Novatek International（制药行业合规软件

NOVATEK INTERNATIONAL PRODUCT SUITE  Nova-LIMSLaboratory Information Management SystemNova-LIMS is powerful and scalable laboratory information management system that captures andautomates all laboratory information. Nova-LIMS is modular in design and built from a basic workloadmanagement framework with instrument interface. With the capability of interfacing with the Novatek suite ofproducts, Nova-LIMS can expand to a full Quality Execution LIMS System with the addition of a dedicatedenvironmental monitoring solution, stability management, raw material and finished product analyzers.Nova-LIMS creates a paperless integration of data by interfacing with equipment and incorporating statisticalpackages.  Nova-CPMCalibration & Preventive Maintenance Management SoftwareNovatek’s Calibration and Preventive Maintenance Management software, Nova-CPM, ensures that allequip-ment and instrumentation within any organization are operating at specified performance levels.Nova-CPM provides tools to track equipment and manage calibration and preventative maintenanceintervals. With built-in inventory management, Nova-CPM tracks your spare parts inventory allowing youto set re-order points. Calibrations can be performed while in the system allowing you to entercalibration data, perform calculations, monitor pass/fail results and create calibration certificates. Nova-CPMis 21 CFR Part 11 compli-ant and can be utilized in both regulated and non-regulated industries. Nova-CPMensures the performance of an organization’s equipment and instrumentation before it impacts its productquality  Novatek Environmental MonitoringEnvironmental Monitoring Management SoftwareNovatek’s Environmental Monitoring Management is a proven industry standard system with over 20 years ofglobal use in the Pharmaceutical and Biotech industries. It is a risk and process-based system that providespowerful tools that help proactively identify problems before they occur. Standard features include; realtime 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 hasdeveloped in response to years of user specifications and continuous improvement that meets the mostdemanding requirements.  Nova-QMSQuality Management System Software Novatek’s Quality Management System, Nova-QMS, is a comprehensive solution designed toaddress pharmaceutical & biotech companies’ most pressing quality issues including documentation,corrective and preventive action procedures, production validation, metrics and traceability. Nova-QMS is aprocess-driven application comprised of integrated modules such as document, audit, and trainingmanagement, CAPA, change control, incidents and deviations management, complaint managementand investigation. The modules can be purchased separately or all together and integrated. Nova-QMSenables organizations to increase efficiencies and achieve compliance by integrating related eventsand actions, streamlining workflow, and facilitating trending and reporting across all quality systems.  Nova-StabilityStability Management SoftwareNova-Stability enables users to easily initiate and manage stability studies from the time the sample isplaced into the program until the calculation of its shelf-life and beyond. Nova-Stability has a fully integratedstatistical 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 ManagementSoftware is designed for all types of products, in any stage of its lifecycle, from pre-clinical to clinical, tomanufacturing and post market.  Nova-Cleaning ValidationAutomated Risk-Based Contamination ControlThe Nova-Cleaning Validation Software is the industry standard for automation of your cleaning validationprocess. Nova-Cleaning Validation significantly enhances product integrity by managing changes in themanufacturing process, equipment, product composition etc. and assessing the risks associated with crosscontamination. With computerized risk-based worst case determination and fully automated MAC calcula-tionsthe system is able to accurately execute hundreds of calculations in seconds instead of hours. This reduceserrors while improving efficiency that saves time and money. Nova-Cleaning Validation complies with 21 CFRPart 11 and EU Annex 11. The system uses a risk-based approach and was designed based on PDA TechnicalReports 29, 49, ISPE MaPP and 21 CFR Part 211.67.  Automated Proofreading SoftwareNovatek’s Automated Proof Reading software works through a comparison method. All incomingprinted 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 anytype 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 provenvital in reducing errors, maximizing productivity and increasing the accuracy of the proof reading process.  Column Organizer SoftwareNovatek’s Column Organizer Software, designed by experts in chromatography, has complete columninven-tory management that provides users with detailed information on column ID, name, type,manufacturer, supplier, location, and status. Radio Frequency Identification (RFID) technology canalso be used to automate the process even further, providing a fully compliant and paperlessenvironment. Offered with a HPLC/GC column cabinet, the column organizer software system is theideal integrated software/cabinet solution that facilitates easy and efficient column management.  Consumable Inventory Management SoftwareNovatek’s Consumable Inventory Management Software is a powerful inventory managementsoftware system that accurately tracks samples, reference standards, controlled substances and narcotics,reagents, materials, compounds, specimens and other items used throughout various laboratories andorganizations. A chain of custody is maintained for the materials from the point of receipt, throughoutits life cycle and beyond. Internal/external orders and bill of materials are created directly in the systemfor easy and quick transfer of items from one location to another via serialization and bar-coding. Thisinventory management system allows users to quickly access vital information such as the physicallocation, amount, history or shipments of any lot or item in question.