What is SAP ICH Life Sciences?

With SAP ICH Life Sciences (Information Collaboration Hub for Life Sciences), companies in the pharmaceutical industry realise a smooth exchange of data with supply chain partners and authorities.

This reduces costs, increases legal certainty and improves patient safety at the same time.

SAP ICH Life Sciences is the abbreviation for SAP Information Collaboration Hub for Life Sciences. As the name suggests, it is a platform for collaboration between partners from the life sciences industry. This includes the pharmaceutical industry in particular.

The cloud solution was developed to connect pharmaceutical companies and their partners along the supply chain within a secure network. This networking is particularly important for consistent communication, monitoring the supply chain and fulfilling regulatory requirements. The hub complies with international legislation with regard to the serialisation of medicines and compliance reporting.

SAP ICH Life Sciences is technically based on SAP HANA. This enables the platform to store and process large volumes of data - in particular serialisation and traceability data for medicinal products - and make it available to all stakeholders in real time. The solution is fully managed by SAP. The software manufacturer is also responsible for onboarding the partners involved.

SAP ATTP and SAP ICH Life Sciences are closely linked, but have different areas of application.

• SAP ATTP is used as an internal company tool (backbone) for managing serialisation and traceability data.
• SAP ICH Life Sciences, on the other hand, acts as an external communication platform that enables the exchange of this data with partners, distributors, pharmacies and authorities.

The combination of both solutions ensures that pharmaceutical products can be distributed worldwide in a safe, traceable and legally compliant manner.

The SAP Information Collaboration Hub for Life Sciences has three main objectives:

• Secure exchange of serialisation data
• Fulfilment of regulatory reporting requirements
• Optimisation of supply chain processes

The platform provides five central functions for this purpose, which are described in more detail below:

1. Supply Chain Partner Collaboration: Collaboration with partners in the supply chain

Firstly, SAP ICH enables the secure and standardised exchange of serialisation and traceability data within the pharmaceutical supply chain. This is achieved with the help of the following features:

• Linking all relevant players: marketing authorisation holders (MAH), wholesalers, contract manufacturers (CMO), third-party logistics providers (3PL), dispensing points (pharmacies) and regulatory authorities can communicate with each other via a central platform and exchange serialisation data in real time.
• Standardised communication: The hub ensures that all data formats and reporting structures comply with regulatory requirements. This reduces errors and minimises the manual effort involved in transmitting serialisation information to partners.
• Automated transaction processing: SAP ICH Life Sciences can automatically process and validate serialisation data. In the event of data errors or discrepancies, the system has mechanisms for correction and retransmission.
• Networking with global systems: Pharmaceutical companies generally operate internationally and therefore need to connect with different regulatory systems. SAP ICH therefore supports numerous country-specific data requirements. This ensures that companies work in compliance with the law worldwide.

2. Regulatory reporting: automated regulatory reporting

SAP ICH Life Sciences was developed to ensure the regulatory compliance of pharmaceutical companies. The platform therefore also supports the automated creation and transmission of regulatory reports to authorities and partners.

The following legal requirements are supported:

• EU Falsified Medicines Directive (FMD) (valid for Germany, Austria and Switzerland, among others)
• US Drug Supply Chain Security Act (DSCSA)
• China Drug Administration Law
• Other regional regulations

The system also generates the necessary serialisation reports before a product is delivered. These reports can then be transmitted digitally to authorities or partners.

In addition, companies in the pharmaceutical industry are obliged to forward product transactions and verification information to legal reporting systems. SAP ICH also handles this process, ensuring error-free and standardised data transmission.

3. Web applications for managing serialisation data

SAP ICH Life Sciences also includes a range of user-friendly web apps. These support pharmaceutical companies in efficiently managing their serialisation data and product movements.

For example, the web apps give users access to a central dashboard that displays all serialisation events. This allows companies to track in real time where their products are currently located and whether they have been successfully verified.

The web apps can also be used to perform various actions relating to the management of serialisation events. These include

• Requesting new serial numbers
• Transmission and processing of serialisation data
• Verification and release of notifications to authorities

The apps also provide advanced search and filter functions. These help companies to search for products by serial number, batch or transaction status and thus track the status of a medicine within the supply chain.

4. Integration with SAP Advanced Track and Trace for Pharmaceuticals (SAP ATTP)

As already mentioned, SAP ICH Life Sciences is closely integrated with SAP ATTP. Both systems complement each other and ensure that companies have complete control over their serialisation data. The integration fulfils the following requirements:

• Connecting internal and external processes: SAP ATTP is used to create and manage serial numbers within a company. SAP ICH Life Sciences serves as an external platform for exchanging this data with partners, authorities and pharmacies.
• Automatic synchronisation of data: Companies can automatically transfer serialisation information recorded in SAP ATTP to SAP ICH Life Sciences. This eliminates the need for manual data entry and prevents errors.
• Efficient reporting of serialisation events: Data from SAP ATTP can be used directly for regulatory reports or supply chain notifications and forwarded to the appropriate parties via SAP ICH Life Sciences.

