Nagesh Nama
Is Sample Based Data Migration Testing GxP ...
Is Sample Based Data Migration Testing GxP Compliant?
Video
Nagesh Nama
What's the Scoop on FDA's Upcoming CSA ...
What's the Scoop on FDA's Upcoming CSA (Computer Software Assurance) Guidance?
Nagesh Nama
xLM for DevOps - Introducing vCD (Validated ...

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.

  1. Can "Validation" and "DevOps" be used in the same sentence (like vCD - Validated Continuous Delivery)?

  2. Is DevOps a viable model for validated apps in GxP Environments?

  3. How can one ensure the "validation fidelity" in a DevOps environment?

xLM for DevOps - Introducing vCD (Validated Continuous Delivery)
Nagesh Nama
Continuous Validation for ServiceNow - HOW IS ...

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.

Continuous Validation for ServiceNow - HOW IS IT DONE?
Nagesh Nama
A Step-by-Step Guide to "continuously" Qualify ...

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). 

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

Is Sample Based Data Migration Testing GxP Compliant?

xLM for DevOps - Introducing vCD (Validated Continuous Delivery)

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.

  1. Can "Validation" and "DevOps" be used in the same sentence (like vCD - Validated Continuous Delivery)?

  2. Is DevOps a viable model for validated apps in GxP Environments?

  3. How can one ensure the "validation fidelity" in a DevOps environment?

ServiceNow: Data Integrity Guide for GxP Compliance - Tables

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:

  1. How to leverage in-built ServiceNow features to ensure Tables are configured for GxP Compliance?

  2. How to design the configuration qualification (CQ) tests?

  3. How to ensure "validated status" (VS) on a ongoing basis?

Continuous Validation for ServiceNow - HOW IS IT DONE?

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.

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

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). 

Inflectra, xLM Partner to Deliver continuously validated Spira Team Apps

Inflectra, xLM Partner to Deliver continuously validated Spira Team Apps

PHILADELPHIA, PA - 05/18/2017 /EASY NEWSWIRE/ — xLM, LLC, the first managed service provider for delivering continuously validated cloud apps, today announced a partnership with Inflectra, a provider of software development and testing tools.

Continuous Validation March 2017 Newsletter

*|MC:SUBJECT|*
Continuous Validation March 2017 Newsletter


Newsletter
March 2017
"Continuous validation is providing documented evidence to certify that a cloud app not only met the pre-established acceptance criteria, but “continuous” to meet thus mitigating the risk of unknown changes."
Be Informed
CONTINUOUS QUALIFICATION FOR AWS OR MICROSOFT AZURE - HOW IS IT DONE?

The 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.

Does this mean that the Life Science world should stay in the dark ages with their paper based, wet signature toolset and a brick and mortar data center? You need continuous Qualification for Continuous Compliance that works better than ever, just like the Cloud!

Here is a step by step guide to Continuous Qualification:

  1. Step 1: Design your BASE Cloud Infrastructure (combination of IaaS / PaaS)

  2. Step 2: Divide your BASE into logical Services

    1. Core Services (e.g. Networking, Compute)

    2. Management Services (e.g. Auditing, Monitoring)

  3. Step 3: Build your DEV BASE IaaS/PaaS. Finalize and test your configuration.

  4. Step 4: Develop a Qualification Plan / Governance Framework

  5. Step 5: Subscribe to our IaaS / PaaS Qualification Service. We have built a sophisticated infrastructure to qualify Microsoft Azure or AWS Services. Our Service Qualification coverage is unmatched. We post the following on a "Weekly" basis on our customer portal:

    1. Service Qualification Plan

    2. Service Requirements Specification (with Comprehensive Coverage)

    3. Service Risk Assessment

    4. Service Qualification Protocols & Execution Reports

    5. Service Qualification Summary Reports

    6. Service Release Certificates

  6. Step 6: You don't have to Qualify any Service. We will do that for you on a continuous basis. Our "continuous" qualification platform for each Service will provide documented evidence that your Service continuous to work as designed (irrespective of many changes pushed by the Cloud Vendor)

  7. Step 7: Deploy PROD BASE IaaS/PaaS

  8. Step 8: Add or Modify Services to build out your Cloud under Change Control

Be More Informed

CONTINUOUS VALIDATION - HOW IS IT DONE? - PART 1: INFRASTRUCTURE Read More -->

CONTINUOUS VALIDATION - HOW IS IT DONE? - PART 3: PROCESS FLOW Read More -->

CONTINUOUS VALIDATION - HOW IS IT DONE? - PART 2: VALIDATION Read More -->

xLM has introduced "eXtreme", "agile" and "continuous" validation life cycle management that is rigorous enough to meet FDA, EMA regulations and at the same time cost effective. Read More -->
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Continuous Qualification for AWS or Microsoft Azure - How is it done?

Continuous Qualification for AWS or Microsoft Azure - How is it done?

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.