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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

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

Life Sciences industry must conduct its business still leave many uncertain about whether or not they can

-

(or should

-

) pursue the use of

cloud

Cloud solutions for GxP applications.

The goal of this

work stream

project 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

Pharma of

cloud

Cloud-based technology will be

addresses

addressed.



Project LeadsEmail

Anders Vidstrup, NNIT

avid@nnit

anders@vidstrup.

comWendy Dobson (

dk

Alex Pearce, PHUSE Project
Manager)
Assistant
wendy@phuse

Alexandra@phuse.global

Deliverables

Timelines

Finalise Chapters and send for internal reviewQ12021Publish final frameworkQ12021


Status
colourBlue
titleCurrent Status

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

    • Q1 2024 

    This quarter, the definition of the term exit strategy must be in place including the main structure of the document. Sub-chapters to be assigned to group members

    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'

     StakeholdersThis workstream

     Stakeholders. This project has generated value for several levels of stakeholders.

    • For the wider audience

    -

    • interested in knowing what is possible in

    cloud

    • Cloud computing

    -

    • , it has generated use cases that illustrate the successful implementations, or pitfalls, in the use of

    cloud

    • Cloud-based technology.

    • For IT professionals it has generated information materials that help to guide efforts to implement quickly, and in regulatory compliance,

    cloud

    • 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

    • .



    Objectives & Deliverables

    Timelines

    Updated main document - Preamble Q3 2022


    Published Deliverables

    Cloud Framework – Audit Activities

    		1-Jul-2022

    Cloud Adoption

    -

    – Framework Documents: Version 4.0

    , 24-Apr-2019

    • To include,

    Pre Amble

    • Preamble, Audit Activities, Regulatory Requirements, Terminology

    Cloud Webinar Nov18

    • .

    pdf

    Project Members

    Company

    Anupama SheoranBayerBob StreitJanssen Research & DevelopmentCatherine LiFDAChris WhalleyIndustryDan DziadiwMerck, Sharp & DohmeEvi CohenAppianEunice NdunguMerck, Sharp & DohmeHans Peter-SchreiterEntimoLynn CaldwellPfizerMartijn Van BeelenGSKAndrew MattesonApplied BiomathPieter StasBusiness & Decision Life ScienceRaechelle RaimondoAllerganRichard MartinezRHO WorldRocco TimpanoPfizerSandy EstradaCervelloSerena PiersonAccentureStuart WardIDBSSuzanne StudingerQAS AG

    		24-Apr-2019

    Cloud Framework, Pre-Amble

    		27-Nov-2023
    William TelfordSanofi