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Redefining validation....continuously!

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Featured
xLM for DevOps - Introducing vCD (Validated Continuous Delivery)
xLM, continuous validation, Test Automation, DevOps, vCD, validated continuous delivery
xLM for DevOps - Introducing vCD (Validated Continuous Delivery)
xLM, continuous validation, Test Automation, DevOps, 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?

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xLM, continuous validation, Test Automation, DevOps, vCD, validated continuous delivery
xLM App for ServiceNow is available in the NOW Store...
partnership
xLM App for ServiceNow is available in the NOW Store...
partnership

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.  

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partnership
Continuous Validation for ServiceNow - HOW IS IT DONE?
servicenow, continuous validation, Cloud Qualification, xLM
Continuous Validation for ServiceNow - HOW IS IT DONE?
servicenow, continuous validation, Cloud Qualification, xLM

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.

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servicenow, continuous validation, Cloud Qualification, xLM
ServiceNow: Data Integrity Guide for GxP Compliance - Tables
servicenow, continuous validation, data integrity, audit trail, xLM
ServiceNow: Data Integrity Guide for GxP Compliance - Tables
servicenow, continuous validation, data integrity, audit trail, xLM

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?

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servicenow, continuous validation, data integrity, audit trail, xLM
A Step-by-Step Guide to "continuously" Qualify Microsoft Azure PaaS and Serverless Architectures
continuous validation, azure qualification, xLM, managed service, IT Infrastructure Qualification
A Step-by-Step Guide to "continuously" Qualify Microsoft Azure PaaS and Serverless Architectures
continuous validation, azure qualification, xLM, managed service, IT Infrastructure Qualification

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). 

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continuous validation, azure qualification, xLM, managed service, IT Infrastructure Qualification
A Step-by-Step Guide to "continuously" Qualify Azure
azure qualification, continuous validation, xLM, managed service, IT Infrastructure Qualification
A Step-by-Step Guide to "continuously" Qualify Azure
azure qualification, continuous validation, xLM, managed service, IT Infrastructure Qualification

The 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. 

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azure qualification, continuous validation, xLM, managed service, IT Infrastructure Qualification
A Step-by-Step Guide to "continuously" Qualify AWS
AWS Qualification, continuous validation, IT Infrastructure Qualification, managed service, xLM
A Step-by-Step Guide to "continuously" Qualify AWS
AWS Qualification, continuous validation, IT Infrastructure Qualification, managed service, xLM

The 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.   

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AWS Qualification, continuous validation, IT Infrastructure Qualification, managed service, xLM
How are you fulfilling the FDA's Audit Trail expectations for Data Integrity?
continuous validation, audit trail, data integrity
How are you fulfilling the FDA's Audit Trail expectations for Data Integrity?
continuous validation, audit trail, data integrity

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.

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continuous validation, audit trail, data integrity
Continuous Validation for Track & Trace Enterprise Application
continuous validation, Validation, Cloud Qualification, Why xLM?
Continuous Validation for Track & Trace Enterprise Application
continuous validation, Validation, Cloud Qualification, Why xLM?

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....

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continuous validation, Validation, Cloud Qualification, Why xLM?
Inflectra, xLM Partner to Deliver continuously validated Spira Team Apps
partnership
Inflectra, xLM Partner to Deliver continuously validated Spira Team Apps
partnership

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.

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partnership
Continuous Validation March 2017 Newsletter
continuous validation
Continuous Validation March 2017 Newsletter
continuous validation
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continuous validation
Continuous Qualification for AWS or Microsoft Azure - How is it done?
Cloud Qualification, IT Infrastructure Qualification, Why xLM?, AWS Qualification, azure qualification
Continuous Qualification for AWS or Microsoft Azure - How is it done?
Cloud Qualification, IT Infrastructure Qualification, Why xLM?, AWS Qualification, azure qualification

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.

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Cloud Qualification, IT Infrastructure Qualification, Why xLM?, AWS Qualification, azure qualification
Continuous Validation - How is it done? - Part 3: Process Flow
Cloud Qualification, continuous validation, Why xLM?
Continuous Validation - How is it done? - Part 3: Process Flow
Cloud Qualification, continuous validation, Why xLM?

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

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Cloud Qualification, continuous validation, Why xLM?
CONTINUOUS VALIDATION - HOW IS IT DONE? - PART 2: VALIDATION
continuous validation, Cloud Qualification, IT Infrastructure Qualification, Test Automation, Validation, xLM
CONTINUOUS VALIDATION - HOW IS IT DONE? - PART 2: VALIDATION
continuous validation, Cloud Qualification, IT Infrastructure Qualification, Test Automation, Validation, xLM

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.

Read More →
continuous validation, Cloud Qualification, IT Infrastructure Qualification, Test Automation, Validation, xLM
Continuous Validation - How is it done? - Part 1: Infrastructure
continuous validation, Test Automation, xLM, Cloud Qualification
Continuous Validation - How is it done? - Part 1: Infrastructure
continuous validation, Test Automation, xLM, Cloud Qualification

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.

