Unlock the secrets to seamless FDA compliance with our comprehensive eBook. This practical guide breaks down the regulations and standards that matter most, including 21 CFR Part 11 and Part 820, and walks you step-by-step through risk-based validation, robust...
You will be taken to another page to registerBy submitting this form, I acknowledge receipt of SPK and Associates' Privacy Policy.Engineering change is inevitable—but unmanaged change can lead to delays, compliance issues, and costly mistakes. Implementing a...
The value system and practices that embody Agile Software Development have been around for well over a decade, and have been touted as having "crossed the chasm" by organizations such as the Agile Alliance, Gartner, and Forrester Research. Numerous studies indicate...
Welcome to Why Every Engineering Team Needs a Strong PDM Strategy Hey everyone and welcome back to our vlog series where we talk about all things engineering, IT, and innovation. I'm Michael Roberts, Vice President of Sales and Marketing here at SPK and Associates....
The digital thread is a transformative approach to connecting data, systems, and teams across the product lifecycle. It enables seamless access to real-time data and traceability across departments and tools. However, for many organizations, implementing a robust...
Put it in the cloud. You’ve heard this catch phrase over and over again, more so in recent years with the proliferation of online technologies and services. As more and more PLM software vendors choose to move their application to the cloud, should you consider moving...
When you’re a discrete manufacturer, your product designs and data are the crown jewels of your business. They define your intellectual property, drive your revenue, and differentiate you from the competition. Entrusting that IP to a CAD or PLM software vendor is a...
Product designs, documentation, and processes aren’t just valuable intellectual property, they’re your license to operate. In the highly regulated medical device industry, manufacturers must carefully consider these factors. If you’re using a Product Lifecycle...
Achieving compliance with ISO 9001 requires making quality and version control a priority. This eBook explores our experts’ ten best practices for ensuring ISO 9001 compliance.What You Will Learn Discover tips for achieving ISO 9001 certification such as: Establish a...
Meeting the highest levels of product quality requires leading engineering and manufacturing teams to utilize integrated solutions. Bringing together advanced CAD and Product Lifecycle Management (PLM) capabilities can lead to lower costs and increased innovation....
As companies grow and product complexity increases, selecting the right Product Lifecycle Management (PLM) system becomes a critical decision. Two of the most widely used PLM platforms—Arena and Windchill—offer distinct approaches to managing product data, enabling...
Regulated industries face immense complexity in designing, producing, and maintaining high-quality products. Balancing this while ensuring compliance, managing data, and accelerating innovation is not possible without the proper tools. That’s why Product Lifecycle...