With an increasing complexity in the pharmaceutical serialization regulation and supply chain requirements across the globe, project management has become an integral part of the pharmaceutical companies to manage their track & trace projects in an effective and efficient manner.
Implementation of Project Management in an organization creates a strategic value chain by aligning the business goals and managing schedule, budget, quality, resources, and risks associated with it that gives companies an edge on their competitors.
According to the Project Management Institute (PMI), organizations that undervalue Project Management report wasting 11.4% of every dollar spent due to poor project performance and an average of 50% of their projects failing outright.
Pharmaceutical companies need to build a robust system for Serialization Project Management not only to manage the activities of different L1-L5 partners involved but also to ensure that the internal workstreams like labeling, validation, change management, IT infrastructure, plant sites, etc. are managed and the risks associated with them are constantly reviewed, discussed, and mitigated.
Importance of Serialization Project Management
Serialization Project Management follows the process of initiating, planning, executing, controlling, and closing the work as per the milestones defined in the Project Charter and Project Plan. The entire process flow will help a pharmaceutical company to launch their serialized products to the market without any delay and ensuring good quality and reduced overall project costs at the same time.
In addition to stimulating productivity, improving project transparency, and providing a clear vision to the team, there are other advantages of having a Serialization Project Management team to manage the end-to-end project as listed below:
- Outlines clear objectives
- Establishes well defined IPP (Integrated Project Plan)
- Creates change management plan
- Creates focused communication plan
- Establishes Risk Management plan
- Monitors schedule, cost & quality management plans
- Maximizes resource utilization to ensure higher productivity
How can CosmoTrace help?
Supporting you in your serialization journey
With our experience of working with small, medium & large size pharmaceutical companies across the globe and implementing complex systems like SAP, TraceLink, Arvato to name a few, We can run projects from consulting through implementation to on-going support, leveraging proven methodologies and adhering to superior quality standards. Our focus is on delivering the absolute best serialization support by offering long-term serialization and sustainability strategies and providing forward-thinking industry solutions. We have seasoned project managers to help you strategize and establish end-to-end Serialization Project Management tools in place.
Adhering to global serialization standards
We work closely with government bodies responsible for creating anti-counterfeiting and compliance legislation across the globe and have successfully implemented projects for EU FMD, US DSCSA, RUSSIA, CHINA, and Middle East geographies. We are well versed with the compliance regulations for various markets and can help you with the end-to-end implementation of serialization requirements as per your unique processes and target markets.
Need a helping hand in ensuring smooth operations in your serialization efforts. Contact us to get started.