Resource Center: Project Management

Information Technology Project Management Resources


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General Project Management Resources

Below are links to a number of web resources for project management, pharmaceutical and biotech information, and technology information useful to IT project managers in the life sciences industry.

Gantthead.com
Provides processes, templates, articles and discussions to aid in managing information technology projects.
http://www.gantthead.com/

Construx
Construx's Steve McConnell is a well-known pragmatic author and software process improvement advocate. Construx offers training, advice, and numerous software engineering resources.
http://www.construx.com/

Software Productivity Center
Provides a number of project management software development process improvement resources and self assessment tools.
http://www.spc.ca

Projects@Work
Provides processes, tool reviews, articles, discussions and other research for project management and software development professionals.
http://www.projectsatwork.com

PMForum
Includes research, news, discussions and best practices for project managers.
http://www.pmforum.org/

Pharmaceutical Institute
The Pharmaceutical Institute offers books and educational materials for the pharmaceutical and biotech industry professionals; useful for project managers looking to augment their domain knowledge.
http://www.pharmainstitute.com/

Process Impact
Focuses on software process improvement with an emphasis on the requirements phase of the software development life cycle. This site includes books, templates, white papers, and training materials.
http://www.processimpact.com/

QA Edge
Has compiled an excellent software development book list, which includes books specific to validation and SOP authoring for regulated pharmaceutical applications.
http://www.qaedge.com/books.html


AllPM
Provides various project management resources including templates, links and articles.
http://www.allpm.com/


Templates and Methodologies
Below is a selection of web sites that provide project methodologies and templates in a wide price range  some are free.


VECS is looking for one or more web sites that provide templates specific to computer system validation (e.g., Validation Plan and Report, Installation/Operational Qualification, SOPs). If you know of a resource please
e-mail us at info@vecs.com.
Featured Article
Former and current clients discuss the state of the art and the future of EDC.

It's Standards Time - Pharma does EDC in clinical trials, but is anyone doing it right?

"Technology is primarily what's driving improved operational efficiency in clinical development today, ... And EDC is probably the one technology that more companies are embracing for the first time than any other tool."


Project Management News

Validation News

    News More news

Quick Reference
The sites below provide definition for pharmaceutical, technology, and project management terms and phrases.

• Hyperdictionary Medical Dictionary

• Medical Dictionary Search Engine

• Webopedia

• Wikipedia

• Project Management Basics™ Glossary

• Computer Validation Glossary

• CDISC Clinical Research Glossary, Version 5.0

• Acronyms, Abbreviations, and Initials, Version 5.0




Pharmaceutical Industry and Project Management Associations

Project Management Institute
"PMI stands as a global leader in the development of standards for the practice of project management. Our premiere standards document, A Guide to the Project Management Body of Knowledge (PMBOK® Guide), is recognized throughout the world as a standard for managing projects in today's marketplace." "PMI's Project Management Professional (PMP®) certification is the preeminent professional credential for individuals associated with project management." The site includes a variety of project management resources, papers, and publications.
http://www.pmi.org

PMI Pharmaceutical Special Interest Group
"We provide a unique opportunity for project management professionals in the pharmaceutical, bio-tech, contract research, and medical device industries to network with and learn from one another."
http://www.pharmasig.org/

PMI Delaware Valley Chapter
The Delaware Valley Chapter of the PMI serves the Greater Philadelphia Area, South Jersey, Delaware and Northern Maryland.
http://www.pmi-dvc.org

DIA (Drug Information Association)
"DIA is a professional association of approximately 20,000 members worldwide who are involved in the discovery, development, regulation, surveillance, or marketing of pharmaceuticals or related products." DIA offers a number of seminars, webinars, training, and networking opportunities.
http://www.diahome.org/

Society for Clinical Data Management
"The Society for Clinical Data Management (SCDM) is a non-profit professional society founded to advance the discipline of Clinical Data Management."
http://www.scdm.org

Association for Clinical Research Professionals
"ACRP is the primary resource for clinical research professionals in the pharmaceutical, biotechnology, and medical device industries, as well as those in hospital, academic medical centers, and physician office settings."
http://www.acrpnet.org/

Institute for Validation Technology
"As publisher of the Journal of Validation Technology® and the Journal of GXP Compliance®, we are dedicated to expanding the global knowledge base for validation and compliance professionals in FDA-regulated industries."
http://www.ivthome.com




Project Management, Requirements Management, and Quality Assurance Tools
Below are a few sites that link to extensive lists of project management and software engineering tools.

