Introductions Hi everybody. I'm Michael Roberts, Vice President of Sales and Marketing here at SPK and Associates. And today we're discussing a topic that's shaping the future of product development and engineering. And that's the role of managed services and managed...
ISO 9001:2015 is the internationally recognized standard for Quality Management Systems (QMS). It helps organizations consistently deliver quality products and services, meet customer expectations, and drive continual improvement. Achieving ISO 9001 certification...
Testing and calibration laboratories play a critical role in industries ranging from manufacturing and chemicals to healthcare and research. Their results often influence product safety, regulatory compliance, and customer trust. Organizations must ensure their...
Compliance with environment, health, and safety (EHS) regulations is critical for organizations across fields. This is not just due to the importance of creating safe products, but also due to the financial benefits. The inability to compete in markets with...
In regulated engineering environments, maintaining compliance and managing quality controls are non-negotiable. However, navigating compliance documentation, procedures, and quality workflows can feel overwhelming for engineers. That is where Botable comes in. Botable...
Delivering innovative products while ensuring quality and compliance can be tricky. Engineering teams in regulated industries must often navigate complexities such as Quality Management Systems (QMS) full of SOPs, work instructions, forms, and compliance...
In the aviation, space, and defense (AS&D) industries, a single component failure can lead to catastrophic consequences. To mitigate these risks and ensure consistent quality, the International Aerospace Quality Group (IAQG) developed the AS9100 Quality...
Quality assurance (QA) teams grapple with information overload, regulatory compliance, and bottlenecks caused by manual document retrieval. After years of working with different QA teams struggling with the same issues, we discovered Botable. Botable is an AI-driven...
Corrective and Preventive Action (CAPA) is a cornerstone of quality management in regulated industries. The CAPA process is essential not only for addressing current issues but also for proactively preventing future ones. It’s systematic, closed-loop, risk-based, and...
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....
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...
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...