What does the Drug Supply Chain Security Act (DSCSA) mean for Life Sciences ERP Implementations?
The world of regulatory and compliance is ever evolving as both the demand for controls and the ability of technology to provide them impact the market. For wholesale distributors (including 3PLs), packagers (including CPOs), manufacturers (including CMOs), and dispensers, this means that their organizations must stay on track and within the timelines set forth by the FDA. With respect to the requirements set forth in the Drug Supply Chain Security Act (DSCSA), compliance began in 2015 and will continue to be phased in through 2023.
Any ERP implementation that touches functions where the DSCSA requirements are relevant must take into account not only the current requirements but also future phasing and their relationship to the ERP implementation timeline. Key considerations:
Life Sciences companies typically have supply chain and distribution partners. Are your partners compliant and able to share data as required?
What will be the "system of record" for the data elements? Often a partner's system can fulfill this role, meaning that data such as serial numbers do not necessarily need be replicated in the ERP system.
Physical product labeling is a key component to compliance. Architecting a system that has an efficient data flow, that supports, rather than hinders, a manufacturing or distribution process is part of the data.
Integrations take time to design and develop but are necessary for compliance and an overall well-functioning IT Ecosystem. For project timeline, resource allocation, and budget purposes, the integrations need to be considered. Integrations include internal with the labeling system and ERP as well as external with 3rd Party partners such as CMOs, CPOs, 3PLs, and Track & Trace systems.
Solution Architecture is the most important part of this ERP Implementation. Having an understanding of how the FDA requirements, how the 3rd party partners operate, and the capabilities of the ERP system all must be drawn from in order to properly design a solution from the early stages of the project. Timelines can be greatly impacted if a redesign is necessary in a later phase of the project.
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