Explaining Business Scenarios for Supply Coordinator

Users can leverage this application to comprehensively manage medication lists for clinical studies, ensuring accurate tracking and efficient handling of medication numbers. This application provides a detailed suite of functionalities designed for effective medication list management.

Firstly, the application allows users to see a list of studies and filter it by medication list-related issues or by list status. This feature provides a broad overview of all studies while offering the ability to narrow down and focus on specific concerns or statuses. By filtering the list, users can quickly identify studies that require attention, ensuring that any issues are promptly addressed and managed.

Additionally, users can see which lists require medication number sets to be generated or uploaded as files. This functionality highlights the lists that are incomplete or need further action, enabling users to prioritize tasks and ensure that all lists are up-to-date and complete.

The application also allows users to create medication lists. This feature provides the capability to define and establish new lists for clinical trials, ensuring that all medication numbers are systematically organized and managed within the application.

Users can upload files containing medication numbers for a study's kit types directly to medication lists or generate medication number sets within the application. This dual capability enhances flexibility and ensures that users can import existing data or create new data as necessary. By generating or uploading medication number sets, users ensure that all study medications are recorded accurately.

Moreover, users have the option to generate mock medication number sets to share with Interactive Response Technology (IRT) providers. This functionality allows for the creation of trial data sets that can be used for testing and validation purposes, ensuring that all stakeholders have the data needed to support the clinical trial.

The application provides the ability to view all medication numbers in a list, offering detailed visibility into each number. This comprehensive view ensures that users can monitor and verify the inclusion and status of all medication numbers, maintaining accurate records.

In addition, users can map study kit types to the kit types named in uploaded files. This feature ensures that medication numbers are correctly associated with the appropriate kit types, thereby maintaining consistency and accuracy in trial materials.

Users can also export medication number sets to a spreadsheet. This functionality enables users to generate a downloadable and editable document containing all relevant medication numbers, facilitating further analysis, reporting, or data sharing.

The application includes features for approving kit type mapping for uploaded number sets and for approving medication number sets. These approval processes ensure that all data is verified and authorized before being officially integrated into the study records, maintaining data integrity and compliance.

Lastly, users can see at a glance whether there are enough unused numbers left per kit type. This quick view feature provides immediate insights into the availability of medication numbers, helping users to plan and manage their inventories effectively, ensuring that there are no shortages during the clinical trial.

In summary, this application offers a comprehensive and detailed set of tools for managing medication lists in clinical studies. Users can view and filter a list of studies by medication list-related issues or status, identify lists needing action, create and manage medication lists, upload or generate medication number sets, create mock data for testing, view detailed medication numbers, map kit types, export data to spreadsheets, approve mappings and sets, and monitor the availability of unused numbers. These functionalities collectively enhance the efficiency, accuracy, and organization of medication number management in clinical trials.

Users can find detailed information about implementing the app in the SAP Fiori apps reference library.

For latest delivery please see: SAP Fiori Apps Reference Library - Manage Medication Lists

can leverage this application to effectively manage molecule entities, ensuring comprehensive and accurate documentation of each molecule used in clinical studies. This application provides a range of functionalities designed to facilitate the creation, editing, and organization of molecule-related data.

Firstly, users can create a molecule entity and enter an internal name or International Nonproprietary Name (INN) for it. This functionality allows users to define new molecules within the system, providing a specific identification and naming for each molecule. The INN or internal name ensures that the molecule is uniquely recognizable and properly cataloged for reference in clinical trials.

Additionally, users have the capability to edit molecule names. This feature provides the flexibility to update or correct the names of molecules as needed, ensuring that all data remains current and accurate. By editing molecule names, users can accommodate changes in terminology or correct any discrepancies in existing entries.

The application also enables users to see which open label kit types and blinding groups include the molecule. This visibility is crucial for understanding the application and context of each molecule within the study. By identifying the kit types and blinding groups that incorporate the molecule, users can ensure proper tracking and alignment of the molecule within the overall trial structure.

