FDA’s CDRH is planning on releasing a guidance on Computer Software Assurance (CSA) for Manufacturing, Operations, and Quality System Software in 2020 (applicable to non-product CSV only). Currently, it is on their “A” list. There has been a lot of industry chatter about this particular guidance related to computer validation. Everyone is eager to know about FDA’s current position on computer validation. So much has changed in the last two decades and we still don’t know what FDA’s current thinking is when it comes to the “cloud”. FDA has surely managed to keep us behind a “dark cloud”!

PostNagesh NamaOctober 31, 2019FDA's CSA, FDA GuidanceComment

xLM for TestOps - Continuous Qualification for AWS/Azure

Many life-science companies are asking the question “Can I move my GxP workloads into the public cloud?” Answering “yes” to this question leads to another question: “What toolset do I need to qualify the various IaaS/PaaS services that are constantly changing?”.

Publication, PostNagesh NamaJuly 6, 2019TestOPs, DevOps, Test Automation, azure qualification, AWS QualificationComment

Is Sample Based Data Migration Testing GxP Compliant?

Publication, PostNagesh NamaApril 21, 2019data integrity, data migrationComment

How does Continuous Validation Stack Up against FDA's new CSA?

Publication, PostNagesh NamaApril 13, 2019FDA's CSA, FDA GuidanceComment

What's the Scoop on FDA's Upcoming CSA (Computer Software Assurance) Guidance?

Publication, PostNagesh NamaApril 13, 2019FDA Guidance, FDA's CSAComment

xLM for DevOps - Introducing vCD (Validated Continuous Delivery)

The main objective of this post to answer the following questions. I know a picture is worth a thousand words and so I will do this with illustrations.

Can "Validation" and "DevOps" be used in the same sentence (like vCD - Validated Continuous Delivery)?
Is DevOps a viable model for validated apps in GxP Environments?
How can one ensure the "validation fidelity" in a DevOps environment?

Publication, PostNagesh NamaAugust 29, 2018xLM, continuous validation, Test Automation, DevOps, vCD, validated continuous deliveryComment

xLM App for ServiceNow is available in the NOW Store...

PHILADELPHIA, PA - 07/02/2018 — xLM, LLC, the first managed service provider for delivering continuously validated cloud apps, today announced that xLM App is available in the ServiceNow App Store.

Press ReleaseNagesh NamaJuly 3, 2018partnershipComment

Continuous Validation for ServiceNow - HOW IS IT DONE?

What are the key steps involved in continuously validating a ServiceNow 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, it does not make any value-sense to pin to an "ancient" version. Thus this Continuous Validation Framework is designed to mitigate these risks and ensure that your ServiceNow app is maintained in a validated state.

Publication, PostNagesh NamaJuly 2, 2018servicenow, continuous validation, Cloud Qualification, xLMComment

ServiceNow: Data Integrity Guide for GxP Compliance - Tables

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?

Post, PublicationNagesh NamaJuly 2, 2018servicenow, continuous validation, data integrity, audit trail, xLMComment

A Step-by-Step Guide to "continuously" Qualify Microsoft Azure PaaS and Serverless Architectures

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).