SCOTTS VALLEY, CA - Engineering and IT leader SPK and Associates is pleased to announce its achievement of SOC 2 Type 1 certification. The SOC 2 Type 1 certification attests that SPK’s information security meets or exceeds the rigorous standards set forth by AICPA....
Selecting the best Marketplace apps and integrations for your unique business needs is crucial to enhancing your Atlassian Cloud environment. With hundreds of apps available, it can be difficult to know which options will work best for you. Here are our suggestions...
Are you interested in improving your business’s workflows to remain competitive among other production companies? Proper intellectual property management is vital for achieving ultimate efficiency. Businesses that successfully secure, reuse, and share their...
This article reviews what an FDA 483 Observation looks like, some of the more common issues flagged in medical device companies, and how to respond.
Ensuring avionics software is reliable and safe is a top priority for aviation engineers. However, maintaining compliance throughout the software lifecycle is no simple task. Utilizing an ALM tool such as PTC’s Codebeamer can help ensure compliance with aviation...
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...
Design Output: A Review of 21 C.F.R. §820.30(d) and FDA Warning Letter Trends
SPK and Associates routinely review warning letters to help our clients stay in step with FDA trends. One of the problem areas most often cited in company audits continue to be the CAPA system/program. This month we will take a look at some of the latest FDA...
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...
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...
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....
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...
