This post provides a framework for configuring the ServiceNow Platform Tables to meet today's data integrity standards in order to comply with 21 CFR Part 11 and other predicate GxP regulations. I will attempt to cover:
How to leverage in-built ServiceNow features to ensure Tables are configured for GxP Compliance?
How to design the configuration qualification (CQ) tests?
How to ensure "validated status" (VS) on a ongoing basis?
I very frequently get asked whether Azure Platform-as-a Service (PaaS which includes Serverless Architectures) can be qualified as well? Surprisingly, this question is asked even by Azure users who agree that Azure IaaS can be qualified. In this blog post I will provide a prescriptive guide to intelligently qualify Azure PaaS and maintain it in a qualified state (QS).
Read MoreThe million dollar question is "Can Microsoft Azure be qualified?". In this blog post I will provide a prescriptive guide on not just "how to qualify", but also how to maintain the qualified state intelligently.
Read MoreThe million dollar question is "Can AWS be qualified?". In this blog post I will provide a prescriptive guide on not just "how to qualify", but also how to maintain the qualified state intelligently.
Read MoreFDA put out its DRAFT guidance on Data Integrity and Compliance with cGMP in April 2016.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.
Read MoreAny 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....
Read MoreThe question is "Can Amazon AWS or Microsoft Azure be qualified so that 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 It is not possible to qualify an infrastructure where changes are released without release notes with such an outdated mindset and toolset.
Read Morehis blog post is Part 3 in this series. What are the key process steps involved in continuously validating a Cloud App?
Read MoreThis 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.
Read MoreWhat 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.
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