Corrective and Preventive Action (CAPA) is a cornerstone of quality management in regulated industries. The CAPA process is essential not only for addressing current issues but also for proactively preventing future ones. It’s systematic, closed-loop, risk-based, and...
Automotive
A Step-by-Step Guide to ISO 26262 Compliance for Automotive Software Development
Agile Development in Regulated Environments – Part 1: Yes, it can work
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...
How Cloud-Based CAD Is Changing the Future of Collaborative Design
Traditional desktop-based CAD tools, while powerful, can have a hard time meeting the growing demands of modern engineering teams. They need better connectivity, scalability, and flexibility. That’s why cloud-based CAD (Computer-Aided Design) is quickly becoming the...
Navigating Tariffs: How SPK’s Expertise Can Lead to Enhanced Automation in U.S. Automotive Manufacturing
As new tariffs are enacted upon vehicles, auto parts, and raw materials, U.S. automotive manufacturers are facing new challenges. Escalating costs, disrupted supply chains, and uncertain trade policy are among these. While OEMs scramble to mitigate the impact, one...
Navigating Tariffs: How SPK’s Expertise Can Lead to Enhanced Automation in U.S. Medical Device Manufacturing
Tariffs have long been a tool of economic strategy, but recent escalations are impacting U.S. manufacturers, especially in the medical device industry. From 10% baseline tariffs to 245% duties on Chinese imports, companies now face inflated costs and disrupted global...
Accelerating Product Development the SPK Way
Developing high-quality products quickly can be a challenge without the proper tools, processes, and partners to help. Dive into this eBook to discover how partnering with SPK can help you achieve product development success.What You Will Learn In this eBook, we will...
Strategic Partners, Not Just Extra Hands
Today’s business environment requires companies to align with best-in-class vendors to be true, strategic partners. They need partners who understand their industry, their challenges, and their long-term goals. In the years we have partnered with our clients, some...
STRATTEC Security Corporation’s PTC Windchill PLM ROI Case Study
STRATTEC Security Corporation deployed PTC Windchill to replace its existing product lifecycle management (PLM) solution. Additionally, they wanted to improve product design tracking and collaboration. Nucleus found that PTC Windchill PLM enables increased...
Where Does ALM fit into the World of PLM?
Historically, Product Lifecycle Management (PLM) has its roots in mechanical and electrical engineering, specifically the automotive industry. Its use was pioneered to manage a product (for instance, a car) from inception and on through computer-aided design (CAD),...
PLM: Automate your Product Development Compliance Process
Developing new and innovative products is essential for companies to survive and thrive -- however safety can never take a backseat to innovation. That is why many companies, like those in the Medical Devices, Aeronautics and Automotive industries, have strict...
SOTIF ISO/ PAS 21448 Guide eBook
As autonomous technology outpaces regulatory standards, further focus is needed to ensure the safety of self-driving vehicles. SPK and Associates, in collaboration with PTC SOTIF ISO/PAS 21448, brings you an insightful guide - a comprehensive eBook on the Safety of...