Waters has released the SDMS Vision Publisher for its NuGenesis Scientific Data Management System, a secure electronic repository that stores and manages all types of scientific data to a centralised database.
The Vision Publisher allows laboratories to electronically capture primary data from a variety of laboratory devices and instruments and attach that information (and associated metadata) to the experimental record for any investigational or manufactured product, be it a promising drug candidate or a newly manufactured lot of product awaiting release.
The software prevents transcription errors, streamlines review and approval processes, accelerates record retrieval, and facilitates audits. It helps scientists to comply to 21 CFR Part 11 regulations with predefined application packages that include forms and templates to guide the lab’s workflow.
SMDS Vision Publisher uses secure, software-generated, time-stamped audit trails to independently record the date and time of operator entries as well as actions that create, modify, or delete electronic records.
The software features status-based user access, configurable electronic signature hierarchies, full audit trials, and digital signatures. These allow QC laboratory managers to follow the real-time status and compliance activities of the laboratory driven by SOP’s and test methods.