The ability of executives to harness insights from data is crucial for driving strategic decision-making and maintaining competitive advantage. In our data advisory engagements, we are often helping teams and executives better understand their data. Through those...
Compliance & Regulatory
A Detailed Comparison of PTC Windchill and Siemens Teamcenter
Two of the most common enterprise PLM software on the market are PTC Windchill and Siemens Teamcenter These product lifecycle management solutions have many similarities, but there are a few key differences that may be deciding factors in choosing one. At SPK, we...
The Role of PLM in Orchestrating the Product Digital Thread
Product Lifecycle Management (PLM) plays an important role in the manufacturing industry. Ensuring all factors of a product are well-documented is a priority for every business. Keeping this information organized is not just a good business practice, but it...
Driving Quality with ISO 9001 Compliance in the Automotive Industry
The automotive industry is one of the largest industries in the world. The market is projected to grow to 2.95 trillion U.S. dollars this past year, causing a substantial amount of disruption. With this immense scale, comes many requirements manufacturers must follow....
Optimizing Document Control Processes: A Deep Dive into ISO 9001:2015 and Good Industry Practices
ISO standard 9001:2015 refers to the regulatory requirements companies must abide by when managing the quality of their product(s). The main goals of ISO 9001 are customer satisfaction and product improvement. There are a few main things that must be defined when...
ISO 9001: Quality Management in Medical Device Manufacturing
Ensuring medical device quality is critical. So, you’ll need to understand and meet ISO requirements to appeal to potential buyers and streamline management. In this blog, we discuss ISO 9001 as it relates to medical device manufacturing, what your business can do to...
A Guide to Regulatory Compliance in Atlassian Cloud (EBA, BaFin, HIPAA, and more)
It's good practice to observe the regulations a software solution conforms to before choosing one for your business. In this blog post, we will be exploring the updates Atlassian Cloud has added to its regulatory compliance guidelines in recent years.Atlassian Cloud...
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...
Shifting from FDA 21 CFR Part 820 to ISO 13485
In this Vlog, Chris McHale, Co-founder, and CEO of SPK and Associates is joined by Carlos Almeida, Vice President of Engineering. Together, they’re discussing FDA compliance and the recent shifts impacting medical device companies. Topics for discussion include...
Excellence in Automotive Software Engineering eBook
ALM tooling, when implemented correctly, can support automotive software engineering, Agile transformation journeys and linking requirements to business strategy, encouraging collaboration. Additionally, it can be helpful for providing an overview of QA and testing...
DevOps as a Service Supercharges Development Pipelines
It seems like just about every company is now a part-time or full-time software company. But, for small and mid sized companies, employing effective practices, such as DevOps to manage the day-to-day, might not be feasible. However, there is a solution. It’s called...
SBOM Compliance: Navigating the Regulatory Landscape
Recent events, such as the Log4Shell / Log4J vulnerability, underscore the importance of best practices for cybersecurity in software development. And, with increasing cyber attacks, it’s more important than ever that organizations can pre-empt and respond to emerging...