In June 2020, the U.S. Food and Drug Administration (FDA) issued a warning letter to a drug manufacturing facility, citing a number of infractions, including these common data integrity issues: 1 Missing raw data files associated with recovered solvent testing were observed in folders on the local hard drive of…

In medical device development, speed, efficiency, and accuracy with document control processes are a top priority. Global regulatory agencies recognize this and continue to evolve their processes and technologies to help companies achieve compliance with this aspect of quality management. …

Drug accountability in clinical trials is pretty much what you’d expect. It holds the organizations and people involved in the trial accountable for how they handled the drug being used. Improper drug accountability places the entire clinical trial at risk. Pharmaceutical companies, and regulators, can’t be assured the results of…

U.S. Food and Drug Administration (FDA) inspections or customer audits are some of the most stressful experiences from working in the life sciences industry. I worked for medical device manufacturers before joining MasterControl in 2006 and I’ve been through more than my fair share of audits and inspections. The FDA…

Editor’s note: When Lillian Erickson worked as global quality manager for MasterControl, she authored this creative post to help other parents who are quality professionals survive and have fun at Career Day. When it was time to celebrate Career Day at my daughter’s school, she begged me to come talk…

Because financial success hinges on digitization, paper-based processes need to be eliminated. As reported by Deloitte, digitally mature companies are, “about twice as likely as lower-maturity ones to report net profit margins and annual growth significantly above their industry average.” …

Only a year ago, research examined the impact of COVID-19 on trends in biopharmaceutical industry and bioprocessing and found that “use of contract manufacturing organizations (CMOs) and other outsourcing will continue to accelerate.” (1) More than 12 months later, this prediction is proving to be accurate. CMOs and contract development…

If you’re a quality manager, you have a demanding job. In a nutshell, you’re responsible for ensuring satisfactory and consistent quality throughout the entire product development life cycle — a responsibility which requires you to wield a massive skill set and wear many different hats. Your daily existence revolves around…

There are many measures proactive people take to prepare for potential disasters. Buying homeowner’s insurance, packing emergency “bug-out” bags, and storing viable supplies of shelf-stable foods are just a few common examples of preparedness contingencies. As recent events have shown, a lack of preparedness during a state of panic can…