Difference between revisions of "Cloud Adoption in the Life Sciences Industry"

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=Lowering Barriers to the Adoption of Cloud Technology=
 
 
 
 
=Project Scope=
 
=Project Scope=
Cloud technology and multi-tennant cloud solutions are increasing the capabilities of Pharmaceutical R&D IT solutions and reducing Pharmaceutical R&D IT infrastructure costs through the sharing of infrastructure and investment cross-industry.
+
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 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 pharma industry must conduct its business still leave many in the industry uncertain about whether or not they can - or should - pursue the use of cloud solutions for GxP validated applications.
 
The goal of this workstream is to take small, concrete steps to determine where there are real barriers to the use of cloud-based solutions and where there are technical solutions to overcome those barriers.  Through the publication of use cases, best practices, and decision trees this group will lower the barriers to adoption by pharma of cloud-based technology, focus attention on areas of regulation that are causing the greatest concern, and focus industry investments on solving the major technical challenges that are outstanding.
 
  
== In Scope ==
+
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.
The use and the potential use of cloud-based systems to support business processes within the regulated domain of the biopharmaceutical industry
 
Data privacy regulation
 
Openly available technology solutions
 
  
== Out of Scope ==
+
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.
Commercial terms, internal company processes, vendor-specific products or solution
 
=Project Team Members=
 
List team leads and team members. Identification of a project manager is recommended.
 
  
=Project Team Members=
+
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 addressed.
A project team lead is needed.
 
A cross-functional team would be ideal for overall success with expertise across
 
*Cloud technology & IT infrastructure
 
*Systems Validation & Quality Assurance
 
*The Regulatory framework constraining pharma business processes
 
*Information Protection and IT Security
 
*Legal
 
*Patents
 
*Procurement
 
-R&D IT Applications Expertise
 
  
=Affected Stakeholder=
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= Project Leads  =
This workstream will generate value for serveral levels of stakeholder:
 
*For the wider audience - interested in knowing what is possible in cloud computing - it will generate use cases that illustrate the successful implementations or pitfalls in the use of cloud-based technology.
 
*For the IT professionals it will generate 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 will provide a clear mapping between technology capabilities and regulatory requirements.
 
  
=Project Meeting Frequency=
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{| class="wikitable" style="width:100%"
TBD – will depend on the number of participants, timelines, individual commitments, and team structures
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|-
 +
| Anders Vidstrup || Project Lead || NNIT || avid@nnit.com
 +
|-
 +
| Lauren White || Project Co-ordinator || PHUSE || lauren@phuse.eu
 +
|-
 +
|}
  
=Deliverables and Dates:=
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=Project Team Members=
{| class="wikitable"
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{| class="wikitable" style="width:100%"
 
|-
 
|-
! Objective!! Action !! Deadline
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| Bob Streit || Participant || JNJ || rstreit@its.jnj.com
 
|-
 
|-
| Use Cases|| a template will be defined and published by the end of August soliciting examples of successful validated cloud solutions. All use cases will be maintained [[Cloud Lowering Barriers Use Cases]]. ||August 2013
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|Catherine Li || Participant || FDA || Catherine.Li@fda.hhs.gov
 
|-
 
|-
| Regulatory Hurdles|| the team will publish a list of specific challenges in meeting regulatory requirements in multi-tenant cloud solutions.  The list of regulatory hurdles citing specific regulation and how this is challenging to groups validating multi-tenant, hosted solutions||September 2013
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| Chris Whalley || Participant || Industry || whalley@amazon.com
 
|-
 
|-
| Regulation to Technology Map || the team will publish a map connecting “regulatory requirements” to “purpose” to the variety of technical solutions that define best practices.|| October 2013
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| Dan Dziadiw || Participant || Merck || Daniel.Dziadiw@merck.com
 