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continuous validation, Test Automation, xLM, Cloud Qualification
Continuous Validation November 2016 Newsletter
continuous validation
Continuous Validation November 2016 Newsletter
continuous validation
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continuous validation
xLM's Service Based Accretive GxP Qualification Model for Cloud Infrastructure
Accretive Model, IT Infrastructure Qualification, Cloud Qualification, AWS Qualification, azure qualification
xLM's Service Based Accretive GxP Qualification Model for Cloud Infrastructure
Accretive Model, IT Infrastructure Qualification, Cloud Qualification, AWS Qualification, azure qualification

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....

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Accretive Model, IT Infrastructure Qualification, Cloud Qualification, AWS Qualification, azure qualification
Combinatorial Testing: A Key Element in Software Validation
continuous validation
Combinatorial Testing: A Key Element in Software Validation
continuous validation

Combinatorial Testing must be an integral part of software validation because it not only reduces cost but increases the efficacy of your test strategies.   This is even more important since the complexity of software apps are increasing exponentially.

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continuous validation
continuous validation, managed service, IT Infrastructure Qualification, Cloud Qualification
How to "Validation Enable" the Cloud?
continuous validation, managed service, IT Infrastructure Qualification, Cloud Qualification

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? 

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continuous validation, managed service, IT Infrastructure Qualification, Cloud Qualification
Continuous Validation October 2016 Newsletter
continuous validation
Continuous Validation October 2016 Newsletter
continuous validation
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continuous validation
continuous validation, managed service
Dashboards & Metrics: A Clear Window into Real-time Validation
continuous validation, managed service

Most important and time consuming piece of any validation stack are test scripts (Installation, Operational, Performance, etc..), test executions and test results.  Validation is all about authoring test scripts, executing and documenting test results.   Whether testing is manual or automated, a lot of data is collected during validation.  Only in rare cases, one will be able to obtain real-time data on test execution, testing deviations or test coverages.  Such information will enable more efficient management of validation efforts and reduce costs.  A well designed system will provide useful dashboards and metrics to project managers as well as validation personnel.

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continuous validation, managed service
 Continuous Validation September 2016 Newsletter
continuous validation
Continuous Validation September 2016 Newsletter
continuous validation
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continuous validation
Cloudbyz, xLM Partner to Deliver 'continuously' validated Cloudbyz CTMS
partnership
Cloudbyz, xLM Partner to Deliver 'continuously' validated Cloudbyz CTMS
partnership

PHILADELPHIA, PA (PRWEB) SEPTEMBER 07, 2016

xLM, LLC, the first managed service provider for delivering continuously validated cloud apps, today announced a partnership with Cloudbyz, a provider of eClinical apps.

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partnership
ServiceMax, ValiMation Partner to Deliver “continuously” validated Field Service Management Solution
partnership
ServiceMax, ValiMation Partner to Deliver “continuously” validated Field Service Management Solution
partnership

Philadelphia, PA, August 19, 2016 – ValiMation, Inc., the first managed service provider for delivering continuously validated cloud apps, today announced a partnership with ServiceMax, the leader in cloud-based field management solutions, to provide customers with complete validation life-cycle management for all ServiceMax apps.

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partnership
What are technical details of xLM Managed Validation Service?
continuous validation, managed service
What are technical details of xLM Managed Validation Service?
continuous validation, managed service

Validation Lifecycle Management

  1. “No Paper” Validation Infrastructure
  2. No Longer Limited to “Point in Time” Validation
  3. Manage Requirements, Specifications, Test Plans & Test Cases, Test Failures
  4. Manage Testing Schedules
  5. Manage Test Sequencing
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continuous validation, managed service
continuous validation, Why xLM?
Why should you select xLM as the Validation Service Provider for your Cloud App?
continuous validation, Why xLM?

Compliance & Validation

xLM managed service is designed for Cloud App Validation.   It is a validated automated test platform to “certify” your cloud app.  This certification can include:

  1. Initial Validation
  2. Patch & Upgrade Validation
  3. Regression Testing
  4. New Feature Testing
  5. Performance Testing
  6. Security Testing
  7. Continuous Validation (a unique and bonus feature)
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continuous validation, Why xLM?
continuous validation
xLM - Continuous Validation - A Managed Service
continuous validation
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continuous validation
Test Automation, Case Study, Publication
A New Platform in Computer Validation: Automated Testing Tools and Requirements Management - Published in Data Basics
Test Automation, Case Study, Publication
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Test Automation, Case Study, Publication
Risk Based Validation, ERP, Case Study, Publication
A Risk-Based Approach to ERP Systems Validation - Published in PDA Letter
Risk Based Validation, ERP, Case Study, Publication
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Risk Based Validation, ERP, Case Study, Publication
Beyond “Dumb”: Building a Paperless, Web 2.0 Validation Platform
Paperless Validation, 21 CFR Part 11
Beyond “Dumb”: Building a Paperless, Web 2.0 Validation Platform
Paperless Validation, 21 CFR Part 11

“We are living in an era of ‘dumb’ content,” says consultant Nagesh Nama, President of ValiMation, Inc., and who spoke at DIA 2010 in Washington, DC. [Note: Nama's talk preceded that by Novartis' Jim McElroy, featured in yesterday's post on "The Paperless Validation
Lifecycle."].

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Paperless Validation, 21 CFR Part 11
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