Tecnyca QIMS (Quality Intelligence Management System)

The complete and integrated solution of quality and compliance tools for highly-regulated environments.

Estabilidad

Con esta herramienta Usted podrá realizar de forma fácil, rápida, segura y efectiva; los estudios de estabilidad del tipo acelerado y largo plazo que solicita la autoridad regulatoria para poder obtener la autorización de comercializar sus productos.

Validación métodos analiticos

Nunca antes había sido tan fácil y rápido verificar las diferentes características de desempeño de los métodos analíticos de acuerdo con las diferentes categorías establecidas por la FDA e ICH.

CAPA

Permite automatizar información relacionada a procesos de auditoria y sistema de acciones correctivas y preventivas, en todo lo referente a:• Registros maestros relacionados para clasificación de información, programación de auditoria, ejecución de auditorias, manejo de no conformidades.

Control estadístico en proceso

Capture rápida y de forma confiable los datos iniciales de diferentes procesos productivos, y a partir de ellos, efectúe análisis y comparación de datos, cartas de control, índices de capacidad y además verifique la tendencia de sus procesos para mantenerlos bajo el estado de control.

QIMS

Based on the philosophy of Pharmaceutical Quality for the XXI, the team of specialists in Quality, Compliance and IT Information Technology at Tecnyca have developed an expert system comprised of a set of software tools allowing companies to accelerate their regulatory compliance processes and be able to reach the market faster with their products, reducing costs and increasing efficiency.

Pharmaceutical, nutraceutical and food companies, no matter their size, create a permanent data flow associated to their products’ quality. Integration, analysis, relation and practical application of this information constitute the intelligence of the organization. Tecnyca QIMS Quality Intelligence Management System is designed to manage this intelligence, adapting to your company and technological environment; it is sufficiently scalable in order to evolve in accordance to your needs and regulatory changes. It is built on a centralized network platform which can operate from Internet or directly in your servers.

Among their characteristics you will find:

  • Fast use in its simulation operation mode.
  • Foolproof response in its regulatory compliance operation mode.
  • All quality data is interconnected in its neuronal network.
  • Access security, data and process traceability are certified by the Code of Federal Regulations Title 21, Part 11.
  • Reliability since it’s validated in accordance to GAMP5 requirements. Good Automated Manufacturing Practices 5th version.
  • More than 30 specialized tools designed to work as a continuous and integrated solution.
  • Preloaded with Protocol Models and Templates, Procedures and Reports based on the requirements of regulations and guidelines in force for each application.
  • Real experts’ suggestions for setting parameters each application and interpret the results obtained.
  • Customizable interface.
  • Online support.

Portafolio de Cursos

14oct1:00 am- 12:00 pmGustavo Silva CastilloIngeniero Mecanico en Produccion Industrial1:00 am - 12:00 pm Barrio La CastellanaCalle 93 No. 45 - 25
7oct1:00 am- 12:00 pmJorge GuarnizoTécnico Mecánico General en Mantenimiento1:00 am - 12:00 pm Barrio La CastellanaCalle 93 No. 45 - 25
29sep1:00 am- 12:00 pmHarry Arce Contretas1:00 am - 12:00 pm Avenida del Valle 961
21ago - 21sepago 211:00 amsep 21Juan Pablo Hidalgo1:00 am - (septiembre 21) 12:00 pm Avenida del Valle 961
21ago - 21sepago 211:00 amsep 21Rolando Villaroel Marambio1:00 am - (septiembre 21) 12:00 pm Avenida del Valle 961

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