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Dude, Where’s Your Product Data?

 

As a medical device manufacturer, your data is quite important every time the regulatory bodies request a product audit trail for review.

How important is your data to you? How do you manage your data today? Who checks whether your data is updated?

Most companies that I talk to are struggling with these questions.

More specifically, they are struggling with capturing every change and every decision being made to a product and its related project folder, data, and documents throughout the product’s entire life cycle.

This is often being managed manually through different folder structures, containing different project versions. All controlled through a manual change process. This method has a high level of risk associated with it as it relies on human actions to place the correct data in the correct place with no automated audit trail from one version to another.

This practice results in a lack of traceability, forcing companies to manually build an audit trail each and every time the regulatory bodies request it.

Given the levels of risk and fines, it seems likely that companies need to know where their product data is and where they stand in relation to data management.

  

Why do we still use this practice?

We live in a world where the Internet of Things (IoT) is present in nearly every product we use in our daily lives. Data and especially big data are now considered a commodity, as valuable as oil and gas (or, even more).

That is why I cannot understand why we keep managing our valuable data in spreadsheets and manually operated documents? We all know the importance of complying with the demands for traceability, set by the regulatory bodies.

Most of us are aware of the potential benefits that are associated with an automated document workflow.

 So, why do we continue with this rather careless practice?

That is why we developed Minerva PLM

In Minerva PLM, you are able to streamline this process as data and associated processes are managed and controlled together in the same system.

With its ability to help organize disparate information, and capabilities, Minerva PLM has huge potential to add benefit at the beginning of life-phase (BOL), including: 

  • Design and manufacturing, with the initial conceptualization, development, and prototypes built.
  • The initial phase has multiple sub-actions that identify all the requirements, concepts, and necessary testing, which also includes specifications, production process, and supply needs.

Looking at the middle of life-phase (MOL), Minerva PLM also enables all stakeholders in a product’s life cycle to see how the product is performing and how it’s being used in real-time, without waiting for customers to report on it. This means you can:

  • Collect data on any failures, maintenance, and user experience to get information for immediate fixes and future development.


In this video, I will show you how you can handle these document structures in the same way with the same requirements for change management and traceability and achieve:

  • Accurate project update status Faster documentation retrieval and more assured regulatory compliance by capturing product data as it happens, not as an afterthought
  • Risk avoidance
  • Efficient regulatory submission workflow that is futureproofed. Face an audit with confidence knowing that information is held or federated into a single knowledgebase, readily available
  • Decreased risk of errors and improved product quality and support with the ability to rapidly respond to changing customer demands.

About the author

Thomas Skogen

Thomas is an expert in Supply Chain and Manufacturing Optimization with more than 10 years of experience originating from Medical Device and High-Tech & Electronic Industries. He comes with a background as an Electronics engineer, complemented with a Master in Technology Management. Thomas has held positions in multinational corporations such as Nilfisk, heading the internal optimization program as well as the supply chain organization.

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