Moreover, users can generate kit type descriptions based on pack size, packaging form, and other parameters. This feature facilitates the creation of detailed and specific descriptions for each kit type, taking into consideration various attributes that define the packaging and presentation of the study materials. Accurate kit type descriptions are essential for clear communication and documentation within the trial.

In addition to generating open label descriptions, users can also generate blinded descriptions based on the descriptions of the blinded kit types. This functionality ensures that even in blinded studies, where the specific details of the kits must remain undisclosed, there are standard and consistent descriptions that can be utilized for regulatory and operational purposes.

The application further supports the editing of generated descriptions. Users can refine and adjust the automatically generated descriptions to ensure they meet the precise requirements and standards of the study. This capability allows for customization and fine-tuning, ensuring that all descriptions are both accurate and tailored to the specific needs of the trial.

In summary, this application provides users with a robust set of tools for managing molecule entities and their associated descriptions. Users can create and name molecule entities, edit molecule names, view associated open label kit types and blinding groups, generate detailed kit type descriptions, create blinded descriptions for blinded kit types, and edit these descriptions to ensure accuracy and compliance. These functionalities collectively enhance the organization, clarity, and efficiency of managing molecules in clinical trials.

Users can find detailed information about implementing the app in the SAP Fiori apps reference library. 

For latest delivery please see: SAP Fiori Apps Reference Library - Manage Molecule-Based Descriptions for Printing

Users can utilize this application to efficiently manage and monitor a wide range of supply and production orders, ensuring the smooth execution and tracking of clinical trial logistics. This application provides a comprehensive set of tools designed to handle orders, master data readiness, and related issues, enhancing operational efficiency and accuracy.

Firstly, the application allows users to view the status of open supply orders, whether for internal packaging or external packaging. This functionality provides real-time insights into the progress of supply orders, helping users track the current status and ensure that packaging processes are on schedule. By monitoring the status of these orders, users can identify any delays or issues early and take the necessary steps to address them.

Additionally, users can view orders with issues. This feature highlights any supply orders that are experiencing problems, enabling users to focus their attention on resolving these issues promptly. By identifying and addressing problematic orders, users can minimize disruptions and maintain the integrity of the supply chain.

The application also enables users to view studies with Protocol Change Notices (PCNs) for which a shelf life extension is possible. This functionality alerts users to opportunities for extending the shelf life of study materials, ensuring that resources are utilized efficiently and effectively. By staying informed about potential shelf life extensions, users can make informed decisions that benefit the continuity and success of their clinical trials.

Furthermore, users can view studies with PCNs for which a shelf life extension is planned. This feature provides visibility into upcoming shelf life extensions, allowing users to prepare and coordinate accordingly. By keeping track of planned extensions, users can ensure that all necessary actions are taken in a timely manner.

Users can also view orders that are ready for external production or internal production. This functionality provides a clear indication of which orders are prepared and awaiting processing, helping users organize and prioritize their production activities. By monitoring readiness for production, users can streamline workflows and ensure efficient use of resources.

The application allows users to view only open orders that they, or another selected user, are responsible for. This personalized view ensures that users can focus on their direct responsibilities, enhancing accountability and efficiency. By filtering orders based on responsibility, users can manage their tasks more effectively and maintain control over their assigned duties.

Additionally, users can check the readiness of master data. This feature ensures that all necessary data is complete and accurate before proceeding with production and supply activities. By verifying master data readiness, users can prevent errors and ensure that processes run smoothly.

The application also enables users to view issues relating to master data, grouped by issue type, such as study, material, shelf life, label, or medication list. This organized view helps users quickly identify and address specific data problems, ensuring that all aspects of the study are properly managed. By categorizing issues, users can streamline their problem-solving efforts and maintain data integrity.

Lastly, users can navigate from an issue to the relevant object, such as a material, displayed in the corresponding app. This functionality allows users to quickly access detailed information about the specific object related to an issue, facilitating efficient resolution. By directly navigating to the relevant details, users can save time and enhance accuracy in addressing problems.

