Audits are an important business process, but doing them manually and without an audit schedule is inefficient and risky. This article discusses the power of automation in quality audits, how automating improves efficiency, and how it influences compliance.
As one does about this time of year, ETQ has once again taken out its crystal ball to peer into the upcoming new year to identify the trends, behaviors and events that will shape how manufacturers perceive and interact with technology as a means to support their overall enterprise-wide quality goals.
Two things are true when it comes to making important decisions that impact your company. One, you need a way to quantify risk to make the best choice, and two, you need to be able to explain that choice.
There continue to be many questions around Hazard Analysis and Risk-based Preventive Controls (HARPC) and how a company’s food safety program will need to change to meet the new Food Safety Modernization Act (FSMA) requirements. Through FSMA, the FDA has basically stated that Prerequisite Program (PRPs) are now considered of equal importance as Critical Control Points (CCPs), clumping them all together and calling them preventive controls.
For the final week of World Quality Month, we’re featuring global medical device leader Owen Mumford, an ETQ Quality Champion that designs, develops and commercializes medical products under its own brand and for the world’s major pharmaceutical and diagnostic companies. The company has long been recognized for its high quality standards and dedication to continuous improvement.
Generative AI is a form of artificial intelligence that “self-learns” via large amounts of publicly available data. The speed at which it processes data and responds to natural language prompts to create highly relevant content is unprecedented.
It’s no surprise to learn that demand for cloud computing applications for the enterprise is soaring. What’s not as well known how to decide which application development approach is best for your organization.
With regulatory requirements changing regularly, staying up to date and maintaining audit readiness is critical. Effective quality management protects an organization's reputation and guarantees ongoing compliance.
Inefficient quality processes can seriously impact the ability to successfully commercialize critical drugs and medical devices. This is a topic we recently wrote about in Pharma Manufacturing. Quality across the full drug development lifecycle can reduce the risk of non-compliance and save companies millions of dollars in fines, lost time and expended resources.
As industries evolve, ensuring product excellence and safety becomes ever more critical. The digital-first era has not only influenced our daily lives but has also played a pivotal role in shaping and enhancing the quality culture in modern enterprises.
