Infrastructure Qualification

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Infrastructure Qualification

Consulting Services

professional services and assessments

VISTX provides transformation, cloud compliance as well as infrastructure qualification and strategy services tailored specifically for life sciences organizations.   Our team of seasoned professionals take a holistic approach – operations, technical and compliance – to help drive organizational change and deliver unsurpassed results.

While our competitors are writing books,
VISTX is delivering RESULTS!

Infrastructure Qualification Overview

The life sciences industry has become increasingly dependent on computer systems to run  its business. With the increasing reliance on the Cloud models collectively known as XaaS)

  • IaaS – Infrastructure as a Service – A vendor provides clients pay-as-you-go access to storage, networking, servers, and other computing resources in the cloud.
  • PaaS – Platform as a Service – A service provider offers access to a cloud-based environment in which users can build and deliver applications. The provider supplies underlying infrastructure.
  • SaaS – Software as a Service – A service provider delivers software and applications through the internet. Users subscribe to the software and access it via the web or vendor APIs.

iMaintaining control over our infrastructure and applications is essential.   In fact, regulatory agencies are, in some cases, requiring that Infrastructure be qualified.

Vector image of quotation marks
Per GAMP Guidance

IT Infrastructure should be brought into initial conformance with the regulated company’s established standards. This can be achieved through a planned qualification (specification and verification) process, building upon recognized industry good IT practices. Once in conformance, this state should be maintained by documented standard processes/procedures and quality assurance activities

Qualification is meant to provide evidence that the infrastructure:

  • Meets the specification
  • Has the procedures in place to ensure the system remains under control
  • Is suitable for its intended use.

Bottom line:  You need to Qualify your infrastructure regardless of where the services are located.  That said, it is important that we utilize a process that is efficient while meeting the objectives of qualification.

Our proven approach was designed to ensure that the process is efficient and cost-effective while maintaining compliance with regulations,  guidance and industry best practices throughout the lifecycle.

PHASE I - Laying the foundation

Discovery

Strategy

Governance

During the Discovery Phase, we review  current procedures, discuss future objective and review requirements for Infrastructure Qualification.

Our Strategy Phase outlines the activities to Qualify the Infrastructure and ensure that the environment  remains under control.

Our Governance Phase outlines the requirements for compliance.  SOP’s, Work Instructions, Forms, etc.  

Infrastructure Qualification Discovery

Our Discovery activities determine the best path to drive maximum results. As part of the process, we partner with you to help determine your objectives, culture and capabilities   Key activities include:

  • Identification of  key stakeholders
  • Assessment of current state and architecture
  • Create an Application Catalog
  • Review current, approved procedures

Information Qualification Strategy Development

Taking the input from the Discovery Phase, VISTX partners closely with you to develop a Plan and Roadmap for deploying your new Infrastructure Qualification Model

How will we qualify our infrastructure?  What controls need to be in place?  What are the governing SOPs?  Are there any tools that can help automate the process?

VISTX helps complete the assessment, asking the right questions and make sure

Key activities include:

  • Create Plan and Roadmap


The Plan should be based on your culture, risks, capabilities and resources along with industry best practices.

Components of a good plan

  • Executive Summary
  • Introduction
  • Results of Discovery
  • Background
  • Qualification Approach
  • Roles and Responsibilities
  • Deployment Schedule
  • Risks and Mitigation Strategy

Are your compliance practices supporting your business??

Infrastructure Qualification Governance model

This phase prepares the organization for your Infrastructure Qualification program.  It should include:

  • Developing and approving new forms
  • Developing and approving SOPs and Work Instructions
  • Developing and approving any Procedures or Policies required for operating and maintaining the environment
  • Training organization on new procedure

VISTX has extensive experience helping our clients implement new processes and update existing processes to maximize value and minimize risk.

This model must includes assurance that all processes and procedures are in place, to control tp maintain control throughout.

VISTX has extensive experience helping our clients implement new processes and update existing processes to maximize value and minimize risk.

Phase II - Qualify the infrastructure

Build and Qualify

Plan

Specification and Design

Build

Qualify

This first step in the Qualification Process is to create your Qualification Plan.  The Qualification Plan should include:

  • Objective
  • Background
  • Scope
  • Roles and Responsibilities
  • High-level Architecture Diagram
  • Deliverables
  • Qualification Approach

The next step is to do a Risk Assessment.

Note:  In some circumstances, you might include this as part of your Infrastructure Qualification procedure.

The specification and design is what we use as the baseline for “built as intended.”  

Our typical approach is to create a request form that can serve as the specification.  

The Design is usually documented by an Architecture Diagram.

Using any available automation, build the infrastructure as soecufued un the. Request Form.

Automated tools allow you to rely on the Vendor Assessment and previous testing to reduce the overall effort of the testing process as well as minimize the risk.

Execute your Qualification Form or Protocol and gather the evidence.  

Submit the package for Quality approval.  

 

 

operating and maintaining

governance

Application Validation

continuous Validation

Have a question or need some advice?
Request a free consultation.

Phone: (469) 908 – 4789
Email: info@vistx.com

Address: 6424 E. Greenway Plwy. Suite 100, Scottsdale, AZ. 85254

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