You know which rules you’re responsible for following, but is that enough? Agencies like the FDA rarely make exceptions for firms that misinterpret the law, and although you may be able [...] Read More
By default, your desire to market products in Europe makes EU cybersecurity compliance one of your primary organizational goals. Unfortunately, the path to effective regulatory adherence [...] Read More
CAPAs, or Corrective and Preventive Actions, are largely designed to help GxP-regulated firms handle non-conformity problems. In order to deal with undesirable occurrences in manufacturing processes, [...] Read More
The methodologies your firm employs in the creation of pharmaceuticals, medicines and similar products designed for human consumption are most likely unique. Even if you follow relatively [...] Read More
Although currently seldom used, cloud services are increasingly popular for life sciences firms that want to keep up with their competition. These firms use distributed computing architectures to [...] Read More
Quality assurance (QA) isn’t something implemented solely for consumer satisfaction. In most industries, including that of medical device manufacturing, your QA efforts have very real effects on your ability to legally conduct business in the United States, EU and other global locations.
In some cases, meeting quality management regulations may be more difficult using only in-house resources. Learn how [...] Read More