Posts Tagged ‘audit’

Identifying New Or Changed Data During A Clinical Data Review

In my previous post, we discussed some examples of business rules that might be applied depending on how many people are performing a clinical data review. Today, we’ll discuss approaches for selecting the data that is being reviewed. In any data review that occurs multiple times during the course of a study there are two […]

Got Maximo? How About An FDA-Compliant Maximo Cloud?

Let’s tackle a tough one… It’s one thing to put IBM Maximo, an enterprise asset management solution, in the cloud. It’s something completely different to put IBM Maximo in an FDA-compliant cloud!  At Perficient, we don’t do the usual – we cater to the difficult and never been done before, crowd. Our cloud has been serving […]

How Much System Access Should We Give An FDA Inspector?

  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: The Scope section requires access to electronic records and signatures (ER/ES) at all times. What if the electronic system used by a […]

Easier FDA Audits With Google Search Appliance

  The U.S. government recently disclosed the amount of time it takes to comply with the FDA’s requirements for the reporting and recordkeeping of human drugs and biologics, related to Investigational New Drug (IND) applications. It probably won’t come as a surprise that it takes an exhausting 22,801,297 total hours. Yes, you read that correctly. 

The Trifecta Of Validation

Validation. Admit it – you cringed a little. It’s almost like a dirty word in our industry. That thing that slows down system implementations. That thing that adds a bunch of time and cost to IT projects. That annoying, but necessary, evil. Well, okay, it’s not really “evil,” per say. It is, after all, designed […]

This Recent FDA Warning Letter Shows You Exactly Why Quality Matters

“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 […]