Entrusted with helping improve the health and lives of millions of people, life sciences manufacturers must prove that they go beyond mere compliance, keeping a comprehensive real-time view into their operations from the shop floor all the way to the top.
In addition to proving compliance, these companies must be able to:
It is likely that regulations will require increasing levels of reporting covering deeper levels of detail across larger areas of the manufacturing, packaging, and shipping processes. Systems that rely on file exchange alone provide no control over what the receiver is doing with the files. Only by having full control over your data can you ensure full visibility and compliance.
Movilitas.Cloud Manufacturer for Pharma application is an easy-to-activate application that helps you ensure compliance with the EU FMD and other regulatory schemes, manage production and packaging, and can act as a level 3 system.
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The Manufacturer application gives you full control over your users and devices, letting you access reports and dashboards in one place to configure access rights intuitively. You can exchange information with systems such as Tracelink or external SAP applications such as SAP ATTP and SAP ICH, and connect directly to services mandated by national authorities such as the EU Hub.
Movilitas.Cloud features a modern, intuitive UI that requires little to no training and can be configured for IT and non-IT needs. Get started in minutes with our self-service cloud. Refreshingly easy to use and simple to configure, Movilitas.Cloud revolutionizes the way products are serialized and verified, making compliance simple.
The Movilitas.Cloud Manufacturer for Pharma application offers a serial number pool to help you manage product serialization effectively and reliably. Serial numbers are linked to global trade item numbers (GTIN) that represent the products. You can create GTINs in the system one by one or upload them from existing master data.
There are two ways to fill the serial number pool for a GTIN. The serial numbers can be either generated in Movilitas.Cloud or you can connect to SAP Advanced Track & Trace for Pharmaceuticals (SAP ATTP) and receive serial numbers from this system.
Movilitas.Cloud Manufacturer for Pharma offers the Serial Shipping Container Codes (SSCC) pool. SSCCs are used to group individual packs of medicinal products and track them. You can create SSCC sequences that follow the GS1 standard for use outside the company. All SSCCs are listed in the SSCC pool where their complete history is available including all status changes.
Create printing destinations (to printing companies such as Graphic West or label software such as Nicelabel) and generate printing orders including the serial numbers in the required format.
In the Manufacturer for Pharma application, you can create packaging lines to establish a connection with your shop floor systems. For example, you can set up a channel with a Wipotec OCS source, creating mappings and specifying up to four aggregation levels for the GTINs included in the mapping. You can use the channel to create a packaging line, then send production orders to the packaging line.
Directly connect to the EU Hub to commission and decommission products, ensuring compliance with the EU Falsified Medicines Directive.
Set up the SAP Blockchain business channel with only a few clicks and send commissioning requests to SAP Blockchain.
Easily connect your complete supply chain network, exchange relevant data and get real-time feedback with the Movilitas.Cloud Business Partner Concept. Instead of complex and long onboarding processes, connect with your supply chain partners with only a few clicks, just like using a social network.
If you are a Marketing Authorization Holder (MAH) or a Contract Manufacturing Organization (CMO) and would like to connect with each other, simply invite them by using their email address and Movilitas.Cloud sends an e-mail request that can be approved or declined. Share all required serialization data with each other.
To follow up on what’s happened to a specific serial number of a GTIN, use the Pack History. This lets you see the complete pack history of individual packs, including every status change. In case of problems, it is easy to understand where and why the problem occurred.
The Manufacturer for Pharma application provides a Manufacturing API, a RESTful API that extends Movilitas.Cloud:
