Standards

At first glance, the next version of RC14001, the management standard for the chemical industry, looks like a simplification. In practice, it gives organizations more flexibility, but also more responsibility. The revised standard no longer hands organizations a predefined list of stakeholder…

On April 2, 2026, the U.S. Food and Drug Administration issued a warning letter to Purolea Cosmetics Lab, reference 722591-04022026. By now, most of you have heard the story. The company had used AI agents to write drug product specifications, procedures, and master production records. No…

Consider an AI tool that delivers consistently accurate results and demonstrates impressive capabilities. If the people who are expected to rely on it can’t understand how decisions are reached or challenge outcomes that appear wrong, why would they trust it with an important decision? Would an…

Trust is the foundation of business and commerce. Every transaction, partnership, and working relationship depends, to some degree, on confidence that others will deliver on their commitments.

In business, we often focus on customer trust that products and services will meet their…

Manufacturing has a people problem, but not in the way we usually talk about it.

We talk about the skilled-labor shortage. We talk about retirements. We talk about doing more with fewer people. Usually those are treated as separate problems.

Quality management system software helps life sciences organizations manage documents, training, quality events, change controls, audits, and other regulated processes in one controlled environment.

Most electronic quality management systems (eQMS) offer some version of these core…