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share your experience and expertise by responding to inquiries.
Note that only ISPE Members can engage in these activities. If you are not an ISPE Member, join ISPE and take advantage of all the benefits that membership has to offer.
GAMP UK Event 25th April 2013 - Presentations for Download
- ROI of Test Automation Calculator ( 71 KB)
This spreadsheet is complementing the article "The Return on Investment (ROI) of Test
Automation" published in Pharmaceutical Engineering, July/August 2012, 32(4).
- GAMP COP Annex 11 Interpretation Final V2 ( 176 KB)
This interpretation of the revised Annex 11 requirements has been produced by a core GAMP COP Task Team, and
reviewed by the GAMP COP Council and members of GAMP Regional Steering Committees. The revised Annex 11
adopts a risk based approach, and is aligned with current industry good practice.
- Alternative Software Development Models and Methods ( 619 KB)
New software development tools and methods are being introduced by software suppliers in order to increase
the amount of iteration and interactivity in the development process. As a result, the healthcare and life
science industries are increasingly being confronted with these new methods. The GAMP D-A-CH (Germany,
Austria and Switzerland) Special Interest Group “Alternative Software Development Models and Methods” (ASDMM)
convened to investigate how these new tools and methods could be used in the development of validated
- Ensuring Data Entry in a Regulated Environment
This article explores the steps necessary to ensure the integrity of data generated and maintained by
chromatography data systems (CDS) in a regulated GXP environment. It has been driven partly by recent content
of some U.S. Food and Drug Administration (FDA) warning letters and the publication of the new European Union
(EU) GMP Annex 11 regulations.
- GAMP Americas Special Interest Group Summaries ( 652 KB)
- Compliance in the Clouds ( 6 MB)
A discussion of cloud computing, the impact and risks of outsourcing infrastructure, data storage,
applications and/or other IT services to third party suppliers while maintaining a secure and compliant
- IT Outsourcing and Offshoring: Recognizing the Risks ( 1 MB)
GAMP Americas 2009 Forum presentations: An overview and outline of problems and practical approaches in our
evolving global environment, and resulting business, legal and compliance impact.
- Bristol Myers Squibb, Devens Massachusetts Paperless
Plant ( 1 MB)
Presentation overview and outline for practical implementation of the ASTM-E2500 standard. Precursor to the
forum workshop on ASTM 2500-07
- Change Is In the Air ( 248 KB)
Welcome, introduction and short risk topic poll presentation for the GAMP Forum held at Gillette Stadium near
Boston Massachusetts in conjunction with the ISPE Boston chapter Product Show.
- GAMP in a Nutshell ( 4 MB)
This presentation was delivered at the ISPE NJ Chapter meeting in Bridgewater, NJ on February 10, 2009. It
was followed by a panel discussion led by Randy Perez, Winnie Cappucci, and Paul D'Eramo.
- Electronic Source Documentation in Clinical
Investigations ( 166 KB)
This document provides guidance to sponsors, contract research organizations (CROs), data management centers,
and clinical investigators on capturing, using, and archiving electronic data in FDA-regulated clinical
- Clinical Electronic Records Reflection Paper ( 127 KB)
European Medicines Agency reflection paper on expectations for electronic source data and data transcribed to
electronic data collection tools in clinical trials.
Indicates content available to ISPE members only.