GAMP® Good Practice Guides Under Development

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A Risk-Based Approach to Regulated Mobile Applications

This new Guide is in Draft 1 development.

Mobile applications (apps) are becoming more and more common. This proliferation includes new apps that stray into areas regulated by health authorities such as the FDA. There are several challenges involved in managing the risks associated with what is effectively a new class of software in the regulated arena.

This Good Practice Guide is intended to provide a risk-based approach to managing the development and support of regulated mobile applications.

As far as possible this will be interpretation of how the principles and key concepts of GAMP 5 can be applied to this type of product and technical area.

If you would like to submit a proposal for a Guidance document, please go to ISPE's Electronic Proposal Submissions.

For more information, contact ISPE at Ask@ispe.org

ISPE Technical Document Draft KEY

Proposal: First stage of the Document Development Process which provides the Guidance Documents Committee (GDC) with sufficient information to determine if the proposed topic justifies an industry need to create a guidance document.

Document Plan: Second stage of the Document Development Process which contains a proposed Purpose and Objectives, Scope and Key Concepts, Structure (may include Outline), Team Organization with Core Team identified, Stakeholders, and Project Planning.

Outline: Made available online for the benefit of ISPE members to view the direction that a Task Team is taking in regard to a topic area. This also allows Members to indicate their willingness to participate in the development of a Guidance Document (where appropriate).

Executive Summary: Drafts of the introductory chapter(s), the regulatory chapter(s), descriptive outlines of other chapters, and titles of proposed appendices; developed to facilitate discussion of regulatory issues between task teams and regulatory agencies, as well as, to further illustrate the direction of the guidance document to Members.

Draft 1: First draft which includes main body of the document and drafts of all chapters and appendices (circa 80% to 90% complete). This draft is issued for industry review giving Members the opportunity to provide comment.

Draft 2: Final draft which includes all industry comments incorporated, as appropriate, and final technical edits completed. Proceeds to GDEC for review/approval, then fed into the ISPE Publication Process. If a Baseline® Guide, this draft is issued to the FDA for technical review prior to ISPE Publication Process.

Last Update: 03 March 2014

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