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GxP Cloud Part 6 of 6: You’ve Arrived

Operating in a regulated environment adds complexity to just about every layer of an organization.  From process definition, to tool selection, to training, to selecting vendors to work with.  The complications can be difficult to manage but working with the right partners offering the right solution set can alleviate a large portion of the headaches associated with regulatory compliance.   

Through a combined offering of Micro Focus subscription ALM and Tx3 Services’ Helios Qualified Hosting Platform and VERA Subscription for CSV, Life Sciences organizations now truly have an industry focused partner they can leverage to access an all in one, hosted, validation solution platform. 

Let’s start with the infrastructure offered via Helios.  It’s where everything will be residing, after all.  Aside from all the standard benefits of leveraging a hosted environment, Helios was specifically designed to host validated applications for Life Sciences companies.  In evaluating its viability as a cloud solution, prospective clients can be assured that the infrastructure they will be leveraging is set up and maintained with qualification standards in mind.  When audited, our customers have the ability to leverage our qualification documentation, as well as utilize us to provide audit responses. 

With the infrastructure concerns out of the way, let’s focus on the application side of things.  Micro Focus ALM has long been an established and heavily adopted solution in the Test Management space.  While it has all the modules and functionality any team would need for planning and executing tests or managing defects, it has lacked some industry specific components that Life Sciences teams require to manage their validation efforts in conjunction with their testing solutions.  This is where VERA comes into the picture. 

By adding VERA into ALM, customers now have a truly viable solution set to act as their system of record for all GxP related testing.  Complete with compliant workflow governance, configurable and dynamic approvals, traceability, audit history and 21 CFR Part 11 compliant electronic signatures, VERA for ALM enables a paperless, data-driven approach to CSV, removing the paper or electronic document from the equation.  All this functionality, by the way, is embedded directly into ALM so users don’t have to migrate between systems, truly allowing for a simplification of workflow and tool management. 

Wrapped altogether, and Tx3 customers will have access to: 

  • Dedicated, qualified environment 
  • Application control – customer dictates patch and version updates 
  • Full test management capabilities supporting both manual and automated testing 
  • Controlled, compliance workflow governance
  • Configurable review and approval workflow
  • 21 CFR Part 11 compliance electronic signatures
  • Full data capturing, audit history and reporting across the application validation lifecycle
  • Access to qualification and validation documentation

This all in one, subscription-based validation platform enables the simplification of complex qualification and CSV requirements.  From all sides of infrastructure, platform and solutions, Tx3 has been able to bring everything together to check all the boxes that Life Sciences organizations have generally struggled to find from a single vendor.  Teams working under FDA regulations can now fully leverage the benefits of reduced effort and cost of owning and maintaining internal infrastructure and application ownership while still ensuring that compliance is achieved. 

If you would like to learn more about this offering, please download the linked datasheet as well as our checklist, or feel free to reach out to info@tx3services.com and someone from the team will be in touch. 

Download our ROI of Hosting ALM in the Cloud here.

Download our “Compliance in the Cloud? Finding the Silver Lining for CSV” datasheet here.

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