Helping QC Laboratories Optimize Workflow and Reduce Compliance Risk with Efficient Data Management

For the GMP or production laboratory, the need to efficiently collect and make use of key scientific data to aid in the decisionmaking process has never been greater. Waters Corporation (USA) announce it is shipping SDMS Vision Publisher 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. With Waters® Vision Publisher, laboratories choosing Waters NuGenesis SDMS for their scientific data management needs, can electronically capture primary data from a variety of laboratory devices and instruments and append 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. With SDMS Vision Publisher, key experimental data becomes part of the permanent electronic record preventing transcription errors, streamlining review and approval processes, accelerating record retrieval, and facilitating audits.

With SDMS Vision Publisher, scientists can: Increase the utility of information collected by NuGenesis SDMS; Make decisions faster in an operationally consistent and efficient environment; Help satisfy compliance requirements; Document the discoveries of scientists electronically; Mine and access highquality scientific information from NuGenesis SDMS; Easily compare and contrast results from different analytical techniques and vendors; Tightly control experimental results to ensure intellectual property traceability. Comprehensive Audit Trail Information. SDMS Vision Publisher is a compliantready product that features statusbased user access, configurable electronic signature hierarchies, full audit trials, and digital signatures. These features allow QC laboratory managers to follow the realtime status and compliance activities of the laboratory driven by SOPâ„¢s and test methods. SMDS Vision Publisher uses secure, softwaregenerated, timestamped audit trails to independently record the date and time of operator entries as well as actions that create, modify, or delete electronic records.