Resources to Help Accelerate Your Product Development
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Why Engineering Teams Struggle With Compliance – And How SPK ACEs Solves It
From my decades of experience in the IT and Engineering space, I’ve seen firsthand how even the most capable engineering teams can falter under the weight of compliance requirements. In highly regulated industries, the need to innovate quickly often clashes with the...
Meet the Experts: Jake Ferretti
Jake Ferretti is a professional services engineer who joined SPK in June of 2024. Before joining SPK, Jake worked for a zero-trust security startup company. In his current role, he ensures customer satisfaction by providing AWS, Azure, GCP, and other technical...
A Compliance Guide to Ensuring Software Validation in FDA-Regulated Medical Devices
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...
Why Every Engineering Team Needs a Strong PDM Strategy
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....
How to Achieve Compliance with FDA 21 CFR Part 11 for Electronic Records and Signatures
In highly regulated industries like medical devices, maintaining data integrity and regulatory compliance is non-negotiable. One of the key regulations in this space is FDA 21 CFR Part 11, which governs the use of electronic records and electronic signatures. It...
Jira Admin vs. Consultant vs. Architect: Who Does What and When Do You Need Each?
At SPK and Associates, we regularly help companies get clarity around their Atlassian investment. One common area of confusion is understanding the difference between a Jira Administrator, a Jira Consultant (or Expert), and a Jira Architect. These roles aren’t...
Uniting Teams Across Your Organization with the Atlassian System of Work
Aligning cross-functional teams is more critical than ever for modern organizations. Miscommunication, siloed information, and disconnected tools often stand in the way of productivity and progress. Atlassian, a leader in team collaboration, has developed a...
How to Unlock the True Value of Copilot
You will be taken to another page to registerBy submitting this form, I acknowledge receipt of SPK and Associates' Privacy Policy.You’ve launched Copilot! Maybe even multiple agents. But if you’re wondering why the results feel… underwhelming, you’re not alone. Even...
Lessons Learned in Overcoming Digital Thread Challenges
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...
Strategies to Overcome the Top Challenges in Medical Device Manufacturing
Medical device manufacturing is one of the most regulated, complex, and high-stakes industries in the world. From ensuring compliance with evolving global regulations to protecting patient data, companies face a multitude of hurdles. These are just what is expected....
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With being in business for over 20 years, our experts have experience with all types of business situations, technology challenges and implementation/support obstacles. Contact us if you’re looking to solve a specific challenge.
