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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

CURRENT STATUS Q42020

  • Breakout sessions at CSS
  • Bi-weekly meetings debating/review document
  • Going virtual has had impact on the progress of project
  • Draft of 2 appendix ongoing and will be shared with project members for feedback in Mid December

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
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