Sterling Medical Devices & RBC Medical Innovations have combined to form Vantage MedTech! Learn More

Product Traceability: The Key to Effective Design Control

Author: Anish Prabhu | February 27, 2023

Man creating product traceability strategy plan.

Your goal: To efficiently develop your product allowing for maximum success throughout the product lifecycle —whether it’s a cutting-edge medical device, an embedded system, an advanced aerospace design, or a new-generation automotive innovation.

Whatever your industry, this is no easy task. Product development always requires end-to-end visualization.

Product traceability is the process that makes this constant awareness possible.

Complexity demands comprehensive, continuous traceability in product  development.

Why is traceability important? Product developers and managers are all dealing with ever-growing product complexity. In multifaceted environments, a product’s every element needs to be continuously monitored and tracked to ensure effective development and evolution. Companies using paper-based design processes risk falling behind their competitors, yet even those employing digital product traceability must ensure they meet high standards for comprehensiveness and full transparency.

State-of-the-art product traceability holistically verifies and helps manage the product development process, providing a 360° perspective on product development and implementation. To deliver optimum value, product traceability software has to clarify with forensic-level probability—exactly how the product progresses from its origins and initial development steps to its eventual use; and also, beyond that, through its continuing evolution.

Product traceability overcomes obstacles.

Because advanced product traceability software links each step, process, and system based on pre-set rules and business logic, it can decipher even the most complex implementation. Evidence trails ensure that each action produces consistent and reproducible results. Every change is tracked and time-stamped. Subsystems work together, monitoring every process and identifying related impacts.

Consider, for example, embedded systems. They can pose particular design and development challenges because an overlooked system requirement could lead to painful redesign late in the process. Traceability matrix reflecting in-depth requirements traceability is critical for these systems because it is designed to ensure all the product’s requirements have been thoroughly addressed during each phase of the project. Yet even some automated product traceability tools for requirements traceability require manual backtracking, which can be more time-consuming than creating the requirement in the first place. When executed effectively, the possibility of scope holes in the developed system is virtually eliminated. Using a traceability matrix, requirements are internally consistent with each other across the board, and everything from the user story, business requirements, system requirements, test cases, design, risks and code changes, to bug reporting and fixing—all the way back to the user story—are completely and accurately managed.

Product traceability solutions for maximum impact.

Some companies continue to rely on lifecycle management tools that do not fully automate the entire traceability process, requiring users to manually update many aspects of the data. Others use paper based approach which is a manual and tedious process and often prone to human error.

On the other hand, product traceability, offered by Polarion ALM®,  cultivates successful product development. It provides a level of efficiency that partially automated and manual matrices cannot. The industry-leading traceability software offering change management, real-time collaboration, regulatory compliance, and so much more, Polarion provides tracking capabilities that identify specific, disparate work items, define their various interrelationships, and deliver a complete view of the process hierarchy, forward and backward, at every time point.

These advanced capabilities, including live dashboard and detailed reports, ensure compliance with industry standards without relying on error-prone manual file updates. And Polarion delivers the most accurate visibility into supplier activity currently available, enabling a more streamlined decision making process.

Let us add our product management and traceability expertise to your process.

A truly powerful traceability process  can mean the difference between being on time and on budget—or being beset by inefficiencies, bottlenecks, and distractions. That’s why so many companies turn to Sterling to implement Polarion capabilities, not only for traceability in their development and manufacturing process, but also for the full Polarion product development ecosystem—including quality management, change management, requirements management, scalability, risk management, compliance, design, implementation, testing, and continuing support.

Sterling’s leadership in lifecycle management through Polarion ALM software means we will help you determine which specific processes are best for your needs; then we will implement the right solution every time.

Sterling provides expert Polarion consultants to help you document, track and monitor every aspect of your project, getting your product to market faster and more effectively, while propelling you directly toward your business goals. If you are seeking the highest levels of efficiency for product development, maintenance, and evolution through product traceability —whether your company is in a regulated industry or not—Sterling will make a measurable difference.

To maximize the benefits of Polarion, contact Sterling for more information. To learn more about proven processes to help you work efficiently, effectively, and take your business to the next level, download our masterclass on 6 Reasons to Maintain Traceability.

Share

Contact Us

  • This field is for validation purposes and should be left unchanged.

Resources

March 29, 2021

What Is Polarion?

Learn more about our tool that streamlines product development in a compliance-based...
Watch Now >
View More Videos
Professional on computer reviewing ISO documents.

October 18, 2023

What’s New in ISO 10993-17:2023?

In early September, the International Organization for Standardization (ISO) released new ISO standards for medical devices: the ISO 10993-17:2023 (en) Biological Evaluation of Medical...
Read More >
View More Articles

April 19, 2023

Requirements Management and Cybersecurity Webinar

Do you struggle with managing requirements for your products? Are you concerned about cybersecurity and the potential impact of software...
Read More >
View More Download Tools

Sign up for regular updates and resources

This field is for validation purposes and should be left unchanged.

Dan Sterling Photo of Dan Sterling President
250 Moonachie Rd., Suite 400 Moonachie, NJ 07074
201-227-7569 dan@sterlingmedicaldevices.com
John Campbell Photo of John Campbell VP of Operations
250 Moonachie Rd., Suite 400 Moonachie, NJ 07074
201-227-7569 jc@sterlingplm.com
John Fargo Photo of DanJohn Fargo PLM Manager
250 Moonachie Rd., Suite 400 Moonachie, NJ 07074
201-227-7569 jf@sterlingplm.com