Manoel Costa, PMP®’s Post

Exciting news! 🌟 We've just released a comprehensive white paper that dives deep into how our product, SAP Digital Manufacturing(DM), operates in regulated environments. 📑 This white paper provides insights into how SAP DM not only understands but also meticulously depicts and implements GxP standards operationally, technically, and functionally. 💼🔍 Check it out now! 📈 #LifeSciences #SAPDigitalManufacturing #GxPCompliance #Regulations #Digitalmanufacturingcloud #Compliance #SAP

SAP Digital Manufacturing in Regulated Environments, Quality and Compliance Life Science Customers are subject to strict regulatory surveillance and must prepare themselves to demonstrate their compliance efforts with regulators. Although Life Science Customers are solely responsible for assuring compliance with GxP laws and practices, SAP ensures that GxP- guidelines are followed to demonstrate minimal viable compliance. SAP summarizes specific GxP-relevant information for SAP Digital Manufacturing, as follows: ● The technical and procedural measures and controls. ● Its institutional knowledge to develop and operate SAP Digital Manufacturing in a controlled state. ● How SAP ensures the confidentiality, integrity, and availability of customers' data. Such information enables Life Science Customers to assess their compliance with GxP. To make this information more accessible, this White Paper consolidates and further highlights GxP-relevant aspects, like SAP Digital Manufacturing's Quality Management System (QMS), Software Development Operational Lifecycle (SDOL), and IT Operations and Services. Read the White Paper here: https://buff.ly/3PLxd2u Do you find these assets valuable? 🚀 Like and share to spread the knowledge! 🌐💙 #SAP #DMC #sapdmc #DigitalManufacturingCloud #BestRunSAP #Industry4

What does SAP Batch Release Hub (BRH) give me I’ve implemented SAP QM in 5 Pharmaceutical companies and all these companies have defined bespoke code to assess the batch being released and any of its components to determine if there are out of specification result, open deviation, open change controls and whether any components have an interim release (manufacturing under risk). Each of these companies has delivered these business requirements in a different way and all have their own complex code that needs full lifecycle maintenance. BRH privides a standardised solution to meet the above requirements that is maintained by SAP and allows for configuration to meet the local business needs, e.g. notification types related to deviations, notification statuses that define when a deviation is complete etc. In addition it’s possible to use the provided BADIs in S/4 to extract specific data to sent to BRH and bespoke BRH rules can be defined to interpret the data received from S/4. https://lnkd.in/eyH24r2c