GxP Cloud Transformation

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VISTX is a leading provider of GxP Cloud Transformation and GxP Cloud Compliance Strategy services to life sciences organizations. Our proven XPress Cloud Compliance Framework and real-world experience deliver unmatched results.

 

While other consulting companies are writing books, VISTX is delivering RESULTS!

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Discuss your needs and how VISTX can help

VISTX proven Approach

Results-driven Strategy + Efficiency + Compliance

Goals and Objectives

Current Procedures and Architecture

Migration Strategy

Governance Strategy

Roadmap

Automated

Procedures in Place

Move Apps and Data

Validate Applications

Moving to the Cloud or migrating legacy applications to the Cloud is, obviously, much more involved in a GxP environment.  There are many things to consider, but the primary consideration is to ensure your cloud environment is “under control” and you have the procedures in place to maintain the validated state of your applications.

 These activities in a GxP environment require more rigor than a non-GxP environment.  

That said, most organizations treat the Cloud like they treat an on-premise solution.  In order to have an efficient, cost-effective and successful migration, it is important to evaluate and manage the risk throughout the process.  Between the automated tools for the builds and the Infrastructure as a Service (IaaS) models, the environment is much different and must be treated as different.

VISTX has experience with these types of GxP Cloud Transformations and can help you identify the key areas, current gaps as well as assist you in making the best decisions for you. 

Discovery

Assess the Current and Future State

The Discovery Phase is a series of workshops designed to determine the current state of the organization and the desired future state.  Once these workshops are completed, the information is passed to the Strategy Phase.  Key activities include:
  • Identification of current key stakeholders
  • Identify Goals and objectives
  • Create Application Catalog
  • Assessment of current state and architecture
  • Review Current procedures

GxP Cloud Strategy

Formulate YOUR Cloud Strategy

Our Strategy activities determine the best path to drive maximum results from your migration and governance programs. As part of the process, we partner with you to help determine your objectives, culture and capabilities to formulate a strategy tailored to you. Key activities include:
Development of Migration Strategy – How will you move your current applications and data. There are many different terms for migration, but essentially there are 3 basic options:
  • Pick up and move “as is” (sometimes referred to as “Lift and Shift”).  Essentially, this is moving from one infrastructure to the new infrastructure with no changes. Changes, and thus, compliance requirements are minimized.  This is the simplest form of Migration.
  • Making changes to take advantage of the new architecture (sometimes referred to as “Improve and Move”).  Essentially, this is moving with some changes.
  • Major changes or replace (sometimes referred to as “Rip and Replace”). This is the most involved migration and requires much more compliance rigor.
Development of Governance Program Strategy – Developing your compliance strategy will, ultimately, determine the amount of effort and duration for your migration. You want to have enough rigor to ensure compliance, but you have to remember, the cloud is different.  You need well thought out procedures for Change Control, Configuration Management and other areas to ensure your environment is placed under control and remains under control.

GxP Cloud Planning

Develop your Plan and Roadmap

Developing your plan is one of the most critical activities, but is also one of the most often overlooked.  Most think go a plan as a schedule, but there should be more to your plan than just a list of activities and timeline.   You plan should also include:
  • Objectives
  • Scope (include applications to be migrated, if applicable)
  • Roles and Responsibilities
  • Qualification and Validation Approach
  •  Estimated costs
  • Risks and Mitigation Strategy
All in all, this document should describe, in full, what you are planning on doing, how you intend to accomplish this, how much it will cost and when will it be completed.

Build and Qualify

Automation and Efficiency

Use of automated tools during the Build process is a good way to improve efficiency, but it also reduces the risk associated with the build.  Reducing the risk reduces the amount of rigor required to Qualify the new component(s).  

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.

To accomplish this you should have the following:

  • Qualification Plan
  • Risk Assessment
  • Requirements/Specifications
  • Verification/Testing
  • Summary Report

Migration

Follow your Migration Strategy

Migration is the process of moving from one environment to another.  This could be from an on-premise solution to the Cloud or from one cloud environment to another cloud environment Our migration activities help make the process more efficient by apply automation and best practices to their Could migrations. We also incorporate automated testing  to ensure a successful migration and meet the regulatory guidelines and best practices.

Ensure your migration process
is under
control during the Migration.

For GxP, It’s not just about getting to the Cloud,
it's about maintaining control once you get there.

Computer system Validation

Once the Migration is complete, Validate your computer system to ensure it still works as intended inn the new environment.  For more information on Computer System Validation, see our Validation page.

Create a scalable, qualified Infrastructure and maintain the validated state of your applications

Innovation...strategic relationships...

Accelerated Results...

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