting small, mid-sized and large enterprise in implementing the SAP ERP business packages, separately or combined. In addition, QbD validates completely integrated SAP ERP solutions, meeting the specific customer’s needs.

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SAP ERP Cloud and the lifecycle

After the system is validated for use it must stay validated. SAP ERP solutions will require regular updates. Therefore, it is critical to have a systematic approach in order to remain compliant in GxP environments, in which QbD’s expertise lies.

In traditional computer system updates the customers themselves decide whether and when to update. However, a SAP ERP cloud solution will push updates regularly.

Based on SAP S/4HANA, a major update takes place four times a year. Software patches /  hotfix updates take place on a bi-weekly basis[¹]. The customer will be notified of the changes and can use a test environment (Quality Assurance system) to deploy the update and test it first. After approximately three weeks of testing and reviewing the update in the QA system, the update is installed in the live environment (Production system)[²].

SAP quality assurance system and production system

On premise SAP ERP solutions follow a different method. Only one customer uses the system. Therefore, a self-chosen date to deploy the update is possible. SAP ERP releases one major every year. In addition, it’s possible to receive Feature Pack Stacks (FPS) and Service Pack Stacks (SPS) on a quarterly basis, containing smaller updates.  

QbD can support you in the initial validation effort and help you to keep the system validated throughout its lifecycle.
Contact us for any questions concerning SAP.