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InstantGMP PRO en Español

Software todo-en-uno de fabricación, inventario y gestión de calidad

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InstantGMP PRO en Español proporciona una integración de extremo a extremo de todos sus módulos

InstantGMP PRO en Español proporciona un sistema integrado de fabricación, inventario y calidad de principio a fin, desarrollado para cumplir con los estándares de la ICH (Conferencia Internacional de Armonización), las regulaciones de la FDA (Administración de Alimentos y Medicamentos) y las Buenas Prácticas de Manufactura (GMP).

Esta solución integral de software en la nube está diseñada para los procesos de fabricación en la industria farmacéutica y en otras industrias reguladas, con flujos de trabajo incorporados que ayudan a mantener el cumplimiento normativo.

Características destacadas de InstantGMP™ PRO en Español

Este software todo-en-uno garantiza una estricta adherencia a las normativas gubernamentales durante todo el proceso de producción, ofreciendo una amplia gama de funciones innovadoras y módulos especializados.

Registros Electrónicos de Lotes
  • Crea y mantiene registros electrónicos de lotes con control de versiones, escalabilidad y trazabilidad, para promover el cumplimiento normativo y la eficiencia
  • Supervisa el inventario y los materiales utilizados en la producción, ayudando a prevenir errores relacionados con la escasez de ingredientes o discrepancias
  • Contribuye a garantizar que todos los procesos de fabricación cumplan con los requisitos regulatorios, incluidas las Buenas Prácticas de Manufactura (GMP
  • la seguridad de los registros y las aprobaciones
  • Mantiene un registro de auditoría completo, documentando todas las acciones y cambios realizados dentro del sistema, lo cual resulta valioso para auditorías e inspecciones regulatorias
  • Proporciona acceso con un solo clic a los registros de equipos, registros de salas e inventario, para completar y verificar las entradas requeridas durante la producción por lotes

Highlighted InstantGMP PRO Features

This all-in-one SaaS ensures strict adherence to government standards throughout the entire production process, with a diverse array of innovative features and specialized modules.

Electronic Batch Records

  • Creates and maintains electronic batch records with version control, scalability and traceability to promote compliance and efficiency.
  • Tracks inventory and materials used in production, helping to prevent errors related to ingredient shortages or discrepancies.
  • Assists in ensuring that all manufacturing processes adhere to regulatory requirements, including Good Manufacturing Practices (GMP).
  • Includes electronic signature capabilities to ensure the authenticity and security of records and approvals.
  • Maintains a comprehensive audit trail, recording all actions and changes made within the system, which can be valuable for regulatory audits and inspections.
  • Provides one-click access to Equipment Logs, Room Logs and inventory for completion and verification of required entries during batch production.

 

Inventory Management Module

  • Enables real-time, precise tracking of inventory levels and movement for raw materials, intermediates, and finished goods.
  • Ensures regulatory compliance through traceability and documentation of inventory transactions.
  • Integrates seamlessly with Material Planning for timely availability of raw materials.
  • Incorporates user access controls to safeguard sensitive inventory data.

 

 

Quality Management

  • A complete system for quality assurance and documentation for pharmaceutical, biotech, dietary supplement and CBD/hemp industries
  • Helps manufacturers easily manage specifications for verifying the identity of incoming and outgoing materials
  • Make accuracy and compliance more efficient in an easy to understand, structured format.
  • Available as a stand-alone software called InstantGMP™ QMS, or as a module that fully connects between the Electronic Batch Records, Inventory Management, and Document Management modules.

Learning Management

  • Create, organize, and manage curricula with options for uploading course materials, setting prerequisites, and defining course structures
  • Create and administer assessments, quizzes, assignments, and exams with various question types and grading options
  • Prepare training assignments that are automatically assigned as new employees are hired
  • Onboard and train new employees quickly and effectively
  • Monitor progress through courses, track completion status, and view grades or scores
  • Keep existing employees up-to-date with procedures and protocols
  • Stay organized with training and documentation of training logs important for remaining compliant with FDA and GMP guidelines

Report Tool

  • Defines queries using a visual interface, and the Report Writer translates these queries into SQL commands to interact with the database
  • Provides a visual query builder interface that allows users to design queries without writing SQL code manually
  • Simplifies the query creation process and makes it more accessible to users without extensive SQL knowledge.
  • Offers predefined report templates that users can leverage to create professional-looking reports quickly
  • Supports data visualization features, allowing users to present query results in charts, graphs, or other visual representations
  • Provides various export options for generated reports, including formats such as PDF, Excel, CSV, and HTML

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Additional InstantGMP PRO Features Section

InstantGMP PRO simplifies the documentation and approval procedure for quality processes. It provides inventory control, streamlines production, and elevates the overall quality of finished products while ensuring unwavering GMP compliance.

Electronic Batch Records​ Inventory Management​ Quality Management​ Document Management​ Equipment Log​ Learning Management​ Report Tool Bar Code Scanning​ Split Lot Receipts​ Pick List​ Scale Integrations​ CData Specifications​ Vendor Management​ Room Logs​ Dynamic Fields

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