SERIALIZATION (TRACK & TRACE)
Fulfilling the increasing regulatory requirements for patient safety.
We have been supporting Pharmaceutical companies in implementing Serialization (Track & Trace) programs and projects for over 10 years. Our services enable our customers in fast & efficient implementation of process changes and technologies across all levels – from packaging shop floor, over centralized repositories, up to interfacing to governmental databases – into their business thereby avoiding the costly learning curves and limiting risks through proven methodologies, tools, template packages and our deep expertise. While we can help in choosing the right technology partners, we see the crucial success factor in a proper methodology for implementation, process change and system life cycle management.
- Market knowledge and regular engagement with technology and solution suppliers
- Understanding of full picture on integrated solutions across all implementation levels, combined with processes that are using them
- Knowledge of regulations through GS1 interaction & public policy reviews
- Business requirements through analyses with industry management teams
- Development of operational processes and business use cases in conjunction with key stakeholders
- Methodology-based project and quality management throughout implementation and lifecycle in both, global and site-based capacities
- Best practice management for ongoing support and continuous improvement