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Project Scope

Cloud technology and its use of multi-tennant app solutions are increasing the capabilities of Life Sciences solutions and reducing IT infrastructure costs through the sharing of infrastructure and investment cross-industry.

In some areas multi-tenant cloud solutions have become ubiquitous. For example, Salesforce.com claim >150K customers utilize their platform for Customer Relationship Management. Furthermore, many routinely rely on cloud services associated with their computer backups and data services associated with cell phones.

Nonetheless, the perceptions and interpretations of the regulations by which the life sciences industry must conduct its business still leave many uncertain about whether or not they can - or should - pursue the use of cloud solutions for GxP applications.

The goal of this work stream has been to provide a practical, usable framework to overcome those barriers. Through the use of this framework, it is envisaged that the barriers to adoption by pharma of cloud-based technology will be addresses.




Project LeadsEmail

Anders Vidstrup

avid@nnit.com

Wendy Dobson (PHUSE Project Manager)

wendy@phuse.global


Deliverables

Timelines

Finalise Chapters and send for internal reviewQ12021
Publish final frameworkQ12021


  • Breakout sessions at CSS
  • Bi-weekly meetings debating/review document
  • Going virtual has had impact on the progress of project
  • Status
    colourBlue
    titleCurrent Status
     Q42020

     Q42021

    • Draft of 2 appendix ongoing and will be shared with project members for feedback in Mid Decemberby end of April
    • Will consolidate and then update the appendix


    The team has representatives from SaaS, PaaS and IaaS providers as well as 'consumer organisations' Stakeholders. This workstream has generated value for several levels of stakeholders

    • For the wider audience - interested in knowing what is possible in cloud computing - it has generated use cases that illustrate the successful implementations, or pitfalls, in the use of cloud-based technology

    • For IT professionals it has generated information materials that help to guide efforts to implement quickly, and in regulatory compliance, cloud technologies as well as providing decision trees to support technology decision making

    • For the regulatory professionals, it provides a clear mapping between technology capabilities and regulatory requirements


    Resources

    Cloud Adoption - Framework Documents: Version 4.0, 24-Apr-2019

    • To include, Pre Amble, Audit Activities, Regulatory Requirements, Terminology

    Cloud Webinar Nov18.pdf




    Project Members

    Company

    Anupama SheoranBayer
    Bob StreitJanssen Research & Development
    Catherine LiFDA
    Chris WhalleyIndustry
    Dan DziadiwMerck, Sharp & Dohme
    Evi CohenAppian
    Eunice NdunguMerck, Sharp & Dohme
    Hans Peter-SchreiterEntimo
    Lynn CaldwellPfizer
    Martijn Van BeelenGSK
    Andrew MattesonApplied Biomath
    Pieter StasBusiness & Decision Life Science
    Raechelle RaimondoAllergan
    Richard MartinezRHO World
    Rocco TimpanoPfizer
    Sandy EstradaCervello
    Serena PiersonAccenture
    Stuart WardIDBS
    Suzanne StudingerQAS AG
    William TelfordSanofi