Automated Serialization and Compliance Reporting for Konimex
About the Customer
Konimex is a leading pharmaceutical manufacturer based in Indonesia. In addition to manufacturing medicines, food supplements and natural products, Konimex is known as an innovator and early adopter of improved safety and quality assurance procedures in their production practices before they were legally required in Indonesia. Konimex adapts quickly to market challenges with efficient performance, which has kept them relevant in key markets over many decades. This pharmaceutical leader holds firm to its core principles of quality, accessibility and affordability so that everyone has an equal chance at a healthy and happy life.
Project Summary
To adhere to Indonesian Food and Drug Authority (BPOM) regulations, Konimex sought digital solutions that could enable them to serialize products and report warehouse operations, such as shipping and receiving, to the country’s centralized database. To achieve this goal, Konimex implemented a serialization and reporting system with Vison Teknik, which combined serialization and aggregation equipment from Domino with Movilitas.Cloud to record warehouse movements and report to the BPOM system.
Project Activities
- Integrated serialization and aggregation equipment from Domino with Movilitas.Cloud
- Registered product master data and uploaded to BPOM through Movilitas.Cloud
- Created packaging orders from Enterprise Resource Planning (ERP) systems to Movilitas.Cloud through the standard application programming interface (API)
- Enabled reporting of produce and aggregated packs from Domino DSM to Movilitas.Cloud and then to BPOM
- Enabled reporting of shipped and received packs in over 50 warehouses using Movilitas Mobile
Business Drivers
- Ensure compliance by serializing medicines and uploading data to BPOM
- Integrate and automate processes for serialization, aggregation, and reporting to BPOM
- Enable compliance for shipping and receiving for over 50 warehouses
More About the Project
In Konimex’s home market of Indonesia, new regulations were affecting multiple lines of their business. The Indonesian regulatory authority for pharmaceuticals, Badan POM (BPOM) is responsible for protecting and supervising the production of prescribed medicines. Since 2018, all manufacturers in Indonesia have been required to report the details of manufactured prescribed medicines to BPOM (enforcement not yet in effect). To adhere to BPOM regulations, Konimex sought a solution that could enable them to serialize their products and report warehouse operations including shipments and batch details to BPOM.
To achieve Konimex’s goal, the Vison Teknik team set up an automated and integrated serialization and aggregation system consisting of Domino equipment in combination with Movilitas.Cloud for the production facilities producing drugs for the Indonesian market. A connection between Konimex’s production floor, logistics centers and BPOM’s regulatory system was enabled by Movilitas.Cloud, which facilitated compliance without manual reporting and efficiency between manufacturing and shipping activities. This solution ensures regulatory compliance, protects consumers from counterfeit products and enables end-to-end supply chain traceability from material sourcing to pharmacy delivery.
Manufacturing
All phases of packaging were linked to Movilitas.Cloud via Domino’s DSM tool using an API, then all products were fully serialized and integrated into BPOM for reporting. This allowed updates from the shop floor to be accessible immediately in the user interface, showing pack history, SSCC history and batches for any given product code. These codes could be used to report damage or problems across the whole lifecycle.
Logistics
Movilitas.Cloud linked information for both the relevant internal departments and the external destinations receiving products from Konimex, enabling automatic tracking at all levels of distribution. Additionally, Konimex could activate the ‘commissioning while shipping’ function for their warehouse to enable one-time scanning of goods and automatic reporting to BPOM when goods are shipped. Logistics managers in remote offices could then see the status of items and manage shipping, receiving and reaggregation of goods. In essence, this new system effectively managed Konimex’s reporting requirements as a distributor to BPOM.
Regulatory Compliance
Movilitas.Cloud was integrated fully with BPOM’s centralized database, using each entity’s individual credentials and providing all information required by BPOM in the correct format without any manual data imports. Employees could then be notified about any failed messages via email.
Engineering’s Advantage
Engineering’s proprietary solution, Movilitas.Cloud is a ubiquitous Software-as-a-Service (SaaS) technology that makes traceability simple and efficient throughout the global supply chain. Vision Teknik brought their European connections to Domino and brought Eningeering Industries eXcellence to Konimex, knowing that these two providers could help Konimex achieve their digital transformation goals. Our solution enables regulatory bodies, manufacturers and distributors of prescribed medicines to fight counterfeits, protect their brand and keep consumers safe and healthy.
