Regulatory Compliance – What Does It Mean for You?
Regulatory compliance is a topic that comes up often in my line of work. Here at Hawk Ridge Systems, we support a wide variety of customers in different industries, and regardless of the products that they provide to the market, they all have some things in common:
- They want to stay competitive.
- They want to design the best products possible for their customers.
- And they all have data to manage.
Now, for some organizations, data management might not be the center of interest right now, but I can tell you from experience, it will be at some point. Some organizations will keep it simple, while others might have more complex needs.
We often hear about the more complex needs from organizations that have to comply with some type of regulations from organizations that manage data regulations and standards. You’re probably familiar with some of those regulations that are set out by ISO, ITAR, the FDA, or others that pertain to your specific industry.
To achieve certification by one of these regulatory agencies like getting your company ISO 9001 Certified, Data Management will play a role in your overall Quality Management System (QMS) that’s required to get certified. To learn more about the specific steps you need to go through to achieve certification, talk to the folks around your company who are heading up those efforts. They may have expertise in these areas or are perhaps working with other consultants, accredited advisors, or industry experts to move along the right path.
How can a Data Management System help?
For many of the standards our customers need to adhere to, there’s a common theme amongst them: quality and security. Product Data Management (PDM) and Product Lifecycle Management (PLM) solutions are some of the first things that come to mind when we are tasked with managing those two concepts.
There’s a lot you’ll need to plan for in terms of an overarching Quality Management System, but managing your company’s data is the key aspect. For example, ISO 9001 certification involves continual audits to ensure that processes are being followed as defined by your QMS documentation.
For the products you produce, your CAD data is at the core of all deliverables to define how the product is manufactured. As part of a QMS, you’ll have a process defined to say how that design data will be managed, approved, and revised.
You’ll also need security measures in place to say who is allowed to access the data, which is important for things such as ITAR regulations. PDM or PLM software can be used as the vehicle to get you to these end goals.
PDM and PLM software are there to enforce that accountability. With PDM and PLM, you can facilitate electronic review and approval processes, implement electronic signature processes, and define how your files will be revised over time. And the best news of all is that you can audit all that information.
If you need to be able to prove when something changed, why something changed, and who changed it, that’s information that’s inherent within PDM and PLM software solutions. At any time, you can prove employees are following the processes defined by the company’s QMS, and this will go a long way toward helping achieve those quality or security standard certifications.
How Do You Get Started with Data Management?
At the end of the day, PDM or PLM is not a “Stamp of Approval” that will get you your company certified, but it plays an important role in the process. To do this right, you need well-defined processes in place. That’s why tools such as SOLIDWORKS PDM, SOLIDWORKS Manage PLM, and 3DEXPERIENCE, along with best-in-class support and guidance from Hawk Ridge Systems are among the best-fit tools for the job.
Watch as David Minerath and I discuss our experiences throughout the years and show examples of how we’ve helped customers pursue these goals. We’re not the ones who will get you certified, but when you have that bigger conversation at your company about the goals of your QMS, security needs, and how that relates to your data or process management, we are here to help.
Reach out to our team any time to discuss your goals and your needs. Our team of experts is here to support you along the way to becoming leaders in your industry.
