The right electronic Quality Management System (eQMS) can help strengthen your compliance processes and build a culture of quality within your organization. Discover the eight best quality management software and learn how to choose the right one for...
The modern medical life science industry is a multiple-wheeled machine. It takes a lot of groups working in tandem to get a medical product on the market. While the majority of the production and assembling might happen in the manufacturing facilitie...
As the life sciences industry becomes increasingly regulated and competitive, quality management has become more vital than ever. Are you confident in your organization’s Quality Management Maturity (QMM)?
Introduction Despite its crucial role in life sciences, college curricula often overlook technical writing. However, life sciences professionals are expected to possess this skill and demonstrate it at a level that frequently exceeds their capabiliti...
How to get your management team to say “Yes” to an eQMS As a quality professional, you know the value of an eQMS. You’re aware of the drawbacks of manual or paper-based systems and how an eQMS can enhance speed, safety, and efficiency in your organiz...
A narrow focus on regulatory compliance can hinder organizations from fully embracing and benefiting from quality and operational excellence.
Standard operating procedures (SOPs) describe, well, the standard operating procedures of a company. They provide step-by-step instructions on how to perform the most common tasks at a company. When SOPs are efficient, they decrease miscommunication ...
The FDA is transitioning from Computer System Validation (CSV) to Computer Software Assurance (CSA) for computers and automated data processing systems used as part of medical device production or medical device quality systems. So, what is the diffe...
Achieving excellence and efficiency requires mastering the right tools in Quality Assurance (QA). Today, there are more than a hundred different QA tools available, making the selection process challenging.
In May 2017, Life Science organizations were hit by one of the biggest cybersecurity incidents - the WannaCry ransomware attack. WannaCry spread rapidly across networks, encrypting files and demanding ransom payments in Bitcoin to decrypt them. The U...
Even an organization with stellar leadership and a solid core of employees experiences hiccups from time to time. Despite having assembled all the ingredients for a great organizational culture or a superior product, a company or department is not li...
Healthcare faces complex challenges in a world that is becoming more digital day-to-day. It has become clear that healthcare companies will need to embrace open systems that allow for the sophisticated analysis of multiple data streams and the develo...
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