Cloud Adoption in the Life Sciences Industry

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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 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
James McDermott Participant Industry mc_dermotts@me.com
Lawrence Sleeper Participant Industry Lawrence.sleeper@gmail.com
Linda Thibeault Participant Pfizer linda.j.thibeault@pfizer.com
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
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,10/29/2019

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