Introduction: In this article, we will examine two key aspects of quality management: quality assurance and quality control. These are two broad approaches that businesses […]
What is 21 CFR Part 11? 21 CFR Part 11 establishes US FDA regulations on Electronic Records & Electronic Signature (ERES) which includes electronic submissions […]
For highly regulated medical device companies and life science industries, it has become a challenge to achieve 21 CFR Part 11 compliance and a matter […]
When you are working for a drug manufacturing unit, clinical trials facilities, or a medical device company, you can expect random and routine inspections by […]
Laboratories in the field of life sciences play an essential role in research, testing, and product development for medical devices and drugs of all kinds. […]
A large portion of the success of the pharmaceutical industry revolves around successful sales. Without good sales reps, the industry could easily falter. But selling […]
With technology rapidly evolving, we have seen the digitization of many processes that were once done manually. The field of life sciences is no exception. […]
The regulations from the US Food and Drug Administration (FDA) that apply to how various life sciences companies handle electronic files and electronic signatures is […]
Whether a biopharmaceutical company is large or small, research is essential to moving industry knowledge forward and achieving the company’s mission. Does biopharmaceutical research fall […]
In the digital age of the twenty-first century, it’s only natural for all kinds of companies to handle more and more of their business operations […]
The healthy lub-dub sound of your heart valves is one that many people take for granted until they experience or are diagnosed with a heart […]
Ever watch the newest Sci-Fi episodes (or the older ones) and wonder why your own medical treatment couldn’t be that easy? Here are a few […]