Waters Ships NuGenesis SDMS Vision Publisher
Milford, MA - For the GMP or production laboratory, the need to efficiently collect and make use of key scientific data to aid in the decision-making process has never been greater. Waters Corporation announced recently 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 high-quality 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 compliant-ready product that features status-based user access, configurable electronic signature hierarchies, full audit trials, and digital signatures. These features allow QC laboratory managers to follow the real-time status and compliance activities of the laboratory driven by SOP's and test methods.
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.
Predefined Application Packages
The 21 CFR Part 11 compliant-ready SDMS Vision Publisher includes a number of predefined ‘application packages' that utilize forms or templates to guide and enforce laboratory workflow. Entire routine laboratory experiments - such as studies for dissolution, content uniformity, or dynamic generation of test protocols – can be integrated into experimental write-ups automatically, reducing errors and tedious and time-consuming manual steps, maximizing efficiencies in the laboratory.
Application Package - Dissolution & Content Uniformity
Dissolution tests are often used in combination with content uniformity testing to ensure continuing product quality and performance after changes in the formulation, the process, site, or the scale-up of the manufacturing.
The Dissolution & Content Uniformity Application Package is a set of forms that support the various calculations for dissolution and content uniformity according to U.S. Pharmacopeia (USP) and the European Pharmacopoeia (Ph.Eur.).
Application Package - Serial Device Reader
The Serial Device Reader Application Package facilitates automated use with balances, pH-meters, or plate readers such as Tecan devices, all of which are commonly found in routine laboratories. The Vision Publisher form allows the scientist to select the instrument that data will be measured and optionally the target range of the measurement minimizing manual interaction while consistently guiding the routine aspect of the laboratory workflow.
This integrated logic of all the application packages predefined within Vision Publisher includes calculations, applies rules on user input, and manages the interoperability with other laboratory software systems. There are also Application Packages for Dynamic Test Generation for Biotechnology and Stoichiometry.
SDMS Vision Publisher allows the user to easily add selected content to documents by interactively or automatically extracting information from NuGenesis SDMS, Empower or MassLynx software, as well as other third party solutions, making it easy to adapt to the existing workflows in your lab. Once written, such experimental documents are available for use by other members of the laboratory or by colleagues in different geographic locations – now any individual connected to SDMS or provided with this accurate, published information has the ability to make more informed decisions, and make those decisions faster than ever before.
SOURCE: Waters Corporation