ProjectReference
Comprehensive set of project management tools, references and examples.
http://www.projectreference.com/

Applied Testing and Technology
Extensive set of testing and quality assurance tools, templates and information resources.
http://www.aptest.com/resources.html

INCOSE Requirements Management Tools Survey
Survey covering over 30 requirements management tools.
http://www.paper-review.com/tools/rms/read.php

Requirements Engineering Tools
This site provides a comprehensive list of requirements engineering tools.
http://easyweb.easynet.co.uk/~iany/other/vendors.htm

Featured Tools
The sites below offer free web-based wiki (i.e. web pages editable by a group) applications:

• JotSpot

• Wiki

• Socialtext



The sites below offer free web-based office and document applications:

• Writely

• ajaxWrite

• thinkfree



Featured articles on Web 2.0 tools:

Web 2.0 Revolution: Power to the People Key Web 2.0 sites




Other Tools Used by VECS
Below are other tools that VECS has successfully used.

Collaboration

Yahoo! Groups
Free, easy to use collaboration tool.
http://groups.yahoo.com/

Webex WebOffice
Online intranet and repository for documents, schedules, and other information.
http://www.weboffice.com

eRoom
Online intranet and repository for documents, schedules, and other information.
http://software.emc.com/microsites/eRoom/index.jsp


Planning

eProject
Online project planning software.
http://www.eproject.com/


Timekeeping

NetSuite
Online bookkeeping and time tracking.
http://www.netsuite.com/

Quickbooks Online Edition
Internet-based accounting software and time tracking.
http://oe.quickbooks.com/


Estimating

Construx Estimate
Easy to use software project estimation tool.
http://www.construx.com/products/estimate.php


Resource Evaluation

Brainbench
Provides products for assessing employee skills pre and post hire.
http://www.brainbench.com/

Popular Searches

• software engineering project management methodology

• project management tools applications

• project management certification

• project management resources

• pharmaceutical project management associations

• software development estimating



Technology News

More Technology
news from InformationWeek.



Articles, Presentations, and Webcasts

Articles
Below are a few recently archived articles that discuss current trends in project management.

Periodicals
Following are some periodicals which focus on project management, the pharmaceutical industry, and information technology.

  • Applied Clinical Trials - The Global Guide to Clinical Trials Management
  • BioPharm International - The Applied Technologies of Biopharmaceutical Development·     
  • Pharmaceutical Executive - A Global Business and Marketing Publication
  • Pharmaceutical Technology

Webinars
PMI Pharmaceutical Special Interest Group regularly offers project management webinars - Click on Webinars. PharmaSIG membership is required.

Upcoming IT Management and Health and Life Sciences webinars from BetterManagement.com






Conferences
Below is a list of recurring project management conferences:






FDA Guidance
Following is a small subset of frequently referenced FDA guidance.

General Principles of Software Validation - January, 2002
This document provides guidance for development of validated software (i.e. software that is fit for its intended use).
http://www.fda.gov/cdrh/comp/guidance/938.pdf

Computerized Systems Used in Clinical Trials - April, 1999
This document provides guidance for development...
http://www.fda.gov/ora/compliance_ref/bimo/ffinalcct.pdf

Draft Guidance - Computerized Systems Used in Clinical Trials - September, 2004
This document provides guidance for development...
http://www.fda.gov/cder/guidance/6032dft.pdf

Electronic Records and Electronic Signatures (21 CFR Part 11)
The following describe the FDA’s rule for implementing electronic records and electronic signatures and provide guidance for applying the rule known as 21 CFR Part 11.
http://www.fda.gov/ora/compliance_ref/part11/

Glossary of Computerized System and Software Development Terminology
This document is referenced in many of the FDA’s guidance documents.
http://www.fda.gov/ora/inspect_ref/igs/gloss.html

A list of all the FDA’s current guidance documents is available here.
http://www.fda.gov/cder/guidance/ 



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