We use cookies to help you navigate efficiently and perform certain functions. You will find detailed information about all cookies under each consent category below.
The cookies that are categorized as "Necessary" are stored on your browser as they are essential for enabling the basic functionalities of the site. ...
Necessary cookies are required to enable the basic features of this site, such as providing secure log-in or adjusting your consent preferences. These cookies do not store any personally identifiable data.
Functional cookies help perform certain functionalities like sharing the content of the website on social media platforms, collecting feedback, and other third-party features.
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics such as the number of visitors, bounce rate, traffic source, etc.
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Advertisement cookies are used to provide visitors with customized advertisements based on the pages you visited previously and to analyze the effectiveness of the ad campaigns.
In today’s dynamic pharmaceutical industry, Contract Manufacturing Organization (CMOs) face increasing pressure to ensure the authenticity, safety, and full traceability of every product released to the market. A robust Pharma CMO Track and Trace solution is essential—not only for meeting stringent regulatory requirements but also for enhancing supply chain visibility, preventing counterfeiting, and ultimately safeguarding patient safety. Hicof’s high‑performance machines and software, combined with the innovative AMACENA Software, deliver an integrated, cloud‑based solution designed specifically for CMOs.
Contract Manufacturing Organizations (CMOs) play a vital role in the pharmaceutical industry by ensuring the efficient and compliant production of medicines. Responsible for manufacturing and packaging, CMOs must adhere to stringent regulatory requirements while maintaining the highest quality standards. In an industry where counterfeiting and evolving regulations present ongoing challenges, CMOs must implement advanced technologies to ensure product integrity throughout the supply chain.
Pharma CMO Track & Trace solutions provide seamless serialization and aggregation, enabling full compliance with global regulatory standards. Hicof’s solution is built on high-performance machines and intelligent software, designed to integrate smoothly into existing production lines. Engineered with Swiss precision, our system simplifies serialization without the complexity of managing multiple components—ensuring CMOs can meet their clients’ demands while maintaining operational efficiency.
Regulatory bodies across the globe—including the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA)—demand rigorous serialization and track & trace measures. A compliant Pharma CMO Track & Trace solution ensures:
A sophisticated track & trace system is essential for ensuring compliance and maintaining the integrity of pharmaceutical production. With real-time monitoring and seamless data integration, CMOs benefit from:
Seamless Compliance: Ensuring every serialized unit meets global regulatory requirements without disrupting production efficiency.
Optimized Production: Real-time tracking enhances batch control and minimizes delays in packaging and distribution.
Operational Efficiency: Integrated monitoring streamlines serialization and aggregation, reducing errors and rework.
Beyond compliance and security, a comprehensive Pharma CMO Track and Trace system enhances manufacturing efficiency:
Precision Automation: Automated serialization and aggregation reduce manual intervention, ensuring accuracy and speed.
Production Optimization: Streamlined workflows and minimized rework improve overall manufacturing efficiency.
The Amacoder delivers a very high coding quality as shown in the image.
The reason for this high coding quality is as follows:
Hicof is recognized for its cutting‑edge solutions in pharmaceutical serialization. Our high‑performance machines and software are designed to work together seamlessly, providing Contract Manufacturing Organizations with unmatched reliability and efficiency.
Unlike solutions that rely on disparate systems, Hicof’s machines and software are developed in-house. This integrated approach means:
Every element of our system is 100% designed and built in Switzerland—a country renowned for its precision engineering and rigorous quality standards. This commitment to Swiss manufacturing ensures that:
At the core of our Pharma CMO Track & Trace solution is the innovative AMACENA Software — a cloud‑based platform designed to revolutionize how serialization data is managed and utilized.
AMACENA is built from the ground up for the cloud, offering a host of benefits:
One of AMACENA’s standout features is its robust 4‑eye principle change process. This critical security measure requires any changes to serialization‑relevant data to be reviewed and approved by two authorized users. Benefits include:
User experience is a top priority for AMACENA:
Implementing a comprehensive Pharma CMO Track & Trace solution like Hicof’s brings a multitude of advantages for CMOs:
Automated Compliance: Seamless integration ensures serialized data is correctly formatted for regulatory submissions.
Audit-Ready Processes: Every serialization action is logged, ensuring full traceability and compliance oversight.
Global Standards Alignment: Regular updates keep production in line with evolving regulatory requirements.
End-to-End Traceability: Every serialized unit is accurately tracked throughout the manufacturing and packaging process.
Product Integrity Assurance: Secure serialization and aggregation measures prevent mix-ups and unauthorized product movement.
Real-Time Quality Control: Continuous monitoring detects and addresses anomalies before they impact production.
Precision & Quality: High-accuracy label printing and serialization ensure compliance and reliability in production.
Operational Transparency: Detailed tracking and reporting enhance visibility across manufacturing and packaging processes.
Secure Data Management: Advanced encryption and controlled access safeguard serialization data and regulatory records.
Hicof AMACENA features a build-in web based label creator to create and adjust all print layouts for AMACODERS, and all connected tertiary label printers. The label creator allows GMP compliant change control of all label parameters across the enterprise.
To fully leverage the benefits of Hicof’s Pharma CMO Track & Trace solution, a structured implementation process is key. Here’s a step‑by‑step guide to ensure successful deployment:
The HICOF Machines offer in combination with AMACENA an integrated IT-backbone, starting at machine level from the devices as printers, cameras and sensors up to data interfaces of governmental servers. In case of an issue, our experts have instantaneously access through remote access to all relevant parameters across all IT-servers down to the PLC, allowing a seamless and immediate support. This is the opposite of the conventional ISA-95 environment with several software and machine suppliers in which each service engineer has only access to his fraction of data, making a comprehensive root cause analysis extremely cumbersome as he has to synchronize with other involved vendors.
Hicof solves the issue by offering
One System, One Supplier, One Responsibility!
