US FDA

FDA Metrics tracker

Updated FDA 483 citations analytics tool

As we all know there has been an increasing regulatory emphasis on the importance of Quality Metrics. Where there is a demand, there will also follow a supply and just in time, QikSolve have …

Surprised man

US FDA continue to find Data Integrity violations

Within the last 30 days, the US FDA released two new Warning Letters and yes-you guessed it, all contain data integrity violations. Lets look them below:
Falsifying test data from a stability batch
The latest Warning Letter is …

FDA inspection – 483 citation tracking

I’m excited to share that QikSolve has a new tool to track and trend all FDA inspection and 483 citations from 2008 to 2015, the tool dynamically scrapes data from various live websites and …

Comparison of Medical Device Standards

Whitepaper – ISO13485 & US FDA CFR 820 Comparison

Marketing medical devices at a global level can be a gruelling and onerous task when trying to achieve compliance to various differing regulations. FDA 21 CFR Part 820 compliance outlines Quality System Regulations for …