FDA Compliance
For decades, the process industries have relied on layers of protection to prevent hazardous events. When risk reduction requirements were high, safety instrumented systems (SIS), governed by standards such as IEC/ISA 61511, provided a clear framework for design, operation, and life-cycle…
Validating AI software makes most quality teams uneasy.
Their unease is not unjustified. The new Annex 22 provides a framework for AI use, but the guidance remains in draft. Most quality teams still have questions, especially around validation.
Why? Quality teams are…
Octave, a new company from Hexagon, is one of the latest additions in a string of improvements and innovations. This company will unite several Hexagon departments and functions, increase the efficiency of Hexagon’s digital communication, and provide support for vital infrastructure. Vick…
Quality leaders know that an audit rarely fails because a company lacks documentation. It fails because the information exists somewhere but can’t be retrieved, verified, or executed consistently when it matters. For decades, preparing for an audit meant assembling binders, tracking down…
Regulated manufacturers today face a paradox. As products become more complex and regulatory oversight more stringent, the volume of quality data required to demonstrate compliance has increased dramatically. At the same time, many organizations continue to rely on fragmented systems—documents…
The U.S. Department of Energy (DOE) Oak Ridge National Laboratory (ORNL) and Kairos Power have entered into a $27 million strategic partnership to accelerate the technology needed to deploy a new generation of advanced nuclear reactors and support U.S. nuclear energy goals.
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