Dear Friends,
Happy New Year! In this quick edition of the LSIT Minute I would simply like to point out that we've made some updates to the GIP table of contents.
We've been listening to our volunteers (more than 60 people now, reaching India, England, Sweden and Australia) who have made great suggestions as
they pull back the curtains of scope and topics that we are developing for the Good Informatics Practices (GIP) Guidance Document.
In our table of contents we have added chapters 16 and 17.
Uncovering the benefits and ROI for IT is becoming much more important. To this end, we've started chapter 16, IT Strategies,
where we will be addressing the business decisions of adopting (or not adopting) leading edge technologies. As with other chapters, we are taking a risk-based approach to the topic,
and will be incorporating how to evaluate technologies and how they align with the organization’s strategy and overall intent of the project.
Our hope is to add further thought processes and education to decrease the number of IT project failures.
Chapter 17 is a comprehensive GIP Glossary. Who knew there could be 2-3 definitions for the same word depending on how it’s used in engineering,
devices vs. pharmaceuticals or information management!
And, as always, we invite you to get involved. On behalf of the entire, LSIT team, best wishes to you all for the upcoming year.
- Anette
Briefly:
- Risk Management Approach to IT Quality
- NGP Interview with LSIT Chairman Geoff Odell
- Kudos to Janet Vorhariwatt
- Life Sciences Career Opportunities
by Barbara Nollau, Executive Consultant for
Global Life Sciences, Inc.
Risk-based approaches to compliance are today’s norm (or at least they should be.) From the perspectives of regulators, as well as from a business sense perspective,
applying the same rigorous model to everything in a regulated context doesn’t make sense. Quality and compliance are not black and white issues, and an objective method
for determining risk and translating that knowledge into the appropriate level and rigor of controls brings definition to how to handle the many shades of grey.
Read the full article here.
Next Generation Pharmaceuticals caught up with
Geoff Odell, Chairman of the LSIT Global Institute to discover how instrumental IT is to the life science drug pipeline. Geoff talks about the
unique challenges that IT faces in the industry, the benefits and bottlenecks of technology, and the role LSIT in leveling the playing field for everyone.
Check out the article at NGP's website
Janet Vorhariwatt, a volunteer in the Infrastuructre Working Group is on of our dynamo Project Managers. She is
CEO of iChannex and has carried key leadership roles in major corporations like SAIC
and Xerox. Janet has brought inspiration and drive to 12 volunteers who have truly embraced this working group as a team. The amazing thing about building these
working groups is that like attracts like. Janet has recruited volunteers who are superstars and experts that have run everything from security and surveillance at the White House,
to running entire companies.
We are delighted and grateful for the energy and mindshare that has developed within the Infrastrucutre Working Group. Thank you Janet,
your work and dedication are amazing.
Our friends at DavenportMajor Executive Search are currently seeking an Associate Director of Regulatory Affairs for
the New Ventures business in Santa Clara, CA
and a Regulatory Affairs Manager of Core Products, located just outside of San Diego in Temecula, CA with approximately 3-5 yrs of industry experience. If you are interested in applying,
please contact them at 858-847-0700 or on the web at www.davenportmajor.com.
If you have a Life Sciences position that you would like considered for the LSIT Minute, feel free to send me an e-mail at Anette@LSIT.org.
LSIT Calendar
03.06.07
BIOCOM's 2007 CALBIO Conference
03.19 - 03.22.07
GAMP Americas Forum, San Francisco, CA
03.27 - 03.29.07
IVT Presents: Quality Systems
05.02 - 05.04.07
ITCi: IT Compliance Conference
05.06 - 05.09.07
BIO 2007 International Convention
06.17 - 06.21.07
43rd Annual DIA Meeting
Members & Affiliates
Pfizer, Inc.
Novartis
Sun Microsystems
Amylin Pharmaceuticals
eKM Corporation
Frost & Sullivan
Mission3, Inc.
California State University
Integra International
WunderMarx, Inc.
RCM Technologies, Inc.
BIOCOM
S.D. World Trade Center
S.B.S.
IEEE
GAMP
CDISC
Heller Ehrman
NanoBioNexus
Burnham Institute
Prosanos Corporation
UCSD Global Connect
UCSD School of Medicine
W3C
LINC
What is GIP?
The vehicle by which LSIT will imbue trust in the bioresearch enterprise will be the application of trusted IT guidelines through
Good Informatics Practices (GIP). Read about how LSIT intends to develop GIP here
Contact Us
By all means, feel free to call us if you have questions, comments or ideas. We live to the rule of being open and accessible,
and listen to our members and colleagues.
LSIT Global Institute
7825 Highland Village Place
Suite 505
San Diego, CA 92129
(858)759-4750
E-Mail: Anette@LSIT.org
Website: www.lsit.org
And finally...
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