Waters SDMS Vision Publisher Now Certified Compliant with SAFE-BioPharma Digital Standard
15 Diciembre 2009 - 9:00AM
PR Newswire (US)
Vision Publisher Optimizes Workflow and Reduces Compliance Risk
with Efficient Data Management MILFORD, Mass., Dec. 15
/PRNewswire-FirstCall/ -- Waters Corporation (NYSE:WAT) today
announced that SDMS Vision Publisher(TM) (v.7.1 SR4), an electronic
laboratory notebook solution for its NuGenesis® Scientific Data
Management System (SDMS), a secure electronic repository that
stores and manages all types of scientific data to a centralized
database and is used to boost efficiency in life sciences
laboratories, has been certified compliant with the SAFE-BioPharma
digital identity and signature standard. The SAFE-BioPharma
standard is broadly used within the pharmaceutical industry to
apply signatures to forms, contracts and other documents and to
manage digital identities. "We sought compliance for SDMS Vision
Publisher to make it consistent with the way many life sciences
laboratories sign their documents - namely by using SAFE-BioPharma
digital signatures. We view SAFE-BioPharma compliance as an
additional value that gives us a competitive edge in the life
sciences laboratory marketplace," said Thomas Schmidt, Vision
Publisher Senior Product Manager. When used in laboratory settings,
SAFE-BioPharma digital signatures provide greater protection of
intellectual property than conventional electronic or traditional
wet signatures. They also simplify the process of document
archiving and retrieval. SAFE-BioPharma digital signatures are
legally-enforceable and comply with global regulatory requirements.
Additionally, SAFE-BioPharma digital signatures create a permanent
record of the date and time the signature was applied. They are
valid for the life of the document; any change to the document
invalidates the signature and alerts the viewer. "By certifying
compliance with the SAFE-BioPharma standard, Waters is positioning
SDMS Vision Publisher to meet the digital signature requirements of
the life sciences sector as it transitions to fully electronic
signatures and business processes," said Mollie Shields-Uehling,
president and CEO, SAFE-BioPharma Association. SDMS Vision
Publisher is an electronic laboratory notebook for use in
analytical laboratories that optimizes the utilization of
information collected and cataloged by SDMS. It supports existing
workflows and eliminates the time and effort spent with paper-based
data. It provides a secure, compliant-ready repository for
scientific data files and improves the value of information by
enabling scientists to unify, share, and fully reutilize scientific
data generated from the vast array of laboratory applications.
Laboratory information managed by SDMS Vision Publisher includes
spreadsheets and tables; text, authored reports, and comments;
images and drawings; chemical structures; and spectra and
chromatograms. The product is fully 21 CFR Part 11 compliant-ready
and, among other features, provides role and status-based user
access, a full system of audit trails, and protection of
intellectual property from the moment of its creation or change.
About SAFE-BioPharma Association (http://www.safe-biopharma.org/)
SAFE-BioPharma Association is the non-profit association that
created and manages the SAFE-BioPharma® digital identity and
signature standard for the pharmaceutical and healthcare
industries. The SAFE-BioPharma industry standard is used to
mitigate legal, regulatory and other business risk associated with
business-to-business and business-to-regulator electronic
transactions. It facilitates interoperability by providing a
secure, enforceable, and regulatory-compliant way to verify
identities of parties involved in electronic transactions. Because
the standard is linked to the Federal Bridge PKI Architecture
through the 4BF (http://www.the4bf.com/), a SAFE-BioPharma digital
identity can be trusted by any Federal agency. SAFE-BioPharma's
vision is to be a catalyst in transforming the biopharmaceutical
and healthcare communities to a fully electronic business
environment by 2012. The Association's members include: -- Abbott
-- Amarin Corp. -- Amgen -- AstraZeneca -- Bristol-Myers Squibb --
GlaxoSmithKline -- Johnson & Johnson -- Eli Lilly -- McDougall
Scientific -- Merck -- National Notary Association -- Novartis --
Oxford Outcomes -- Pfizer -- Premier Inc. -- Roche --
Sanofi-Aventis -- ScheringPlough-Organon -- SNAP Diagnostics --
Waters Corporation About Waters Corporation
(http://www.waters.com/) Waters Corporation creates business
advantages for laboratory-dependent organizations by delivering
practical and sustainable innovation to enable significant
advancements in such areas as healthcare delivery, environmental
management, food safety and water quality worldwide. Pioneering a
connected portfolio of separations science, laboratory information
management, mass spectrometry and thermal analysis, Waters
technology breakthroughs and laboratory solutions provide an
enduring platform for customer success. With revenue of $1.58
billion in 2008 and 5,000 employees, Waters is driving scientific
discovery and operational excellence for customers worldwide.
Waters, SDMS Vision Publisher, and NuGenesis are trademarks of
Waters Corporation. SAFE-BioPharma® is a trademark of
SAFE-BioPharma Association. Any use of this trademark requires
approval from SAFE-BioPharma Association. DATASOURCE: Waters
Corporation CONTACT: Brian J. Murphy, Waters Corporation,
+1-508-482-2614, ; Jon Weisberg, SAFE-BioPharma Association,
+1-801-359-9977, Web Site: http://www.waters.com/
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