Solutions

We are a company closely linked to the health sector. Living and breathing technology in highly regulated environments for over 15 years has allowed us to create solutions inspired by the experience of all our clients.

Our slogan "Building Solutions Together" is embodied by combining expert teams in regulations, processes and technology allowing you to progress between compliance standardization and agile IT innovation.

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MANTRA

TRACELINK™ VALIDATION STATUS MAINTENANCE

The use of cloud systems requires defining strategies for continuous review and validation of the system, focusing on the updates that are made as established by the cloud provider’s calendar.

In religions such as Buddhism and Hinduism, a mantra is a phrase, word or syllable that is recited so that oneself can relax. In CSV Experts we have adopted this term to give the name of the solution to one of the last headaches of the pharmaceutical industry: to keep TraceLink™ validated.

TraceLink™ is a level 4 serialization system in the cloud (SaaS) widely used for pharmaceutical manufacturers and CMO. This is upgraded constantly, which leads to a continuous obsolescence of its validation status.

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In order to respond to recurrent validation needs for cloud systems, CSV Experts offers you the ManTra service: continuous validation for TraceLink™ consecutive version releases. This includes:

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Procedure stablishing the strategy and methodology to assess and validate version upgrades.

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Documentation including the assessment and the activities needed in order to validate every version upgrade.

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Formal closure of version releases validation.

All this is gathered up in a repository where subscribers will have controlled access, and which ensures:

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  • User-friendliness.
  • Environment suitability.
    • Personnel is trained in service management.
    • Logical security is verified.
    • Confidentiality.
  • To be informed of all changes and updates.

If you have joined to cloud community and its benefits, why don’t you join the revolution for its validation?

GxPharma Cloud

The first Cloud solution For the digital transformation

Among the digital transformation, regulated companies are increasingly dependent on computer systems. Cloud solutions like GxPharmaCloud provide more elasticity, scalability, security and performance compared to traditional systems.

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GxPharma Cloud helps to improve the business efficiency and productivity in highly regulated environments. Designed to operate as a link between IT and QA, the solution is based on a private Cloud, meeting IT operation and document control requirements 21 CFR Part 11, HIPAA, GDPR, Pharmaceutical Quality System, EU GMP Annex 11, ISO 13485, ISO 27001.

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Pharmaceutical

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Biotechnology

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Medical Devices

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Veterinary

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Cosmetics

Key Areas Of The Solution

A solution under the Pharmaceutical Quality System (ICH Q10)

  • 24x7 service
  • Data storage
During established retention period
  • Application and data security
  • Backup and archive systems
  • Disaster Recovery
  • Continuous monitoring
  • Scalability
  • RPO and RTO = 0 (Active-Active Data Centers)
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  • Application and data security
  • Confidentiality
  • Privacy
  • Monitoring and Security Controls
  • HIPAA, GDPR, ISO27001 and ISO27
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PILARES DEL SERVICIO

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GxPharma Cloud ofrece una gama de servicios modulares desde la nube. El perímetro cubre desde las fases iniciales de planificación hasta la operación gracias al exclusivo OaaS (Operation as a service)

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IaaS

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Paas

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For more information about GxP Pharma Cloud, see our brochure

More Information
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GxPharma Cloud

La primera solución Cloud de transformación digital para la industria farmacéutica

En medio de la transformación digital, las empresas reguladas dependen cada vez más de los sistemas informáticos. Las soluciones en la nube, como GxPharmaCloud proporcionan mayor elasticidad, escalabilidad, seguridad y rendimiento en comparación con los sistemas tradicionales.

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GxPharma Cloud contribuye a mejorar la eficiencia y productividad empresariales en entornos altamente regulados. Concebido para operar como nexo entre las áreas de IT y QA, la solución se articula en forma de Cloud privado cumpliendo con los requisitos de operación IT y control de documentos 21 CFR Parte 11, HIPAA, GDPR, Sistema de calidad farmacéutico, EU GMP Anexo 11, ISO 13485, ISO 27001 e ISO27018

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Farmacéutica

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Biotecnología

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Medical Devices

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Veterinaria

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Cosmética

SABER MÁS

EJES DE LA SOLUCIÓN

Una solución bajo sistema de Calidad Farmacéutico (ICH Q10)

  • Servicio 24x7
  • Almacenamiento de datos.

 

Durante periodo de retención establecido
  • Seguridad de las aplicaciones y los datos
  • Sistemas de backup y archivo
  • Disaster Recovery
  • Monitorización continuada
  • Escalabilidad
  • RPO y RTO = 0 (Data Centers Activo-Activo)
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  • Seguridad de las aplicaciones y los datos
  • Confidencialidad
  • Privacidad
  • Monitorización y Controles de Seguridad
  • HIPAA, GDPR, ISO27001 e ISO27018
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  • Seguridad de las aplicaciones y los datos
  • Confidencialidad
  • Privacidad
  • Monitorización y Controles de Seguridad
  • HIPAA, GDPR, ISO27001 e ISO27018
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GxPharma Cloud ofrece una gama de servicios modulares desde la nube. El perímetro cubre desde las fases iniciales de planificación hasta la operación gracias al exclusivo OaaS (Operation as a service)

Si desea más información sobre GxP Pharma Cloud, consulta nuestro brouchure

Más Información
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