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Analyzing Best Practices in Lean Labeling for Global Efficiency & Regulatory Compliance

By Tim Fischer

Last week (29th & 30th September), over 40 speakers from across the medical device industry came together to discuss the latest trends, issues and best practices in optimizing medical technology labeling and packaging.

5th Semi-Annual Medical Device Labeling & Packaging Conference
5th Semi-Annual Medical Device Labeling & Packaging Conference

We were pleased to take part in the 5th Semi-Annual Medical Device Labeling & Packaging Conference where, through both a highly interactive presentation and workshop, we were able to delve into some of the best practice theory and learnings from international manufacturing processes; learnings that underpin our approach to effective, end-to-end label lifecycle management.

With an international regulatory and competitive environment that is evolving at an unprecedented rate whilst also becoming increasingly complex, medical device manufacturers still face many challenges in optimizing their operations. Whether that is preparing for UDI compliance; ensuring centralized control over a complex supply chain; local language labeling efficiency; or even ensuring speed to market with new a product launch, in many cases the role of the label (and the negative impact of an inefficient process) is not fully understood.

PRISYM ID puts validation at the core of all our projects, which as well as being an FDA requirement is also a fundamental principle of the Lean approach to manufacturing. At its core, Lean labeling is about understanding all the inputs to the labeling process and understanding them well enough to be able to predict the outputs of that process – minimizing inconsistency, overburdening and waste.

PRISYM ID’s validation team supports our clients in fully scoping the User Requirement Specification (URS) according to the GAMP V model, which is designed to help organizations define how to address the FDA’s 21 CFR Part 11 – which outlines a requirement for software control and validation. By ensuring that all user requirements – from the supplier all the way up through the supply chain to the end customer (ie the patient) – are fully understood, the labeling system can then be implemented to ensure full centralized control.

Manual or disparate software systems can simply no longer meet the needs of medical device manufacturers today. From UDI to destination labeling and international product launches, every part of the process is impacted by the label. We are now seeing the most forward-thinking companies recognize this.

As such, we welcome events such as the 5th Semi-Annual Medical Device Labeling & Packaging Conference as providing the platform for informed and engaging discussions around topics such as validation to help the industry adopt the best practices required to succeed moving forward.

Download Analyzing opportunities in LEAN labeling programs and technology presentation

Read our blog post: Designing a Global Labeling Strategy, Given the Volatility of the Regulatory Climate

About the author:

tim-fischerTim has spent over 25 years in and around Life Science compliance. Having launched his career at Abbott Labs in the Hospital Products Division in North Chicago, he spent most of his early days within Biological QA/QC as well as Small Volume Parenteral operations management. He then did additional technical work.

Following his Abbott days, he worked as Director of Compliance for 3 CMOs and in 2007 decided to strike out and perform 21 CFR 820 quality system consulting. It was during this period that he developed an appreciation for compliance software of which he has been heavily involved in over the course of 6 years including with PRISYM ID.