LSPediA helps pharmaceutical manufacturers and distributors plan, design, and implement processes and solution to meet serialization global regulations, DSCSA requirements, and future track-and-trace mandates. Our services include serialization gap analysis, strategic planning, solution architecture, vendor selection, line execution, CMO management, supplier management, implementation, and more.
At the strategy planning stage, LSPediA helps our clients assess the risks, benefits, and impacts of serialization to determine the project’s priority. While collaborating with the functional groups, customers, suppliers, and trading partners, requirements are consolidated, gaps are identified, and an effective roadmap is created. The strategy planning service encompasses the following:
- Gap analysis
- Findings and recommendations
- DSCSA Serialization Planning
- DSCSA Serialization architecture and roadmap
- Project execution plan
This critical service delivers a roadmap and a detailed project plan to simplify and streamline the implementation.
Technology venders play an important role in the DSCSA Serialization project. LSPediA helps our clients make better informed decisions choosing the right vendor that will meet DSCSA Serialization requirement now, in 2017, and into 2023 and beyond. The vendor selection service entails the following activities:
- Vendor communications
- Build and manage core team
- Request For Quote (RFQ)
- Vendor evaluations
- Demo process and script
- Vendor audit
- Contract review and negotiation
The DSCSA Serialization project not only requires major investment in facilities, equipment, and technologies but also demands substantial resources to implement them. With deep domain expertise and decades of experience, LSPediA offer system integration services to help companies succeed in serialization implementation.
LSPediA provides a thorough, risk-based approach to computer system validation that meets the requirements of FDA CFR21 Part 11 and EudraLex V4 Annex 11. Our validation service encompasses:
- Validation planning
- Developing master plan, risk assessment, etc.
- Review and tailor IQ/OQ/PQ
- Executing IQ/OQ/PQ
- Managing issues and deviations
With increased demand on time, resources, and budget, proper project management is necessary to minimize the risks and maximize resource utilization. LSPediA offers project management service to help execute the implementation plan with discipline. This service is scoped to:
- Build and manage the core team
- Execute the strategic plan
- Create and maintain the project plan
- Allocate resources
- Manage schedules
LSPediA offers CMO management service to on board your CMOs into your DSCSA Serialization framework. The CMO service is designed to:
- CMO communications
- Define goals, scope, and responsibilities
- Create specifications, roadmap, and project plans
- Define deliverable and action items
- Track project and resolve issues
- Implement data exchange and integration
LSPediA develops a clear cut, thorough process that helps a company our size easily define our goals, then work to implement them. I would have no issue to recommending LSpediA to be the project leader in the implementation of DSCSA and Serialization.
A Pharmaceutical Customer
We don’t have a staff large enough with the sufficient knowledge and experience to take on a serialization project on our own, so we utilized LSPediA’s knowledge and now we basically have the workforce and knowledge of a much larger company because of it. It has been a really great relationship.
A Pharmaceutical Customer