"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 (www.safe-biopharma.org)
SAFE-BioPharma Association is the non-profit association that created and manages the SAFE-BioPharma(R) 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 (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(R) is a trademark of SAFE-BioPharma Association. Any use of this trademark requires approval from SAFE-BioPharma Association.
SOURCE Waters Corporation