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Recent Posts
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...
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....
Level Up Your Creo Skills with These 10 Tips
Creo is a powerful CAD tool that offers an immense range of capabilities. No matter how long you've been using it, there's always room to level up. Whether you’re designing complex assemblies or optimizing for manufacturability, these best practices will help you...