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- 应用平台：
Novatek International
- 语种：
英文
NOVATEK INTERNATIONAL PRODUCT SUITE
Nova-LIMS
Laboratory Information Management System
Nova-LIMS is powerful and scalable laboratory information management system that captures and
automates all laboratory information. Nova-LIMS is modular in design and built from a basic workload
management framework with instrument interface. With the capability of interfacing with the Novatek suite of
products, Nova-LIMS can expand to a full Quality Execution LIMS System with the addition of a dedicated
environmental monitoring solution, stability management, raw material and finished product analyzers.
Nova-LIMS creates a paperless integration of data by interfacing with equipment and incorporating statistical
packages.
Nova-CPM
Calibration & Preventive Maintenance Management Software
Novatek’s Calibration and Preventive Maintenance Management software, Nova-CPM, ensures that all
equip-ment and instrumentation within any organization are operating at specified performance levels.
Nova-CPM provides tools to track equipment and manage calibration and preventative maintenance
intervals. With built-in inventory management, Nova-CPM tracks your spare parts inventory allowing you
to set re-order points. Calibrations can be performed while in the system allowing you to enter
calibration data, perform calculations, monitor pass/fail results and create calibration certificates. Nova-CPM
is 21 CFR Part 11 compli-ant and can be utilized in both regulated and non-regulated industries. Nova-CPM
ensures the performance of an organization’s equipment and instrumentation before it impacts its product
quality
Novatek Environmental Monitoring
Environmental Monitoring Management Software
Novatek’s Environmental Monitoring Management is a proven industry standard system with over 20 years of
global use in the Pharmaceutical and Biotech industries. It is a risk and process-based system that provides
powerful tools that help proactively identify problems before they occur. Standard features include; real
time trending, visual pattern recognition, automated investigations and root-cause analysis help maintain
“state of control” in your process. As a true out–of-the-box solution Novatek Environmental Monitoring has
developed in response to years of user specifications and continuous improvement that meets the most
demanding requirements.
Nova-QMS
Quality Management System Software
Novatek’s Quality Management System, Nova-QMS, is a comprehensive solution designed to
address pharmaceutical & biotech companies’ most pressing quality issues including documentation,
corrective and preventive action procedures, production validation, metrics and traceability. Nova-QMS is a
process-driven application comprised of integrated modules such as document, audit, and training
management, CAPA, change control, incidents and deviations management, complaint management
and investigation. The modules can be purchased separately or all together and integrated. Nova-QMS
enables organizations to increase efficiencies and achieve compliance by integrating related events
and actions, streamlining workflow, and facilitating trending and reporting across all quality systems.
Nova-Stability
Stability Management Software
Nova-Stability enables users to easily initiate and manage stability studies from the time the sample is
placed into the program until the calculation of its shelf-life and beyond. Nova-Stability has a fully integrated
statistical package that helps calculate shelf life in minutes providing a significant savings in time and labor.
Its design takes into consideration the latest guidelines from the FDA, TPP, ICH and EU, among others,
pertaining to pharmaceutical, chemical, biological and biotechnological fields. Nova-Stability Management
Software is designed for all types of products, in any stage of its lifecycle, from pre-clinical to clinical, to
manufacturing and post market.
Nova-Cleaning Validation
Automated Risk-Based Contamination Control
The Nova-Cleaning Validation Software is the industry standard for automation of your cleaning validation
process. Nova-Cleaning Validation significantly enhances product integrity by managing changes in the
manufacturing process, equipment, product composition etc. and assessing the risks associated with cross
contamination. With computerized risk-based worst case determination and fully automated MAC calcula-tions
the system is able to accurately execute hundreds of calculations in seconds instead of hours. This reduces
errors while improving efficiency that saves time and money. Nova-Cleaning Validation complies with 21 CFR
Part 11 and EU Annex 11. The system uses a risk-based approach and was designed based on PDA Technical
Reports 29, 49, ISPE MaPP and 21 CFR Part 211.67.
Automated Proofreading Software
Novatek’s Automated Proof Reading software works through a comparison method. All incoming
printed materials are compared against a pre-approved master document for any discrepancies in the text,
graphics, and color. Novatek’s Automated Proof Reading software is capable of proofreading virtually any
type of file from multilingual text documents, labels, images, graphics and even Braille content in seconds.
Known for its precision, simplicity, and speed, Novatek’s Automated Proof Reading software has proven
vital in reducing errors, maximizing productivity and increasing the accuracy of the proof reading process.
Column Organizer Software
Novatek’s Column Organizer Software, designed by experts in chromatography, has complete column
inven-tory management that provides users with detailed information on column ID, name, type,
manufacturer, supplier, location, and status. Radio Frequency Identification (RFID) technology can
also be used to automate the process even further, providing a fully compliant and paperless
environment. Offered with a HPLC/GC column cabinet, the column organizer software system is the
ideal integrated software/cabinet solution that facilitates easy and efficient column management.
Consumable Inventory Management Software
Novatek’s Consumable Inventory Management Software is a powerful inventory management
software system that accurately tracks samples, reference standards, controlled substances and narcotics,
reagents, materials, compounds, specimens and other items used throughout various laboratories and
organizations. A chain of custody is maintained for the materials from the point of receipt, throughout
its life cycle and beyond. Internal/external orders and bill of materials are created directly in the system
for easy and quick transfer of items from one location to another via serialization and bar-coding. This
inventory management system allows users to quickly access vital information such as the physical
location, amount, history or shipments of any lot or item in question.
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文献和实验相关实验
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