Waters' SDMS Vision Publisher, an electronic laboratory notebook solution for its Nugenesis Scientific Data Management System has been certified compliant with the Safe-Biopharma standard.
Nugenesis is a secure electronic repository that stores and manages all types of scientific data to a centralised database and is used to boost efficiency in life-sciences laboratories.
The Safe-Biopharma standard is used within the pharmaceutical industry to apply signatures to forms, contracts and other documents, and to manage digital identities.
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.
They also 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.
SDMS Vision Publisher is an electronic laboratory notebook for use in analytical laboratories that optimises the utilisation of information collected and catalogued by SDMS.
It supports existing workflows and eliminates the time spent on 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 reutilise scientific data generated from 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 and 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.