Serialization Site Manager (SSM)

Vimachem's Serialization Site Manager (SSM) is a Level 3 serialization and aggregation software platform designed for pharmaceutical manufacturers seeking comprehensive track-and-trace capabilities. Recognised as the world's largest line and network agnostic serialization software solution, SSM bridges the gap between corporate IT systems (MES, ERP, etc.) and the shop floor, forming part of Vimachem's broader Digital Factory suite. It supports compliance with global serialization regulations including DSCSA, Anvisa, and EU FMD, and is currently deployed across 30 countries, interfacing with over 900 packaging lines from more than 10 serialization line vendors.

SSM is the only Level 3 solution on the market designed and developed in direct collaboration with Tracelink. Its adaptive interface technology enables plug-and-produce integration with any Level 2 line or network system and any corporate Level 4 system, delivering a best-of-breed serialization approach that avoids vendor lock-in and slow reaction times associated with single-vendor solutions. The platform is classified as a GAMP 5, Category 4 Configured Product, consisting of standardised modules and documentation packages that can be assembled and realigned to accommodate changing operational demands.

Core Software Modules

• Master Data Module – centralised management of product master data across the serialization environment
• Rework Module – supports rework processes within serialization workflows
• Label Design Module – design, manage, and version-control label and format layouts
• Article Management Module – manage article configurations and serialization parameters
• Manufacturing Analytics & OEE Module – monitor and improve overall equipment effectiveness for packaging lines
• Serialization Warehouse Module – extends serialization and aggregation capabilities into warehouse operations
• Packaging Scheduler Module – powered by machine learning algorithms to optimise packaging order scheduling

Key Benefits

• Time Reduction – reduced time to prepare and start production runs
• Error-Free Packaging – elimination of incorrectly coded and packaged products by identifying all errors during testing before actual production runs
• Continuous Production Flow – minimised unscheduled line stoppages
• Global Serialization Compliance – full compliance with DSCSA, Anvisa, EU FMD, and other global serialization requirements
• Increased Production Output & Packaging OEE – parallel assignment and execution of steps across users to streamline team workflows

Demonstrated Operational Results

• 25% increase in serialization systems Overall Equipment Effectiveness (OEE)
• 65% reduction in serialization-related quality deviations
• 15% faster order completion

L4 and L5 System Integration Features

• Tracelink Collaboration – all daily serialization operations, including commissioning and sending data to marketing authorisation holders, can be performed directly from the SSM user interface while Tracelink operates in the backend, enabling internal teams to use a single software system for daily operations
• Automatic Data Transfer & Verification – automatic transfer of product master data, aggregation hierarchies, serial numbers, and more between SSM and Tracelink, with verification according to Annex 11 Section 5, reducing manual input errors, setup time, and line downtime
• L4 Interface Based on EPCIS Messages – standardised electronic product code information services messaging for L4 connectivity
• Product Master Data Import & Update – supports import and update via SAP iDOC XML, SOAP, or CSV file formats
• Flexible Production/Process Order Creation – order creation with or without Material Master Data using SAP iDOC XML or SOAP
• Custom Integrations – additional custom SAP and Arvato integrations available per customer requirements

L2 System Integration Features

• Elimination of Machine Downtime – label and format design management, including retrieval of existing layouts from packaging lines or tools such as Nicelabel and Codesoft, with version control and publishing, eliminates downtime caused by on-floor layout design
• Complete Audit Log Retrieval & Merging – full audit log retrieval covering rejection reasons, camera grading, and machine alarms, merged with the L3 audit log to produce a single combined L1–L3 audit log
• Remote Serialization Machine Management – VNC/Remote Line HMI within SSM enables remote management of serialization machines directly from the SSM interface
• Configurable L2–L3 Interface – supports pause and resume across different lines, parallel production of different batches in serialization and aggregation machines, and other custom workflows
• Real-Time & Offline Line Monitoring – real-time monitoring of counts and rejections, with the ability to interface an L2 system without a live connection depending on the L2
• Order Queuing – scheduling of packaging orders within SSM with automatic loading onto serialization machines in a pre-defined sequence, with one order loaded per machine at a time
• Validated Line Simulator – a validated software line simulator enables end-to-end testing with supply chain partners without requiring physical packaging machines

Available L3 Services

• Level 3 Installation, Validation Execution & Project Management – end-to-end serialization track-and-trace support delivered by expert consultants to achieve cost-effective compliance
• Level 3 Qualification Documentation and Validation Plan – comprehensive validation services aligned with GAMP 5 risk-based methodology, including risk assessments, qualifications, test cases, traceability matrices, and technical documentation
• Level 3 Annual Support – ongoing support covering software updates, compliance upgrades, remote troubleshooting, issue resolution, and SLA-backed technical assistance

Vimachem SSM is supported by 24/7 global support teams located across three regions — USA, Europe, and Asia — and integrates with leading serialization line vendors including Wipotec-OCS, Antares, Optel, Seavision, Seidenader, Mettler-Toledo/PCE, and Scanware, among others. The platform also connects with corporate systems from Tracelink, SAP, Arvato, rfxcel, and Verify Brand, making it a highly interoperable solution for pharmaceutical manufacturers operating in complex, multi-vendor environments.