Learning More About AssurX

A couple years ago, I learned about AssurX and their electronic systems for quality procedures, CAPAs, e-records, etc. I was with a small company and assumed their solutions were out of our price range.

Fast forward a few years. I rediscovered AssurX on twitter. I’ve been corresponding back and forth, following the AssurX blog, and so on. I’m learning that the assumption I formed a few years ago may not be true. While AssurX does work with some of the “big boys & girls” in the medical device industry, they have also worked with a few smaller businesses as well. I hope to be able to pass along some of these examples and case studies. If you would like to learn more about AssurX’s products and services, I’m happy to make an introduction.

In the meantime, I’d like to share a couple of blog posts from AssurX about some client engagements they’ve had:

Keystone Dental

Instead of using a manual, paper-based system that tediously captures data, the new electronic system has streamlined the process; it’s focused on capturing the essential and actionable information quickly.  The implementation activity allowed Keystone to critically re-evaluate their current manual complaint handling system and design a robust solution by leveraging [the AssurX] CATSWeb’s flexible capability.

“CATSWeb can mirror the process in a way that we get to choose, and not the other way around,” added Jancsy. Keystone will integrate the CATSWeb quality system with Salesforce.com and their IFS ERP.  The first process rolling out is complaint handling and then CAPA, audits, training and change control during 2009.

Be sure to read the entire post about Keystone Dental . . .

Oliver-Tolas

She knew they had to move everything – forms, testing, and all quality systems – from paper to electronic. “Our old way was time consuming and cumbersome…we were faxing hard copies back and forth and it took forever,” Lora recalls.

There were four key requirements for a new electronic system:

• Reasonable price
• 21 CFR Part 11 compliance
• It had to meet their needs for document control
• Fast implementation

“We didn’t have 12 – 18 months implementation time. I didn’t want that kind of delay”

Be sure to read the entire post about Oliver-Tolas . . .