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

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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 It is not possible to qualify an infrastructure where changes are released without release notes with such an outdated mindset and toolset.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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Our mailing address is:
1055 Westlakes Drive, Suite 300, PA 19312, USA


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.

CONTINUOUS VALIDATION - HOW IS IT DONE? - PART 2: VALIDATION

CONTINUOUS VALIDATION - HOW IS IT DONE? - PART 2: VALIDATION

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.

Dashboards & Metrics: A Clear Window into Real-time Validation

Dashboards & Metrics: A Clear Window into Real-time Validation

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.

Charts and Graphs for Bulletproofing Your GxP Compliant Reports

Charts and Graphs for Bulletproofing Your GxP Compliant Reports

In the GxP world, test execution reports for any validation exercise contain most important artifacts that serve as evidence.  Audit trail of 'who did what? at what time?' are captured in the form of actions and results with time stamps, and most frequently with screenshots.  In most test automation frameworks that are utilized in validation, a major gap is the presentation of this evidence that can meet the scrutiny of any inspector. 

How To Setup a Validated Test Automation Solution For Cloud Applications

How To Setup a Validated Test Automation Solution For Cloud Applications

Life science companies would love to get rid of inefficient and costly validation processes, may it be electronic manual tests or even worst, paper based manual tests.  The only answer to this problem is "test automation".  But the challenge is that if you use test automation for validation, then you need to keep your test automation infrastructure and processes also in a validated state.  But the test automation world is too complex for validation and even more difficult to keep it in a validated state given the nature of frequent changes, upgrades and a myriad of tools used.

Model Based Testing - A New Benchmark in Test Automation

Model Based Testing - A New Benchmark in Test Automation

Test Automation field is evolving with unprecedented pace to avoid pitfalls and overcome challanges of design complexity, selecting appropriate tools, agility and efficiency. Model Based Testing (MBT) could be a breakthrough for the industry as MBT tools now offer comprehensive solution for integrated test design and automation. At xLM, we have unearthed MBT solutions that overcome most challenges faced in traditional test automation.