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Capabilities Overview

Consulting Services

professional services and assessments

Our professional consultants offer unmatched domain, technical and compliance expertise. While the other consulting firms are writing books, VISTX is delivering results.

who we are

Explore VISTX Expertise

Operations

Discover how VISTX can help transform your operational procedures.

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Technical

Speed, cost, security and innovation are just a few of the promises of the Cloud. Let VISTX help you realize these a, and other, benefits and create real value for your clients.

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Compliance

Click edit button to change this text. Lorem ipsum dolor sit amet, consectetur adipiscing elit. From qualifying your infrastructure to validating your application, VISTX has the expertise and experience to help.

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Consulting services

VISTX provides consulting services tailored specifically for life sciences organizations.   Our team of professionals has extensive experience in driving organizational change while  while implying with regulations, guidances and best practices.

Operations

Business Transformation

Workflow Review and Approval Transformation

Program ans Projecr Management

Business Performance Transformation is the adoption of  technology to transform services or businesses.  This is done by replacing non-digital or manual processes with digital processes or replacing older technology with newer  technology.

Digital solutions may enable – in addition to efficiency via automation – new types of innovation and creativity, rather than simply enhancing and supporting traditional methods

For life sciences organizations, the document review and approval lifecycle can be a time-consuming 

And given the number of documents – validation documents, SOPs,and many more – reducing the cycle time can have a tremendous impact.

VISTX helps clients deploy new processes and technology that can reduce the cycle time by 90%

Energize your project management with strategic and tactical project management office that seamlessly works with existing resources to enhance IT efficiency and reduce costs.

Technical

GxP Migration to the Cloud

Cloud Transformation

Data Migration

Moving your GxP applications and data to the Cloud can offer tremendous benefits.  Including:

  • Enhanced Security
  • Increases flexibility, agility and innovation
  • Reduced risk
  • Reduced costs

Moving to the Cloud or migrating legacy applications to the Cloud is, obviously, much more involved in a GxP environment.  There are may things to consider from Infrastructure Qualification to maintaining control of your Cloud environment after your migrat9n is complete. These activities ake much more rigor and control than a more traditional non-GxP environment.  

That said, most organizations treat the Cloud like they treat an on-premise solution.  In order to have a 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 . 

VISTX has experience with these types of transformations and can help you make the best decisions for your organization based on your objectives and culture. 

Taking advantage of the Cloud to the Cloud is much more involved in a GxP environment.  New procedures and to existing procedure need to be put in plac3 to make sure your new environment is qualified during the build process and stays under control throughout the lifecycle of the system.  VIISTX can help set up automation and controls to make make sure you re in complianceThere are may things to consider from Infrastructure Qualification to maintaining control of your Cloud environment after your migrat9n is complete. These activities ake much more rigor and control than a more traditional non-GxP environment.  

That said, most organizations treat the Cloud like they treat an on-premise solution.  In order to have a 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 . 

VISTX has experience with these types of transformations and can help you make the best decisions for your organization based on your objectives and culture. 

Moving regulated content and data in a GxP environment presents a unique set of challenges.  Making sure the migration has the proper controls in place and ensuring that the testing strategy and execution are compliant, is critical to migrating your legacy data to a 21CFR Part 11 compliant application.

Compliance

“Qualification” documents that the computer system is suitable for it’s intended use.  It is important that we perform this actiity to do exacly that.  Unfortunatrloy, most life sciences organizations make this a cumbersome process.  Since infrastructure is generally considered low risk, it is important that we utilize a process that is efficient, meets the existing procedures and documents that is infrastructure meets the specifications.  To accmplish this, there are 3 tyoes of approaches.

Whether you have limited in-house expertise or you simply want to supplement your existing staff, VISTX has the expertise to help you reach your goals.

Benefits of our on Computer System Validation Service include:

  • Knowledge and experience—VISTX has delivered over 50 Validation projects >with many different software packages.  
  • Current compliance best practices—we  keep in tune with the latest regulations and “best practices”constantly update our body of industry “best practices,” in order to see our clients up-to-date with the ever-changing regulatory requirements.
  • Reduced validation time and cost —our experienced project managers and validation leads can expedite the process =, getting your system in prduction quicker, saving you time and money.

With increased regulatory pressure and operational complexity, as well as a widening gap between external demands and internal capabilities, traditional approaches to Compliance are no longer fit for the future. This is reflected in our 2019 Compliance and Risk Study. Regulations are getting tougher, budgets tighter and the price of compliance is growing. Plus, Compliance leaders are expected to proactively identify new risks and to support sustainable business growth.

As Compliance’s role shifts from reactive to strategic, its responsibilities are expanding to include risk management and enterprise-wide advisory services. The result: Compliance leaders need to redesign their operations for the future.