|-
 
|-
| Technical hurdles || the team will publish a list of specific technical challenges which are currently unsolved with recommendations for how they could be addressed by a cross-industry group|| November 2013
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| Evi Cohen || Participant || Appian || Evi.Cohen@appian.com
 +
|-
 +
|Eunice Ndungu || Participant || Merck || eunice_ndungu@merck.com
 +
|-
 +
| Hans Peter-Schreiter || Participant || Entimo || hps@entimo.de
 +
|-
 +
|Lynn Caldwell || Participant || Pfizer || Linda.J.Thibeault@pfizer.com
 +
|-
 +
| Martijn Van Beelen || Participant || GSK || martijn.x.van-beelen@gsk.com
 +
|-
 +
|Andrew Matteson || Participant || Applied BioMath || andrew.matteson@appliedbiomath.com
 +
|-
 +
|Pieter Stas || Participant || Business & Decision Life Sciences || pieter.stas@businessdecision.com
 +
|-
 +
|Raechelle Raimondo || Participant || Allergan || raechelle.raimondo@allergan.com
 +
|-
 +
| Richard Martinez || Participant || RHO World || richard.martinez@rhoworld.com
 +
|-
 +
| Rocco Timpano || Participant || Pfizer || Rocco.b.Timpano@pfizer.com
 +
|-
 +
|Sandy Estrada || Participant || Cervello, a Kearney Company||sestrada@mycervello.com
 +
|-
 +
| Serena Peirson || Participant || Accenture || serena.peirson@accenture.com
 +
|-
 +
| Stuart Ward || Participant || IDBS || sward@idbs.com
 +
|-
 +
| Suzanne Studinger || Participant || Industry || suzanne.studinger@qas.works
 +
|-
 +
| William Telford || Participant || Sanofi || William.Telford@sanofi.com
 
|-
 
|-
| Information Refresh Process || the team will propose a specific approach to refreshing the content of its documentation as technology and regulatory environments evolve.  ||TBD
 
 
|}
 
|}
 +
<br>
 +
The team has representatives from SaaS, PaaS and IaaS providers as well as "consumer organisations". 
 +
 +
Further participation is always welcome - especially in the areas of:
 +
*Cloud technologies & IT infrastructure
 +
*Systems Validation & Quality Assurance
 +
*Regulations
 +
*Information Protection and IT Security
 +
*Legal
 +
*Procurement
 +
*R&D Applications Expertise
 +
*Training
 +
 +
=Stakeholders=
 +
This workstream has generated value for serveral levels of stakeholder:
 +
*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 the 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.
 +
 +
= Project Status =
 +
The third edition of the framework document has recently been created and is currently awaiting publication.  It is viewable at:
 +
 +
* [https://s3-us-west-2.amazonaws.com/phuse/public/PhUSE+Cloud+Doc+18-Nov-2016.pdf  (PDF) ]
 +
* [https://s3-us-west-2.amazonaws.com/phuse/public/PhUSE+Cloud+Doc+18-Nov-2016.docx (Word file for download) ]
 +
 +
The framework has reached it present state through the efforts of a core group plus the input of a great many participants since the work stream was established in 2013.  Thanks, in particular are extended to contributors from FDA.
 +
 +
In Nov 2015, the framework was presented to members of EMA's GCP Inspector Working Group and it is expected that follow-on dialog will take place. 
 +
 +
Further presentations on the framework, have, during 2016, been made to the Pistoia Alliance and the eClinical Forum as well as at the PHUSE Annual Conference in Barcelona and the DIA's Clinical Forum for Operational Excellence in Düsseldorf.
 +
<br>
  
 +
=Deliverables=
 +
* [https://www.phuse.eu/css-archive-deliverables Cloud Services: A framework for Adoption in the Regulated Life Sciences Industry (PDF) 18-Nov-16 Version 3.0]
 +
* [https://www.phuse.eu/white-papers Cloud Adoption - Framework Documents 24-Apr-19 Version 4.0]
  
Original file document [[Media:Lower_Barriers_to_the_Cloud_2013_06_14.doc|Lower Barriers to the Cloud]]
+
=Webinars=
 +
* [http://www.phuse.eu/documents//webinars/22-feb-16/anders-4564.pdf The PhUSE Framework for the Adoption of Cloud Technology in the Regulated Life Sciences Industry]  
 +
* [https://www.phusewiki.org/wiki/images/b/bf/PhUSE_WG_Cloud_Nov18_%282%29.pptx Cloud Services - A Framework for Adoption in the Regulated Life Sciences Industry 28/11/18]
  
