FDA Compliant Systems in the Cloud: Five Requirements You Must Satisfy!

Life Sciences, Pharmaceutical, Pharmaceutical Regulation,
  • Thursday, May 07, 2015

Life Sciences companies, like all enterprises, continue to move towards a cloud first strategy when making IT application investments. The increased access, flexibility and improved collaboration of a cloud platform can mean the difference of months for a new therapy being brought to market. When it comes to moving regulatory solutions to the Cloud, additional concerns around 21 CFR Part 11 Compliance emerge.

This webinar will deliver key considerations and imperative questions you must ask of any cloud services provider to ensure the offering can satisfy key requirements of 21 CFR Part 11. In addition, we will be covering essential questions to ask during the vendor audit of a cloud provider.

Featured Topics:

  • Market and technology trends driving cloud adoption of Life Science’s regulated applications.
  • Five key requirements your cloud solution must support to ensure compliance with FDA 21 CFR Part 11.
  • Potential pitfalls of not addressing each requirement.
  • New vendor audit questions you must ask of your cloud provider and why.
  • A review of applicable security and compliance requirements.
  • Reviewing successful validation techniques already in use.

Learning Objectives:

At the conclusion of this webinar, participants should be able to:

  • Understand key requirements for cloud-based solutions to satisfy FDA 21 CFR Part 11.
  • Learn how to mitigate trust, security and compliance risks.
  • Know the questions to ask during the cloud provider evaluation process.
  • Understand the importance of regulatory approval and certification for data protection by FDA, EMA and other health agencies.
  • Better evaluate the IT implications and investments needed for adoption of a cloud-based solution.


Matt Walz, B.S., M.B.A., Chief Strategy Officer, NextDocs Corporation

Matt Walz, co-founder of NextDocs, is responsible for driving NextDocs technology vision and executing strategic initiatives for the company. Mr. Walz manages all aspects of the product development lifecycle, including product management, engineering, test, release, and documentation.

Prior to NextDocs, Mr. Walz served as Director of Software and Services for DataLabs where he led product development, consulting services and customer support for the company’s collaborative solutions business. Mr. Walz also held several technical and managerial positions for Microsoft Corporation, Morgan Lewis and Bockius, PSCI and the Rollins Corporation.

Mr. Walz has delivered keynote addresses and been a featured speaker on the impact of technology on compliance and regulated industries at events such as Drug Information Association (DIA), Boston Society’s Applied Pharmaceutical Software, Microsoft’s Life Science Innovation Forum, ShareFEST and GR8 Philadelphia. In 2013 Mr. Walz was named one of Philadelphia’s 40 Under 40 by the Philadelphia Business Journal. In 2011 he was awarded SmartCTO by Philadelphia’s SmartCEO Magazine.

Mr. Walz holds an M.B.A. from the University of Delaware’s Learner College of Business and Economics and a Bachelor’s of Science in Computer Science from the University of Delaware.

Message Presenter

Who Should Attend?

Senior level professionals working in the following areas:

  • Clinical Trials
  • Clinical Development
  • Clinical Operations
  • Quality Assurance
  • Regulatory Affairs
  • IT
  • Document/Records Management

Xtalks Partner


NextDocs is a global leader in compliance innovation enabling businesses in regulated industries to achieve compliance with FDA, EMA and other agencies while innovating processes, increasing efficiency and dramatically reducing costs. NextDocs provides solutions for managing regulatory documents, SOPs and clinical documents as well as a full set of quality processes from CAPA to complaints. Our customers include Pharmaceutical companies, biotech firms, device manufacturers and contract research organizations.

With over 100 employees and offices in the US, EU and Japan, NextDocs automates compliance and business processes for five of the ten largest Pharmaceutical companies in the world and over 100 other leading life sciences companies. For more information visit us at NextDocs.com.

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