We care about you and understand that you can only be successful in the market with your products and services if they are set up in the best possible way. For this reason, our cloud-based solutions are created and implemented with great technological know-how in accordance with our own high quality standards.
The outstanding importance of the term quality is reflected in the attention we pay to our company processes and our Software Development Lifecycle.
We work in accordance to the GAMP®5 Supplier Good Practice, covering:
Within our Software Development Lifecycle, we combine the widely-accepted industry standards defined in GAMP®5 Guide with agile development methodologies – to ensure traceability and to verify that the software fulfills its intended use, the agile development cycles (sprints) always cover a complete design-build-test cycle including respective documentation. All procedures are defined in Standard Operating Procedures (SOPs), which are handled following the Good Documentation Practice guide and our QM handbook contains all processes in alignment to ISO 9001:2015.
We are externally audited annually with respect to Software Development and Operations for the regulated industry. The most recent audit was carried out in December 2020 and the audit report is available to our customers on request.
Our UDI Platform is designed to meet the specific requirements of the regulated industry in accordance to 21 CFR Part 11, especially with respect to:
The customer carries out a validation of the processes based on the delivered software according to his requirements and is responsible for compliance with regulatory requirements within his system landscape, in particular for the internal implementation of a change management and for the preparation of a validation report.
In a PaaS-model (e.g. SAP Business Technology Platform), the delivery is based on serverless architectures in order to provide flexible and auto-scaling services to be consumed by end-user applications. Therefore, the ongoing change inspection of a qualified infrastructure to ensure GxP compliance needs to follow a different than the classic approach because of the changed organizational and technical environments.
We support you to bridge the gap between keeping the cloud pace and running software in a safe and reliable way with our GxP Compliance Service – a risk-based approach combined with an (automatic and) continuous re-qualification to verify the qualified state of the SAP Business Technology Platform with respect to the intended use in the applications according to the established GAMP®5 V-Model.
