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Waters Corporation today announced that SDMS Vision Publisher™ (v.7.1 SR4), an electronic laboratory notebook solution for its NuGenesis® Scientific Data Management System (SDMS) has been certified compliant with the SAFE-BioPharma digital identity and signature standard.
“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. back to top » |
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