Imagine you’re an operations manager at a mid-sized pharmaceutical manufacturer. The executive team has given you the responsibility for ensuring the company complies with the new serialization requirements mandated by the Drug Supply Chain Security Act (DSCSA). It’s a daunting task: You have no serialization experts to turn to within the company, a tight timeline, a limited budget, and there’s a lot at stake – including patient safety, your company’s reputation, and potential non-compliance penalties.
But you find a solution. Instead of hiring an expensive consulting-firm task force, you tackle the job yourself by deploying a customizable toolkit that guides the entire organization through the process – with the help of an industry expert. From analysis and road mapping, through training and site/line execution, your company meets every deadline and requirement, on time and on budget. That means the executive team is impressed, your company gains a competitive advantage, and patients have peace of mind.
LSPediA’s Serialization Toolkit can help your company achieve these same goals. Having worked on countless line executions, and with a deep understanding of the complexities of serialization and traceability, we’re already helping drug manufacturers, packagers, and distributors prepare for the big changes brought about by the DSCSA.
DSCSA Serialization Requirements are Changing Everything
By November 27, 2017:
- Pharmaceutical transaction information must beprovided electronically – paper-based information will not be accepted
- Drug products must be imprinted or affixed withproduct identifiers at the unit and case level
This is not a simple undertaking. New FDA rules and processes will impact your entire organization, including IT, R&D, inventory, operations, supply chain, and distribution, as well as how you interact with partners and vendors.
The 2017 serialization mandates are just one step in a process that is reshaping – for the better – how the pharmaceutical industry operates, with the ultimate goal of unit-level traceability in 2023. How well your company meets these requirements now will have a serious impact on how well you meet future DSCSA requirements.
It’s crucial to invest in a comprehensive solution that ensures scalability, can be customized to meet specific needs within
your organization, and is backed up by an industry professional who can answer your questions and serve your needs.
Simplify Serialization, With the LSPediA Toolkit
The LSPediA Serialization Toolkit is built on industry best practices and can be deployed at your organization as a customizable template, regardless of which country you operate in. That means every stakeholder in every line of business can be equipped, trained, and prepared to implement a serialization process within your company.
How you benefit:
- Lower overall serialization spending by reducing the number of redesigns – the Serialization Toolkit ensures you get it right the first time
- Mitigate compliance risksand reduce recalls with comprehensive, gapless coverage tailored to your specific needs
- Shorten your project timeline by removing trial-and-error process
If you want smarter implementation, faster onboarding, and complete control of your serialization effort, contact me today. We’ll discuss how we can customize a toolkit that fits your organization’s needs.
“We were able to work with LSPediA in order to successfully complete our serialization and DQSA project for the 2015 launch. Currently we are working with LSPediA on 2017 serialization requirements and ERP which is absolutely critical to our business.”