In summary, this application offers users a robust set of tools to manage supply orders, production readiness, and master data issues. Users can view the status of open supply orders, identify and resolve problematic orders, monitor studies with potential or planned shelf life extensions, track production readiness, filter orders by user responsibility, check master data readiness, view categorized master data issues, and navigate to relevant objects for detailed information. These functionalities collectively enhance the efficiency, accuracy, and effectiveness of clinical trial logistics and data management.

Users can find detailed information about implementing the app in the SAP Fiori apps reference library.

For latest delivery please see: SAP Fiori Apps Reference Library - Clinical Supply Status Overview

Users can utilize this application to effectively manage and filter supply orders, ensuring comprehensive oversight and control over clinical trial logistics. This application offers a broad array of functionalities designed to enhance the efficiency of supply order tracking and management.

Firstly, users can filter the supply orders by various criteria, such as due date range, study, responsible employee, Protocol ID, Commodity Flow Group (CFG), component material, and more. This functionality allows users to narrow down large volumes of orders to focus on those that are most relevant to their needs. By applying filters, users can quickly access specific subsets of orders based on detailed criteria, facilitating targeted and efficient management.

Additionally, users can identify initial supply orders for which no Protocol Change Notice (PCN) has been released and no packaging has been performed yet. This feature helps users pinpoint orders that are still in the preliminary stages, ensuring that necessary actions are taken to advance these orders through the supply chain processes. By identifying these initial orders, users can prevent delays and ensure timely progression.

The application also provides the ability to navigate to a page displaying open supply orders for a specific study. This allows users to focus on and manage all outstanding orders associated with a particular study, enabling a consolidated and organized approach to order tracking and fulfillment for that study.

Furthermore, users can choose a CFG and navigate to a page showing open supply orders that include the selected CFG. This functionality enables detailed tracking of orders based on specific commodity flow groups, ensuring that users can effectively manage the flow of materials within defined groups and maintain a streamlined supply chain.

The application allows users to choose a material and navigate to a page showing open supply orders for CFGs that include the selected component material. This feature ensures that users can track and manage orders based on specific materials included in the commodity flow groups, providing insights into the supply status and requirements of particular components.

In addition, users can see an overview of demand per country for a selected order. This offers a comprehensive view of how the demand for trial materials is distributed across different countries, enabling users to plan and allocate resources effectively. By understanding country-specific demand, users can better coordinate international logistics and ensure timely delivery of trial materials.

The application supports the ability to work on different clinical supplies simultaneously in multiple sessions. This functionality enhances operational efficiency by allowing users to manage and process multiple supply orders concurrently, ensuring that various aspects of clinical trial logistics are addressed without delay.

Lastly, users can check for missing orders for CFGs in a blinding group within the selected due date range. This feature helps ensure that all necessary orders are in place for the proper execution of blinded studies. By identifying any missing orders within the specified timeframe, users can take prompt corrective actions to avoid disruptions in the trial process.

In summary, this application provides a comprehensive set of tools for filtering and managing supply orders. Users can apply detailed filters, identify preliminary orders, navigate to specific pages for studies, CFGs, and materials, view country-specific demand overviews, manage multiple sessions simultaneously, and check for missing orders in blinding groups. These functionalities collectively enhance the efficiency, accuracy, and organization of clinical trial supply chain management.

Users can find detailed information about implementing the app in the SAP Fiori apps reference library.

For latest delivery please see: SAP Fiori Apps Reference Library - Clinical Supply Orders

Users can utilize this application to efficiently manage and optimize the supply chain for clinical trials, leveraging a comprehensive suite of functionalities designed for enhanced control and flexibility.

Firstly, users can view and change simulation rules used to calculate system proposals. This functionality allows users to customize and fine-tune the rules that the system uses to generate supply chain proposals. By adjusting these simulation rules, users can ensure that the system's recommendations align closely with their strategic objectives and operational requirements.

In addition, users can enter additional storage locations of batch stock to be considered, beyond just the header and component storage locations of an order. This feature ensures a more complete and accurate assessment of available inventory by including all relevant storage locations in the planning process. By accounting for additional storage locations, users can optimize inventory utilization and prevent stock shortages or excesses.

