Por Novatek International
¿Quién utiliza este software?
Quality Management Quality Assurance Quality Control (includes microbiology and chemists) Managers and Supervisors (Pharmaceutical Labs) Metrology
Valoración media4 reseñas
- En general 4 / 5
- Facilidad de uso 3.5 / 5
- Atención al cliente 4.5 / 5
- Relación calidad-precio
Detalles del producto
- Versión gratuita No
- Prueba gratis Sí
En la nube, SaaS, web
En directo en línea
En horario ininterrumpido (atiende un representante)
Datos del proveedor
- Novatek International
- Fundada en 1996
Sobre Nova-CPM Calibration
NOVA-CPM provides laboratories and manufacturing facilities with the functionality to track the status of their instruments, manage their equipment, and maintain all of its associated records for calibration and preventive maintenance. In addition, NOVA-CPM is completely 21 CFR Part 11 compliant.
Funciones de Nova-CPM Calibration
- Creación de informes de datos estadísticos
- Gestión de la conformidad
- Gestión de manómetros
- Gestión de varias estaciones
- Historial de dispositivos
- Impresión de etiquetas
- Instrucciones de calibración
- Lecturas de medición
- Notificación si se exceden los límites de tolerancia
- Programación de calibración
- Seguimiento de fechas de vencimiento
Las reseñas más útiles de Nova-CPM Calibration
Revisado el 29/10/2009
Comentarios: We have had a very positive experience dealing with all of the Novatek staff. They are very knowledgeable professionals, who make a concerted effort to satisfy customer needs. Our IT department was impressed with the way they handled the software installation and IQ/OQ validations. My technical staff found it easy to learn the basic use of the software, although we are still "discovering" tools that we did not notice at first. The Novatek technical representative has been extremely helpful whenever we asked for assistance, and especially in giving us different approaches to entering some of our unusual test protocols for easier data analysis.
Puntos a favor: This module is great for scheduling, tracking, and electronically approving stability test data. The trending feature and Arrhenius estimates of shelf-life have worked well for us, and several of our reports have been favorably reviewed by the FDA. Multiple lots can be selected to trend in the same graph. The software also offers ample flexibility for creating individualized report formats. Another nice feature is the modular construcion of the database which allows you to establish a number of different test protocols, which then can be selected for future studies without re-entering all of the specific details of the test plan.
Contras: (Changing a con into a pro): We knew at the outset that the module was not designed for multiplex data (Our DNA typing and Ab detection tests measure ~100 analytes simultaneously, with mixed high and low experimental values due to oligo probe or DNA sample variability, Ab avidity/titer and individual specificity). Initially we utilized the software to analyze only selected parameters (expected positive reactions). Later, through in depth discussions with the Novatek technical and programming staff, we co-developed a customized approach to overcome these limitations. I think this will result in a unique analytical tool for trending and analyzing mutivariate stability data from complex assays using mutiplex platforms.
Revisado el 7/10/2009
Stability program is adequate and much better than nothing
Comentarios: Suggest that Excell and word output be more useful rather than work-arounds so that it looks readable in Word and Excell but can't be easily modified.
Puntos a favor: The fact that data are captured and cannot be altered without clear controls and documentation.
Contras: The fact that there is essentially no export or import features and that the report format cannot be modified.