An ERP for life science such as SAP S/4HANA Cloud enables seamless documentation and monitoring of all regulated processes. Integrated audit trails, electronic signatures, validation processes and approval workflows ensure that legal standards such as GLP, GMP, FDA 21 CFR Part 11 or EU MDR are complied with – in an audit-proof and automated manner.

The ERP integrates quality assurance directly into the production processes. Inspection plans, inspection lots and automatic quality recording are supported by the system. Deviations, feedback and approvals can be documented and tracked in real time. In this way, companies ensure that quality standards are consistently adhered to – from the raw material to the finished product.

SAP Advanced Track and Trace for Pharmaceuticals enables seamless traceability along the entire supply chain. Each batch can be clearly identified, tracked and linked to logistics, quality and production data – a key component in ensuring product safety and regulatory transparency.

With SAP Intelligent Clinical Supply Management, study designs, material planning, shipping, tracking and traceability of clinical samples can be efficiently mapped. The solution helps to avoid under- or over-supply, ensure compliance with study protocols and gain real-time insight into stock levels and consumption.