The need for secure data storage and management is paramount in the modern business landscape. This is especially true when working within or migrating to a cloud-hosted environment. Partnering with a SOC 2-compliant cloud hosting vendor like SPK, means your sensitive...
Are you managing a growing team on Jira or Confluence Data Center but dreading the next user tier upgrade? If so, you are not alone. Many businesses who think they need a license upgrade know this can lead to additional costs that can strain budgets. What if there was...
Innovation is essential for staying ahead of competition in all industries, but especially in healthcare. Staying up to date with new technologies and compliance needs can improve outcomes for patients. The best way to ensure compliance is by utilizing the proper...
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...
