In Part One of this series, I talked about the challenges and limitations of document-based storage. It’s clear that while this method has been a cornerstone of business data management for years, it’s increasingly becoming a hindrance, especially when we look at how rapidly industries are evolving. (Another reason not to fall into the trap of “this is how we’ve always done it!)
But what’s the solution?
Enter object-based storage- a powerful, scalable, and more efficient alternative that’s not only changing how businesses manage their data but also transforming their ability to meet regulatory requirements, innovate, and adapt to an ever-changing landscape.
In this blog I’ll talk you through how object-based storage works, why it’s superior to document-based systems, and how it can streamline your business operations – saving you time, money, and resources (not to mention headaches when regulatory bodies come calling!) in the process.
The Domino Effect: Why One Change Leads to Many
When you make a change in a document-based system, it’s a little like trying to move a single puzzle piece – but the entire puzzle shifts in unexpected ways. For example, in regulated industries like medical devices or pharmaceuticals, each regulatory requirement has a ripple effect throughout the lifecycle of the product. As one piece changes – whether it’s in design, manufacturing, or associated documentation- it can require updating numerous documents, processes, and systems. This domino effect makes tracking changes cumbersome, not to mention error-prone.
With object-based storage, this issue is essentially eliminated. Object-based systems are inherently flexible, meaning that when you change a data point, the system is designed to update and link all dependent data in real-time. This approach provides better visibility, reduces redundancy, and makes sure that all updates are captured in a way that complies with regulations. Instead of manually updating multiple files or documents, you can track changes across a network of connected data points – automatically.
The Importance of Interconnection
In industries like medical devices, where lifecycle management is paramount, object-based storage shines. Each step in the lifecycle, from initial design and development, to regulatory submission and post-market surveillance,generates data that needs to be properly tracked, documented, and stored. Traditionally, this information would be kept in silos, often requiring a lot of manual intervention to connect the dots.
But with object-based storage, everything is linked. When a change happens- whether it’s a design modification, manufacturing adjustment, or regulatory update- the object-based system automatically updates all associated data, ensuring that nothing is overlooked and that all documentation continues to meet regulatory requirements.
For example, a regulatory submission for a medical device is a snapshot of premarket data. If any premarket elements change, such as adjustments to the design or labeling, the system can flag the change and determine if a resubmission is necessary. The interconnected nature of object-based storage allows this to happen seamlessly, eliminating the need to manually check every document and file for consistency.
Linkable, Searchable, and Changeable
Object-based storage isn’t just about storing documents; it’s about creating a single source of truth and making it dynamic and connected. One of the key advantages is that data is now linkable, searchable, and changeable in ways that simply aren’t possible with traditional document storage.
For example, in industries that require precision, like aerospace or medical devices, design files, CAD specifications, and 3D modeling are critical. In an object-based storage system, these files are stored as objects, with an inherent ability to link them to other data points in real time. Need to find design files for a product? No problem. Simply search for the object, and you’ll be able to access not only the design itself but also any linked information, including audit trails, specifications, and regulatory submissions.
Additionally, with an object-based system, you don’t have to worry about outdated or incomplete information. Changes are automatically tracked and recorded, creating an unbroken audit trail. Who made the change? When was it made? What was changed? This level of transparency is invaluable, especially when it comes to compliance audits.
Moving from Paper to Digitalization
One of the biggest issues with document-based storage is the sheer amount of physical space it takes up. The number of documents that need to be stored, tracked, and updated is overwhelming, especially when you consider the complexity of managing compliance in regulated industries.
Now, imagine eliminating most of that physical storage and moving all that data into a digital system that is scalable and easy to update. That’s the promise of object-based storage. Instead of simply digitizing a piece of paper into a PDF, object-based systems digitally bring data to life. It connects and integrates systems, making it easier to find, change, and track the data you need without the hassle of maintaining physical documents.
This shift from traditional document management to digitalization is especially important as industries like medical devices, pharmaceuticals, and aerospace face increased pressure to innovate and adapt quickly. The reality is that medical devices are not getting simpler – in fact, the regulatory process is becoming more complex. But object-based storage can help simplify the management of that complexity by allowing you to easily track and manage data, ensuring compliance while also driving innovation.
Regulatory Requirements and the Need for Change Control
In regulated industries, the need for change control is a constant. Every design enhancement, manufacturing adjustment, or labeling change has to be tracked and documented. With traditional document-based systems, managing this level of detail can quickly become overwhelming.
Object-based storage, on the other hand, allows businesses to automate the tracking of changes across all their systems, ensuring that everything is aligned and compliant with regulatory requirements. From an audit trail to linking data points to regulatory submissions, object-based storage provides a more comprehensive, streamlined approach to managing change.
This shift isn’t just about being more efficient- it’s about being more proactive. With change control and audit trails built into the system, you can stay ahead of potential issues and stay focused on growing your business while maintaining compliance.
What’s Next: Moving Toward Interconnection and Integration
As we move into an era of smarter, more efficient data management, the next step is clear: interconnection and integration. Object-based storage doesn’t just store documents- it integrates them into a broader network of interconnected data. This shift not only saves time and reduces errors, but it also empowers businesses to make better, more informed decisions.
For businesses in regulated industries, like medical devices or pharmaceuticals, this transition is a game-changer. It’s time to move from siloed systems and paper-based workflows to interconnected, dynamic data networks. The result? Better care, smarter decisions, and more effective regulatory compliance.
The future of business and compliance is clear: it’s digital, dynamic, and interconnected. If your organization is still relying on outdated document-based systems, it’s time to start thinking about the next step. By embracing object-based storage, you can transform your data management, improve efficiency, and keep your business on the cutting edge of innovation.
In Part Three of this series, I’ll dive into the actionable steps to help you implement object-based storage in your organization. From understanding the resources you need to sell the concept internally to exploring the best software solutions available, I’ll break down everything you need to get started.
If you have questions – and with a topic this revolutionary, I’m sure you do! – connect with me and we’ll talk through it.
And of course, stay tuned for the final piece where we make it all come together!