By moving compliance related functions to an intelligent operating model, you will be able to cost effectively keep pace with regulatory demand, provide strategic guidance, and drive sustainable growth.

21CFR Part 11 Assessments

Cloud Vendor Audit

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How we can help

GxP Migration to the Cloud

VISTX helps clients plan and execute their GxP Migration to the Cloud - improving their chances of success and minimizing risk.

Services include: ;

  • Assessment of current state
  • Planning for future state
  • GxP Application Migration Planning
  • Development of Migration Plan and Roadmap
  • Vendor Audit
  •  Governance Planning and Strategy
  • Development of SOP, Work Instructions and Procedures
  • Business Transformation

    Technology is enabling new operating models

    And...VISTX is a leader in implementing new technologies and driving operational improvements. Services include:
  • Process Improvement Strategy
  • Design, development and deployment of new technology
  • Change Management for better adoption
  •  Governance strategy and models
  • Infrastructure Qualification Per Industry guidance, ALL Infrastructure should be Qualified.  With the implementation of new models (Infrastructure- as-a-Service - IaaS), qualifying infrastructure becomes much more challenging.  With an ever-changing infrastructure, how do we maintain and demonstrate control? VISTX has extensive experience in designing and implementing new procedures for qualifying infrastructure in a cost-effective manner.  

    Services include:

  • Development of strategy and governance models
  • Design and implementation of new procedures
  • Computer System Validation


    Whether you have limited in-house expertise or you simply want to supplement your existing staff, VISTX has the expertise to help you reach your goals.


    Benefits of our on Computer System Validation Service include:


    • Knowledge and experience—VISTX has delivered over 50 Validation projects >with many different software packages.  
    • Current compliance best practices—we  keep in tune with the latest regulations and "best practices"constantly update our body of industry “best practices,” in order to see our clients up-to-date with the ever-changing regulatory requirements.
    • Reduced validation time and cost —our experienced project managers and validation leads can expedite the process =, getting your system in prduction quicker, saving you time and money.



    Typical  Validation Package includes:


    <liValidation plan

    • System risk assessment report
    • User requirements specification
    • System configuration specification
    • Test plan
    • Installation Qualification (IQ) testing and results
    • Operation Qualification (OQ) testing and results
    • Performance Qualification (PQ) testing and results< /li>
    • Traceability matrix
    • Quality assurance review
    • Validation summary report
    • Review of Standard Operating Procedures (SOPs)
    • Technical and Compliance support
    • Assessment for compliance with 21CFR Part 11)

     

    Program and Project Management

    Project Management tailored to your situation.

    When we named VISTX, the acronym stated for "Where Vision and Strategy Meet Execution."

    As such,  Project Management is one of our core capabilities.

    Our seasoned project manages have successfully lead projects of varying size.  

    From large-scale, enterprise-wide projects to small project teams deploying front-line initiatives.

    When we named VISTX, the acronym stated for "Where Vision and Strategy Meet Execution."

    As such,  Project Management is one of our core capabilities.

    Our seasoned project manages have successfully lead projects of varying size.  

    From large-scale, enterprise-wide projects to small project teams deploying front-line initiatives.

    Whether you have a project in need, require an audit of your project or need someone towel you develop and deploy new procedures, tools and training, VISTX has the expertise to help you reach your goals.

    Whether you have a project in need, require an audit of your project or need someone towel you develop and deploy new procedures, tools and training, VISTX has the expertise to help you reach your goals.

    Data Migration

    Moving regulated content and data in a GxP environment presents a unique set of challenges.  Making sure the migration has the proper controls in place and ensuring that the testing strategy and execution are compliant, is critical to migrating your legacy data to a 21CFR Part 11 compliant application..

    With over 30 Million records migrated, VISTX has the knowledge, experience and methodology to deliver consistent and compliant results that our clients have come to expect

    Frequently Asked Questions

    Most frequent questions and answers

    Do I need to Qualify the Infrastructure?

    The answer is “yes”.  Per GAMP guidelines, ALL Imfrastructure should be Qualified.  You may even want to consider qualifying your non-GxP Infrastructure as well.

    Do I need to Validate my computer system?

    If the computer system is used in a GXP process or used to make decisions on a GxP process or  stores electronic records, you need to validate the system

    What is Business Transformation?

    Business Performance Transformation is the adoption of  technology to transform services or businesses, through replacing non-digital or manual processes with digital processes or replacing older digital technology with newer digital technology. Digital solutions may enable – in addition to efficiency via automation – new types of innovation and creativity, rather than simply enhancing and supporting traditional methods.

    Does AccelDocs and LabAccel comply with 21CFR Part 11?

    Yes.  AccelDocs and LabAccel comply with 21CFR Part 11 for Electronic Records, Electronic Signatures and Audit Trails.

    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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