The application also allows users to view demand per country for an order. This offers a detailed overview of how demand is distributed across different geographic regions, facilitating informed decision-making and efficient allocation of resources. By understanding country-specific demand, users can better coordinate the logistics of trial materials and ensure timely delivery.

Users can identify initial supply orders for which no Protocol Change Notice (PCN) has been released and no packaging has been performed yet. This functionality helps users recognize orders that are still in the preliminary stages, ensuring that necessary actions are taken to advance these orders through the supply chain process. Identifying initial orders helps prevent delays and ensures a smooth progression of the supply chain.

The application enables users to manually allocate batches to all orders or to selected orders. This feature provides flexibility in managing inventory by allowing users to make precise allocations based on specific needs and priorities. Manual batch allocation ensures that critical orders receive the necessary stock, optimizing the use of available resources.

Furthermore, users can navigate to batch and stock information for allocated batches. This functionality offers detailed insights into the status and properties of the batches that have been allocated, facilitating better tracking and management of inventory. By accessing batch and stock information, users can ensure that all allocations are accurate and up-to-date.

The application also allows users to create PCNs and assign countries to them. This functionality helps users manage regulatory changes and adjustments required for clinical trials, ensuring that all necessary documentation and approvals are in place. Assigning countries to PCNs helps maintain compliance with local regulations and requirements.

Users can change the assignment of countries to a PCN to optimize the expiry date. This feature enables users to strategically manage the shelf life of trial materials by reassigning countries based on their specific regulatory and logistical needs. Optimizing expiry dates ensures that materials remain viable throughout the trial duration.

Additionally, users can select a different expiry date for a PCN, such as choosing to pack on risk by using a filed or planned shelf life instead of the approved shelf life. This functionality provides flexibility in managing expiry dates, allowing users to balance risk and operational efficiency. Selecting alternate expiry dates can help address unforeseen challenges and ensure the continuous availability of trial materials.

Users can save their decisions and allocate the batches accordingly, ensuring that all inventory management actions are documented and executed as planned. This feature allows for the consistent and accurate implementation of supply chain strategies.

The application supports splitting order quantities to create multiple new orders. This functionality allows users to divide large orders into smaller, more manageable segments, facilitating better planning and execution. Splitting orders helps optimize resource allocation and streamline the supply chain process.

Lastly, users can release all or some of the orders that are ready for packaging. This feature ensures that completed and verified orders are promptly moved to the packaging stage, maintaining the flow of materials through the supply chain. By releasing ready orders, users can prevent bottlenecks and ensure timely delivery of trial materials.

In summary, this application provides a robust set of tools for managing and optimizing the clinical trial supply chain. Users can view and adjust simulation rules, include additional storage locations, assess country-specific demand, identify initial orders, manually allocate batches, access batch information, create and manage PCNs, optimize expiry dates, save allocation decisions, split orders, and release packaging-ready orders. These functionalities collectively enhance the accuracy, efficiency, and effectiveness of clinical trial logistics management.

Users can find detailed information about implementing the app in the SAP Fiori apps reference library.

For latest delivery please see: SAP Fiori Apps Reference Library - Validate Clinical Batches and Expiry Dates

Users can leverage this application to efficiently manage shelf life data for clinical study materials, ensuring accuracy and compliance across various jurisdictions. This comprehensive tool allows users to carry out several critical tasks related to the shelf life of trial materials.

Firstly, users can create a shelf life version for a combination of study and primary pack material or for a study-flavor ID combination. This functionality enables precise customization and management of shelf life data specific to the material configurations used in different studies. Creating distinct shelf life versions helps ensure that each combination of study material is accurately tracked and managed according to its unique requirements.

In addition, users can enter the validity period for each shelf life version. This involves specifying the duration that the material remains viable and safe for use. By entering the validity period, users can ensure that the shelf life data reflects the actual lifespan of the materials, helping to maintain the integrity and safety of the clinical trial.

The application also supports entering and editing country-specific shelf lives. This feature is essential for multinational studies, as it allows users to define and adjust the shelf life durations for different countries based on local regulations and requirements. By managing country-specific shelf lives, users can ensure compliance with diverse regulatory standards and optimize the use of materials globally.