 +
<br/>
  
 +
=Meeting Minutes=
 +
[[17th August 2017]] <br>
 +
[[31st August 2017]]<br>
 +
[[14th September 2017]]<br>
 +
[[28th September 2017]]<br>
 +
[[5th October 2017]]<br>
 +
[[19th October 2017]] <br>
 +
[[2nd November 2017]] <br>
 +
[[16th November 2017]] <br>
 +
[[14th December 2017]] <br>
 +
[[11th January 2018]] <br>
 +
[[17th January 2018]] <br>
 +
[[1st February 2018]] <br> 
 +
[[4th April 2018]] <br>
 +
[[2nd May 2018]] <br>
 +
[[30th May 2018]] <br>
 +
[[13th June 2018]] <br>
 +
[[8th August 2018]] <br>
 +
[[5th September 2018]] <br>
 +
[[3rd October 2018]]<br>
 +
[[12th December 2018]]<br>
 
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Last revision by {{REVISIONUSER}},{{REVISIONMONTH}}/{{REVISIONDAY}}/{{REVISIONYEAR}}
 
Last revision by {{REVISIONUSER}},{{REVISIONMONTH}}/{{REVISIONDAY}}/{{REVISIONYEAR}}
 
[[Category:Emerging Technology]]
 
[[Category:Emerging Technology]]
 
[[Category:ActiveProject]]
 
[[Category:ActiveProject]]

Latest revision as of 11:38, 1 July 2020

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 addressed.

Project Leads

Anders Vidstrup Project Lead NNIT avid@nnit.com
Lauren White Project Co-ordinator PHUSE lauren@phuse.eu

Project Team Members

Bob Streit Participant JNJ rstreit@its.jnj.com
Catherine Li Participant FDA Catherine.Li@fda.hhs.gov
Chris Whalley Participant Industry whalley@amazon.com
Dan Dziadiw Participant Merck Daniel.Dziadiw@merck.com
Evi Cohen Participant Appian Evi.Cohen@appian.com
Eunice Ndungu Participant Merck eunice_ndungu@merck.com
Hans Peter-Schreiter Participant Entimo hps@entimo.de
Lynn Caldwell Participant Pfizer Linda.J.Thibeault@pfizer.com
Martijn Van Beelen Participant GSK martijn.x.van-beelen@gsk.com
Andrew Matteson Participant Applied BioMath andrew.matteson@appliedbiomath.com
Pieter Stas Participant Business & Decision Life Sciences pieter.stas@businessdecision.com
Raechelle Raimondo Participant Allergan raechelle.raimondo@allergan.com
Richard Martinez Participant RHO World richard.martinez@rhoworld.com
Rocco Timpano Participant Pfizer Rocco.b.Timpano@pfizer.com
Sandy Estrada Participant Cervello, a Kearney Company sestrada@mycervello.com
Serena Peirson Participant Accenture serena.peirson@accenture.com
Stuart Ward Participant IDBS sward@idbs.com
Suzanne Studinger Participant Industry suzanne.studinger@qas.works
William Telford Participant Sanofi William.Telford@sanofi.com


The team has representatives from SaaS, PaaS and IaaS providers as well as "consumer organisations".

Further participation is always welcome - especially in the areas of:

  • Cloud technologies & IT infrastructure
  • Systems Validation & Quality Assurance
  • Regulations
  • Information Protection and IT Security
  • Legal
  • Procurement
  • R&D Applications Expertise
  • Training

Stakeholders

This workstream has generated value for serveral levels of stakeholder:

  • 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 the 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.

Project Status

The third edition of the framework document has recently been created and is currently awaiting publication. It is viewable at:

The framework has reached it present state through the efforts of a core group plus the input of a great many participants since the work stream was established in 2013. Thanks, in particular are extended to contributors from FDA.

In Nov 2015, the framework was presented to members of EMA's GCP Inspector Working Group and it is expected that follow-on dialog will take place.

Further presentations on the framework, have, during 2016, been made to the Pistoia Alliance and the eClinical Forum as well as at the PHUSE Annual Conference in Barcelona and the DIA's Clinical Forum for Operational Excellence in Düsseldorf.

Deliverables

Webinars


Meeting Minutes

17th August 2017
31st August 2017
14th September 2017
28th September 2017
5th October 2017
19th October 2017
2nd November 2017
16th November 2017
14th December 2017
11th January 2018
17th January 2018
1st February 2018
4th April 2018
2nd May 2018
30th May 2018
13th June 2018
8th August 2018
5th September 2018
3rd October 2018
12th December 2018


Last revision by Laurenwhite,07/1/2020