FDA put out its DRAFT guidance on Data Integrity and Compliance with cGMP in April 2016. This guidance is important because we come to understand FDA's thinking on Data Integrity.

Any Track and Trace Enterprise application is a complex implementation which has many interfaces.  What are the requirements of a validation toolset for such an application?  Let us take a look..

The question is "Can Amazon AWS or Microsoft Azure be qualified so that I Life Science companies can run validated apps on it?"   

Cloud releases updates and changes at such great velocities that leaves all validation specialists continuously wondering on how to qualify it.  Traditional strategies including GAMP 5 was never designed to address continuous changes.  These models were designed for a "waterfall" world and not an "agile" one.  It is not possible to qualify an infrastructure where changes are released without release notes with such an outdated mindset and toolset.

This blog post is Part 3 in this series. What are the key process steps involved in continuously validating a Cloud App?

This blog post is Part 2 in this series. What are the key steps involved in continuously validating a Cloud App? (click here for Part 1). 

The above diagram depicts the key elements of a Continuous Validation Program for a Cloud App. One has to bear in mind that the underlying IaaS and PaaS infrastructure is constantly changing. In fact, the Cloud App itself is continuously changing. In the new cloud world very rarely you are given the option of pinning to an "ancient" version. Thus this Continuous Validation Framework is designed to mitigate these risks and ensure that your cloud app is maintained in a validated state.

What do you need to implement a true continuous validation platform for a Cloud App?  This series of blog posts will answer this question.  This blog post is Part 1 in the series and covers the infrastructure required to implement this platform.

Not a day goes by without a client posing this question:  Can Amazon AWS or Microsoft Azure be qualified so that I can run my apps on it?  Here is a 9 Step systematic answer to this very popular question....

Life science companies are adopting the Cloud (Public, Private, Hybrid) but are constantly faced with the "Validation Challenge": How can I validate the Cloud Stack (IaaS, PaaS, SaaS) to meet the various GxPs?