5. Onboarding and support for supply chain partners

Last but not least, SAP ICH includes comprehensive onboarding services. These ensure that companies and their partners can use the hub quickly and efficiently. The service portfolio includes the following components:

• Step-by-step introduction for new partners: provision of detailed instructions for connection, support for integration with existing IT systems, technical advice on optimising reporting interfaces
• Customer support for operations: access to support teams to assist with questions about data transfers, regulatory requirements and technical interfaces
• Training for employees: SAP offers specialised training and webinars to ensure that companies can make the best use of the platform.

Pharmaceutical companies face the challenge of complying with international regulations and maintaining efficient logistics processes at the same time. This is precisely where SAP ICH Life Sciences comes in.

The platform automates the exchange of serialisation information, inventory data and product movements within the supply chain. This minimises the risk of counterfeiting and increases patient safety. At the same time, the manual effort required for the corresponding compliance measures is reduced.

SAP ICH Life Sciences also improves transparency in the pharmaceutical supply chain by providing real-time data analyses for monitoring product movements. Companies can therefore continuously track production and logistics processes and react to delays or bottlenecks at an early stage. By comparing serialisation and transaction data with production schedules, deviations can be detected before they lead to problems.

If a product is not verified or delivered as planned, the system sends alerts so that companies can make immediate adjustments. This optimises control of the entire supply chain and helps to avoid interruptions in supply.

Compliance with regulatory requirements is of crucial importance for the pharmaceutical industry. In this context, SAP ICH Life Sciences ensures that all necessary information on drug shipments, serialisation data and transaction histories is documented and can be retrieved at any time.

Predefined interfaces to global regulatory authorities enable reports to be created and transmitted automatically. Companies no longer have to manually transfer data in different formats, but can rely on standardised and secure data transfer.

The integration of SAP ICH Life Sciences into existing supply chain management systems enables optimised coordination of the entire delivery process. As all relevant players are connected within a centralised platform, errors in logistics are reduced and inefficient processes are avoided.

The platform also offers options for the automated documentation of transport processes. This allows companies to track which products are where at any time and whether delivery times are being met.

This feature also makes SAP ICH attractive for other sectors. For example, companies from the automotive, tobacco, fashion and milk sectors are also becoming SAP ICH customers. This is simply because the hub significantly simplifies the networking of business partners and accelerates their onboarding.

Overall, SAP ICH Life Sciences comes with a whole range of benefits. These can be summarised as follows:

• Reduced compliance effort: Automated reporting and standardised data transmission eliminate the need for manual preparation of regulatory reports.
• Greater security in the supply chain: counterfeit or unauthorised medicines are immediately detected and stopped by serialisation checks.
• Avoidance of supply bottlenecks: Real-time data analyses help to identify disruptions in the supply chain at an early stage and proactively avoid bottlenecks.
• Efficient collaboration with partners: Suppliers, pharmacies and wholesalers can exchange serialisation data in a secure and standardised way, which speeds up processes, reduces errors and cuts costs.

SAP ICH Life Sciences is fully compatible with other SAP systems such as SAP ATTP, SAP ERP and SAP S/4HANA. Firstly, it is important to integrate ATTP and ICH, which is realised via the SAP Cloud Connector.

SAP ICH can and should also be connected to SAP ERP or SAP S/4HANA. This allows end-to-end business processes to be realised in the areas of logistics, production and quality management.

The implementation of the SAP Information Collaboration Hub for Life Sciences requires careful planning and technical realisation. The process includes the connection to SAP Advanced Track and Trace for Pharmaceuticals (SAP ATTP) and the existing ERP system (SAP ECC or SAP S/4HANA). SAP partners provide support here.

Before use, pharmaceutical companies must also register and invite their partners (if not already present on SAP ICH) to participate. This process is summarised as follows:

• Registration of the MAH: The Marketing Authorisation Holder (MAH) registers in the hub.
• Invitation of partners: The MAH invites its partners such as Contract Manufacturing Organisations (CMOs) and Third-Party Logistics Providers (3PLs) to participate in the network.
• Onboarding support: The onboarding process is supported by the SAP ICH onboarding team.
• Choice of connectivity option: Depending on requirements, partners can either use the web app for manual data entry or B2B integration for automated system communication.
• Use of SAP Cloud Platform Integration Services: Data is exchanged between partners via SAP Cloud Platform integration services.

There are currently no official training courses for SAP ICH Life Sciences from the software manufacturer. However, implementation partners can set up customised training courses for their customers if required.

In addition, the SAP Help Portal provides comprehensive documentation and guides that explain the functions and implementation details of SAP ICH.