Businesses are dynamic, and disruptions aren’t the exception – they are the rule.
Think about all the change happening within your company on a given month: You might bring on a new executive, lauch a new product, switch vendors, lose and hire new employees, or expand into a new market. Navigating some of these situations requires the ability to improvise, but others demand preparation.
DSCSA serialization compliance – a cross-functional and multi-layered undertaking – falls firmly into the latter category. Imagine how any of these unexpected obstacles would impact your compliance project:
- Your operations manager quits, leaving you without their accumulated knowledge and planning, and a void of valuable resoures
- You acquire a new facility that now requires you to merge two serialization efforts into one
- A new CMO is contracted and needs to be engaged in the process
- An IT system critical to your implementation effort is due for an upgrading
Curve balls like these are real, and they can compromise your project, if not paralyze it. Many of our consulting engagements grow and change over time – for instance, we’re currently on our ninth statement of work for one client, executing a road map that was first defined by us three years ago. In those three years, many things have changed, but the project is on solid foundation and stronger than ever.
How do you protect yourself from these business eventualities? The short answer is vision, methodology, and continuity. Organizations with successful implementations establish clearly defined roles, follow comprehensive and proven roadmaps, and maintain detailed records from the first step to the last. That’s exactly what LSPediA’s Serialization Toolkit provides, and – with complete contingency strategies and access to our deep industry knowledge – it keeps you on track when faced with unforeseen circumstances.
A Scalable, Customizable Solution that’s Delivering Real-World Success
Through the Serialization Toolkit, we establish and follow a four-step serialization preparation and implementation process for every client:
- Awareness – Uncover how serialization will impact every part of your business, inside and out
- Understanding – Ensure all staff and vendors are aware of their roles and responsibilities
- Expertise – Educate every member of your serialization team as a subject matter expert and enable them to be successful in their role
- Contribute – Monitor and engage with stakeholders to ensure tasks are completed as assigned and on time
But we also know that every organization is unique, so we designed the Toolkit to adjust to any environment, and scale to any growth. No matter the size, location, or needs of your business, we give you the tools and services you need to succeed across the serialization implementation spectrum:
- Regulations and Impact Analysis
- Strategy: Gap Analysis, Roadmaping, IT Infrastructure
- Packaging: Label Templates, Serialization Master Data, Packaging Guide
- Line Execution: Implementation and Project Plans, SOPs
- CMOs: GTIN and Numbers Management, CMO Spec, Compliance Checklist
- Training: In Person, Webinars, Online and Video
The LSPediA Toolkit is a comprehensive set of serialization instructions, letting you know what has happened in the past, what is happening at any moment, and what will happen in the future.
Simplify Serialization, With the LSPediA Toolkit
Working with LSPediA and deploying our Serialization Toolkit will ensure that your business can:
- Lower overall serialization spending by reducing the number of redesigns
- Mitigate compliance risks and reduce recallswith comprehensive, gapless coverage tailored to your specific needs
- Shorten your project timeline by removing trial-and-error process
To get your organization equipped, trained, and prepared to carry out a serialization implementation plan, contact me today. We’ll discuss how we can customize a toolkit that fits your organization’s needs.
LSPediA helps pharmaceutical manufacturers and distributors implement serialization and aggregation processes to meet global regulations, DSCSA requirements, and future track-and-trace mandates. Our services include URS, RFQ, gap analysis, serialization toolkits and solutions, DSCSA strategies, management consulting, and more.
We value long-term relationships and work with our clients’ internal teams to properly define roadmaps, create architectures, and implement systems that align to vital business goals, ultimately helping them derive maximum value from their investments, both now and well into the future.