Furthermore, users can specify whether the material is approved for use in each country. This functionality permits users to indicate the authorization status of materials in various regions, ensuring that only approved materials are utilized in specific countries. Tracking approval statuses helps maintain regulatory compliance and avoids the risk of using unapproved materials in clinical trials.

The application offers options for limited, unlimited, or no shelf life auto-approval. Users can select the level of automation for approving shelf lives based on their operational needs and regulatory environment. Limited auto-approval might require manual checks for some criteria, unlimited auto-approval fully automates the process, and no auto-approval ensures all approvals are manually reviewed. This flexibility allows users to align the approval process with their quality control policies.

Additionally, users can choose whether to synchronize the shelf life data with a Regulatory Information Management (RIM) system. Synchronization ensures that the shelf life information is consistent and up-to-date across different systems, promoting enhanced data integrity and regulatory compliance. By linking to a RIM system, users can streamline data management and reduce the risk of discrepancies.

The application allows users to indicate whether only the Investigator's Brochure is relevant for a country. For specific regions, the Investigator’s Brochure may contain sufficient information regarding the materials, and this feature ensures that the proper documentation requirements are met without unnecessary duplication. Indicating the relevance of the Investigator's Brochure helps tailor the compliance approach to meet regional standards effectively.

Lastly, users can view the packaging-relevant shelf lives calculated by the system. This functionality provides a clear overview of the viable shelf life of materials based on their packaging configurations. By viewing these calculated shelf lives, users can ensure that materials are packaged and utilized within their effective lifespan, thereby maintaining quality and compliance throughout the clinical trial.

In summary, this application equips users with a comprehensive suite of tools for managing shelf life data of clinical study materials. Users can create and manage shelf life versions for specific study-material combinations, enter and edit validity periods and country-specific shelf lives, track material approval statuses, choose auto-approval settings, synchronize data with RIM systems, indicate documentation relevance, and view system-calculated shelf lives. These functionalities collectively enhance the accuracy, compliance, and efficiency of managing shelf life data in clinical trials.

Users can find detailed information about implementing the app in the SAP Fiori apps reference library. For latest delivery please see: SAP Fiori Apps Reference Library - Manage Shelf Life Data

Users can utilize this application to effectively manage Protocol Change Notices (PCNs) and related activities, ensuring streamlined operations and accurate tracking within clinical trials. This application offers a comprehensive range of functionalities designed to enhance the efficiency and effectiveness of clinical trial management.

Firstly, the application allows users to view PCNs whose orders have already been packed. This functionality provides users with real-time insights into the status of PCNs, allowing them to track which orders have been processed and are ready for further steps in the trial process. By viewing packed orders, users can ensure that all necessary packaging has been completed and prepare for subsequent actions.

In addition to tracking packed orders, users can view PCNs whose orders are still in preparation. This feature highlights PCNs that are yet to be finalized, enabling users to monitor the progress of these orders and identify any potential delays or issues. By keeping track of orders in preparation, users can ensure timely completion and maintain the trial schedule.

The application also enables users to view PCNs for which a shelf life revision has been started, but goods receipt has not been performed for the relabeling orders. This functionality ensures that users can identify PCNs that are in the midst of shelf life adjustments, allowing them to manage and complete the necessary relabeling steps. By tracking these PCNs, users can ensure that all shelf life revisions are properly executed and updated in the system.

Furthermore, users can view stock information on both batch and depot levels. This functionality provides detailed visibility into the inventory status, helping users manage and allocate stock efficiently across different locations. By accessing batch and depot-level information, users can optimize inventory usage and ensure that clinical trial materials are available when needed.

The application allows users to see the impact of a different expiry date. This feature provides insights into how changes in expiry dates affect the overall supply chain and inventory management. By analyzing the impact of expiry date adjustments, users can make informed decisions to optimize the shelf life and usability of trial materials.

