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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.eu

Deliverables

Timelines



The team has representatives from SaaS, PaaS and IaaS providers as well as 'consumer organisations' StakeholdersThis 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

Bob StreitJNJ
Catherine LiFDA
Chris WhalleyIndustry
Dan DziadiwMerck
Evi CohenAppian
Eunice NdunguMerck
Hans Peter-SchreiterEntimo
Lynn CaldwellPfizer
Martijn Van BeelenGSK
Andrew MattesonApplied Biomath
Pieter StasBDLS
Raechelle RaimondoAllergan
Richard MartinezRHO World
Rocco TimpanoPfizer
Sandy EstradaCervello
Serena PiersonAccenture
Stuart WardIDBS
Suzanne StudingerIndustry
William TelfordSanofi
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