spk-logo-white-text-short2
0%
1-888-310-4540 (main) / 1-888-707-6150 (support) info@spkaa.com
Select Page

How PLM Enables Innovation Without Risking Compliance

As technology has advanced, it’s become more complex — and with complexity comes the issue of tracking and monitoring the different processes and their corresponding data. In non-critical applications, the extent of this reporting is often minimal.

However, in industries such as the medical device or the aeronautic industry, collating and managing the data produced from the different stages and processes involved in developing a product is essential. Since these industries build products which need to be safe, robust and reliable, it is mandatory for compliance purposes that all product-related knowledge and information is collated, processed and managed.

This need to generate and maintain large amounts of product-related data can be burdensome on the development process, however. If a manual or ad-hoc process for generating compliance data is used, then innovation will be stifled or key data will be lost as executing the process of data gathering becomes difficult and ultimately ignored.

The success of any process is directly linked to the ease of its use. Once a process becomes an obstacle to productivity, mistakes (intentional or unintentional) will be made as engineers strive to save time.

The solution to enabling engineers to design, develop and innovate and yet store and manage the knowledge, processes and data needed for regulatory compliance is to implement a Product Lifecycle Management strategy.

PLM is an information driven strategy which allows organizations to create, develop, deliver, support and retire products. By using integrated tools and a central repository for all product related information, this process captures all the knowledge, decisions and information generated throughout a product’s entire lifecycle.

Because it is integrated and provides tools for use at every stage of the product’s lifecycle, this approach removes the burden of compliance data gathering and ensures that all the key information is captured from the different and separate stages of the products creation, from conception to retirement.

As a development model, PLM integrates the people, the data, the processes, and the business into a product-related information backbone. From this information; store management, design and engineering decisions can be made based on what has happened previously in the product lifecycle but also based on the knowledge acquired in the creation of other products in the business. Simultaneously, compliance data is available for submission to the appropriate regulatory bodies.

Implementing PLM in your business brings many advantages, however it needs to be implemented correctly to reap all of the benefits. The best way to do this is to partner with experts who understand PLM and utilize different and cutting-edge PLM tools available like Dassault’s ENOVIA solution.

Next Steps:

Latest White Papers

How to Measure Success in Software Development

How to Measure Success in Software Development

Software development comes with the occasional challenge, which is why working efficiently is vital. Here are some ways to ensure your organization is achieving success. What You Will Learn In this eBook, you will discover how engineering leaders can effectively...

Related Resources

The Role of Managed Services in Scaling Engineering Projects

The Role of Managed Services in Scaling Engineering Projects

Introductions Hi everybody. I'm Michael Roberts, Vice President of Sales and Marketing here at SPK and Associates. And today we're discussing a topic that's shaping the future of product development and engineering. And that's the role of managed services and managed...

A Compliance Checklist for an ISO 9001:2015 Audit

A Compliance Checklist for an ISO 9001:2015 Audit

ISO 9001:2015 is the internationally recognized standard for Quality Management Systems (QMS). It helps organizations consistently deliver quality products and services, meet customer expectations, and drive continual improvement. Achieving ISO 9001 certification...

Keeping Pace with Medical Device Software Updates

Keeping Pace with Medical Device Software Updates

As more and more software permeates products being released today, being able to update that software over time is an important part of the product lifecycle.  In the case of medical device software updates, these are essential for keeping devices safe.  From infusion...