Users can filter the list of PCNs by various criteria such as study, PCN ID, PCN status, study status, and more. This advanced filtering capability enables users to pinpoint specific PCNs based on detailed parameters, making it easier to manage and track relevant notices. By applying filters, users can streamline their workflows and focus on the most critical issues.

Additionally, users can change the expiry date of a PCN that is in preparation or does not require relabeling. This functionality allows for the adjustment of expiry dates to ensure that materials remain compliant and usable throughout the trial duration. By updating expiry dates, users can maintain the integrity and efficacy of trial materials.

The application also supports planning a shelf life revision or relabeling for a PCN. Users can organize and schedule the necessary steps to update the shelf life or relabel materials, ensuring that all regulatory and logistical requirements are met. By planning these revisions, users can proactively manage changes and maintain trial continuity.

Furthermore, users can plan and initiate the printing of labels for relabeling kits that are at clinical sites. This functionality ensures that all necessary labeling is completed accurately and efficiently, maintaining compliance with study protocols. By initiating label printing, users can ensure that relabeled kits are properly documented and traceable.

Users can also initiate label printing for planned relabeling orders with a specified label material and at a specified print location. This capability allows users to customize the labeling process to meet specific requirements, ensuring that all trial materials are clearly and correctly labeled.

The application provides functionality to initiate relabeling at the depot level. This ensures that relabeling activities can be managed and executed at the depot, maintaining control over the process and ensuring compliance with regulatory standards.

Additionally, users can trigger the cancellation of relabeling and print orders. This functionality allows users to halt any unnecessary or erroneous orders, ensuring that resources are not wasted. By managing cancellations, users can maintain an efficient workflow and prevent operational disruptions.

Finally, users can confirm the cancellation of orders once they have been deleted or technically completed. This confirmation step ensures that all order cancellations are properly documented and finalized in the system, maintaining accurate records and ensuring compliance.

In summary, this application provides users with a robust set of tools for managing PCNs and related processes. Users can track the status of orders, view stock information, analyze expiry date impacts, filter and manage PCNs, plan shelf life revisions and relabeling, initiate label printing, trigger and confirm order cancellations, and much more. These functionalities collectively enhance the efficiency, accuracy, and compliance of clinical trial management.

Users can find detailed information about implementing the app in the SAP Fiori apps reference library. For latest delivery please see: SAP Fiori Apps Reference Library - Manage PCNs

Users can utilize this application to efficiently manage Protocol Change Notices (PCNs) and related activities, ensuring streamlined operations and accurate tracking within clinical trial logistics. The application provides a comprehensive set of functionalities to manage and monitor PCNs effectively.

Firstly, users can view PCNs whose orders have already been packed. This feature provides real-time insights into the status of PCNs, allowing users to track which orders have been completed and packed for shipment. By viewing packed orders, users can confirm that these orders are ready for the next stages in the clinical trial process, ensuring a smooth and organized flow of materials.

In addition, users can also view PCNs whose orders are still in preparation. This functionality helps users monitor the progress of ongoing orders, identifying those that are in the preparation phase and ensuring they are on track for timely completion. By keeping an eye on these orders, users can preemptively address any potential delays or issues that might arise.

The application also allows users to view PCNs for which a shelf life revision has been started, but goods receipt has not been performed for the relabeling orders. This feature highlights PCNs that are currently undergoing changes to their shelf life, ensuring that users are aware of orders awaiting goods receipt for relabeling. By tracking this status, users can prioritize these orders for completion and ensure that shelf life revisions are duly processed.

Furthermore, users can filter the list of PCNs by PCN status or identify where there is a risk of expiring stock. This advanced filtering capability allows users to focus on specific PCNs based on their status or tackle potential issues related to stock expiration. By applying these filters, users can efficiently manage their priorities and address critical concerns promptly.

The application provides the functionality to view the minimum expiry date and the latest possible revised expiry date of PCNs. This feature offers users insights into the current and potential future viability of stocked materials. By examining these dates, users can make informed decisions about necessary revisions and the management of expiry risks.

