With FDA DSCSA and EU FMD deadlines passing and others quickly approaching, many companies need to implement and operate Project Management Offices for their pharmaceutical and health science supply chains. Manufacturers, distributors, hospitals, repackagers, and pharmacies are required to set up a track and trace system around their products to ensure they have interoperable programs in place leading up to 2023.
Track & Trace Project Management
Are you in health sciences and need to select and implement a product traceability system?
At Ten Count, our Project Management service can be tailored for a portion or an entire organization for supply chain serialization and product traceability. By engaging with our DSCSA consulting services, clients have the ability to bridge interdepartmental gaps between plants, IT, engineering, packaging, supply chain, quality, and commercial departments and trading partners to successfully implement solutions.
PMO Development
Tools & Methods
Workshop and Meeting Facilitation
Risk and Issue Management
Program Status Reporting
Assessment
We define the scope, critical path, budget, and DSCSA readiness according to your company’s role in the life sciences supply chain (brand owner, CMO, Distributor, Repackager, Dispenser.)
Systems Blueprinting
We architect detailed business requirements, gaps, and risks related to the project. Then we manage and procure trading partners to service the required systems implementation and serialization solutions.
Training and Orientation
We establish and educate an internal and cross-functional serialization team. We provide educational material, online and onsite training sessions for your internal serialization team.
Testing and Validation
We support your team in confirming the impacted systems are configured, functioning, connected and interoperable with all your trading partners. Our global testing and international experience allow us to ask questions other consultants may miss.
Execution and Launch
We ensure readiness, cutover, and go-live of all systems and processes. This means we are a part of every stage of implementation and do everything to make sure your team is prepared with emerging technologies.
Reporting and Controlling
We monitor ongoing system maintenance and reporting in place to ensure continuity of environments, data and audit readiness. This includes monthly reports and status updates to ensure adherence to compliance.