xLM Continuous Validation Managed Service - FAQs


What is continuous validation?

The definition: "Continuous validation is providing documented evidence to certify that an app not only met the pre-established acceptance criteria, but “continuous” to meet thus mitigating the risk of unknown changes."
    
Continuous validation is not just a "point in time" validation.  It is a type of validation which connects various points in time (initial, patch, upgrade validation) with continuous smoke and regression testing.  This feature provides the documented evidence that the an app worked well not just at discrete points in time in the past, but continues to function as expected in the present.  This also mitigates the risk of any change in either the IaaS/PaaS layer (for cloud apps) or the underlying IT infrastructure (for on-prem apps) that can potentially alter its behavior.


How does "continuous" validation work?

Continuous Validation is GxP compliant and based on a sophisticated Model Based Testing Framework.   Once the Continuous Validation model is built, it can be used to perform initial validation as well as be run at regular intervals to "continuously validate" with no human intervention ("lights out mode").

 


What types of validation does continuous validation include?

    Continuous Validation can include:

  •     Initial Validation
  •     Patch & Upgrade Validation
  •     Regression Testing
  •     New Feature Testing
  •     Performance Testing
  •     Security Testing
  •     Continuous Validation (a unique and bonus feature)

Cloud Service Providers release changes constantly.  How will I maintain change control?

 

 

 

A true "cloud" is designed to constantly release changes so that the end customer can leverage these innovations and thus increase productivity.  However, this presents a dilemma for the traditional validation folks who are used to reviewing each change and then addressing it one way or the other.  

If you want to embrace the Cloud, the compliance perspective must change from examining every change by the Cloud Provider (which is practically impossible considering the velocity of changes) to ensuring your requirements are met constantly.  This can be achieved with the "continuous" validation framework where by you are constantly (for example:  daily) testing to ensure your requirements are met in spite of the changes.


Does xLM have a robust Quality Management System (QMS)?

 

xLM's QMS is based on industry standards as well as applicable GxPs.  xLM's QMS is a robust framework based on ISO 9001:2015, GAMP 5 and ASTM E2500 as well as FDA 21 CFR Part 11, EudraLex Annex 11.  xLM's QMS enables us to deliver our managed services that not only meets, but exceeds the expectations of regulatory agencies in the USA, Europe and Japan.


Is there a mapping of xLM's QMS to FDA's QSR?

xLM QMS's elements are mapped to 21 CFR 820 QSR.  Click here for details.


xLM has a 9 Step defined process flow.  Click here for more details.

How does xLM Managed Service Process Flow work?


xLM provides various KPIs and dashboards that provide a window into real-time validation.  Some examples are:

  •         Requirements to Test Case Heatmaps
  •         Test Execution Historical Graphs and KPIs
  •         Test Deviation KPIs and Dashboards

Click here to view some sample dashboard and KPIs.

Does xLM's service provide access to real-time KPIs and dashboards?


xLM has built-in support for multi-browser and multi-OS testing.

Can xLM support multi-browser testing?


xLM has built-in support to test all industry standard APIs including Web Services and REST APIs.

Can xLM support API testing?


Combinatorial Testing is an integral part of our continuous validation framework because it not only reduces cost but increases the efficacy of our testing strategies.   This is even more important since the complexity of software apps are increasing exponentially.  Click here for more details on this topic.

Why does xLM use combinatorial testing techniques?


xLM has developed an Accretive Model for Cloud Infrastructure Qualification.  Click here to access this accretive framework.

 

What is xLM's approach to Cloud Infrastructure (IaaS/PaaS) Qualification?


xLM fully supports IaaS/PaaS qualification of services provided by AWS and Azure.  It has developed an eight step framework.  Click here for more details.

Does xLM support qualification of AWS and Azure IaaS/PaaS Services?


Photo by Evan Dennis on Unsplash