Additionally, users can view the Commodity Flow Group (CFG) materials, the estimated quantity of expiring stock, and the estimated date on which the stock will be used up. This detailed information helps users understand the scope of expiring materials and plan accordingly. By knowing the specific materials and their quantities at risk of expiration, users can take proactive measures to extend shelf life or accelerate usage.

The application also enables users to navigate to a PCN in the Manage PCNs app to plan or initiate relabeling or a shelf life revision. This seamless navigation capability allows users to directly access and manage the PCNs requiring action, whether it’s for relabeling or updating shelf life data. By providing a straightforward pathway to these critical tasks, users can ensure timely and efficient execution of necessary adjustments.

In summary, this application equips users with essential tools to view and manage PCNs efficiently. Users can track the status of packed and in-preparation orders, monitor shelf life revision processes, filter PCNs by status or expiry risk, view key expiry dates, assess expiring stock details, and navigate to the Manage PCNs app to plan and initiate necessary actions. These functionalities collectively enhance the accuracy, efficiency, and organization of clinical trial material management.

Users can find detailed information about implementing the app in the SAP Fiori apps reference library. For latest delivery please see: SAP Fiori Apps Reference Library - Manage Shelf Life Revisions

Users can leverage this application to efficiently manage regulatory alerts and ensure compliance with shelf life data requirements in clinical trials. The app provides a comprehensive suite of functionalities designed to keep users informed and responsive to changes affecting regulatory data.

Firstly, the application allows users to view and filter a list of regulatory alerts. These alerts are triggered by several factors, including changes to data received via a Regulatory Information Management System (RIMS) interface, manual changes made in the Manage Shelf Life Data app, or modifications to the total shelf life of a primary pack material. By offering this functionality, users can stay updated on significant changes and swiftly address issues that may impact the regulatory compliance of their clinical trial materials.

Additionally, users can view only the regulatory alerts related to the studies they are responsible for. This feature ensures a focused and tailored view of alerts, enabling users to concentrate on the most relevant information without the distraction of unrelated data. By narrowing down alerts to those that pertain to their specific responsibilities, users can more effectively manage and respond to pertinent changes.

The application provides an at-a-glance overview of the country involved and the extent of the reduction when an approved shelf life has been decreased in months. This quick access to critical information allows users to promptly understand the impact of regulatory changes on a country-by-country basis, facilitating immediate and informed decision-making.

Users can also see at a glance how the total shelf life of a material has changed, including the duration in months. This information is crucial for tracking the longevity and usability of clinical trial materials, ensuring that users can monitor and react to any significant shifts in shelf life data.

Furthermore, the application enables users to view a list of all Protocol Change Notices (PCNs) impacted by a regulatory data change. This comprehensive view helps users understand the broader effects of a regulatory update, ensuring that all affected PCNs are identified and managed appropriately.

The application allows users to navigate from an alert in the list report to the relevant shelf life data set or material master. This seamless navigation capability ensures that users can directly access detailed information about the changes triggering the alert, enabling a thorough review and analysis of the data involved.

Moreover, users can navigate from alert details to a related PCN, Commodity Flow Group (CFG) batch, or CFG. This interconnected navigation ensures that users can quickly find and manage related elements of the clinical trial, facilitating a cohesive and streamlined approach to regulatory compliance management.

Users also have the ability to acknowledge a single alert or select multiple alerts to remove them from the list. This functionality allows users to manage their alert list efficiently, marking alerts as reviewed and addressing issues as they arise. Acknowledging alerts helps maintain an organized workflow and ensures that only outstanding actions require attention.

In summary, this application provides users with extensive tools to manage regulatory alerts related to shelf life data. Users can view and filter alerts based on changes received via RIMS or manual adjustments, view alerts specific to their studies, and see critical information about shelf life reductions and changes. Additionally, users can access related PCNs, navigate to detailed data sets, and acknowledge alerts to maintain an organized and responsive regulatory management process. These functionalities collectively enhance users' ability to maintain compliance, efficiently manage changes, and ensure the integrity of clinical trial materials.

Users can find detailed information about implementing the app in the SAP Fiori apps reference library. For latest delivery please see: SAP Fiori Apps Reference Library - Regulatory Alert Overview