On December 17, 2015, the FDA issued a warning letter to Sun Pharmaceuticals Industries Ltd. in Gujarat, India. Sun Pharma’s website boasts that it is the “World’s 5th Largest Specialty Generic Pharmaceutical Company” with over 2,000 products in more than 150 markets across the globe. When an organization that large winds up with a […]
In our last CAPA-related blog post, we talked about the ability to attach supportive information to CAPA records (case data) in Argus Safety, Oracle’s drug safety and pharmacovigilance system. Today we’ll discuss another way the system can help comply with CAPA rules. CAPA Rule: System must allow the recording of issues and track their […]
On September 24, 2015, the FDA issued a Warning Letter to a manufacturer and distributor of medical devices for several violations. While the issues at hand may not seem severe, they do put the public at risk and reduce the confidence that the FDA has in the organization. Plus, they are inviting unwanted scrutiny […]
We recently discussed what CAPA means and why it’s important. Since many people in our field express confusion between the “CA” and the “PA,” I’ll quickly explain the difference between corrective action and preventive action. To put it simply, a corrective action can be defined as specific steps taken to address observed non-conformities or […]
In a handful of upcoming blog posts, we’ll be discussing a hot topic in our industry, along with a complementary piece of technology that might surprise you. The term Corrective and Preventive Actions, more commonly known as CAPAs, refers to an elaborate combination of processes and procedures used to maintain compliance with the following […]
On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: Is a web-based quality management system that includes document control and CAPA modules required to be 21 CFR Part 11 compliant?
U.S.-based Medical Device companies, take note: Between October 1 and December 23, 2014, the FDA issued 11 FDA Warning Letters to your peers. With an average of almost one per week, it’s clear that medical device companies are BIG on the FDA’s radar right now. While the Letters touch on nearly every aspect of the […]
“Quality, quality, quality.” You hear it all the time from your QA colleagues. There are so many forms to fill out, trainings to complete, procedures to read and follow, and internal audits to produce records for. Sometimes, it’s so overwhelming that we’re tempted to just tune it out. That is, until we read an FDA Warning […]