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
  • Enviroment suitability
              •    Personnel is trained in service management
        •    Logila security is verified
        •    Confidentiality
  • To be informed of all changed 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)

  • 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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Cornerstones

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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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Oaas

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

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Animal Data Source

The forefather automated sellout app for the veterinary industry

Animal Data Source is agile, efficient, versatile, and intuitive, allowing manufacturers to have real time and homogenized data over sales and stock levels between distributors and manufacturers.

 

The manufacturer will see, through dashboards, how, when and where their products are sold, being able to obtain valuable information for their business strategy. Eventhough the distributor can add their sales data in a simple way with the guarantees that these are correct. All functions this in compliance with the Correspondence Law.

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THE PLATFORM

 

Our pioneering SaaS Software platform is aimed at collecting sales and product stock data between manufacturers' distributors (sellout).

This solution automates and digitizes data transmission processes between partners to deliver real-time and homogenized data.

Reduce considerablemente los tiempos

Significantly reduces timing

Alerta y corrección de errores

Error alerting and correction

extrae información homogenea

Extracts homogeneous information

Mejora su estrategia de negocio

Improve your business strategy

Obten datos en tiempo real

Get real-time data

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KEY POINTS

All data is represented by very clear graphics of the main KPIs in real time. In this way, easily you will be able to see the most relevant information for the strategy of your business.

Distributors will be able to access the portal and upload sales and stock data using a template with basic data such as date, code, product name and units. It will be enough to select the supplier and the date of the data to be uploaded, and the manufacturer will have access to the update of sales and stock at the moment.

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Animal Data Source is able to check through a series of parameters the data entered to guarantee the quality of these and notifies the Distributor of errors, if any.

In addition, it quickly facilitates its correction in the form itself. Increase efficiency and reduces time.

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The app itself automatically matches products between the factory and distributors to simplify processes. In this way you will always have homogeneous information based on your usual coding.

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Webinar Animal Data Source

El equipo de Ambit BST, ha creado Animal Data Source. Una solución que automatiza el proceso de recogida de datos de ventas y stock del productos entre distribuidores y fabricantes (sellout).

Ver el webinar
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AmbitOS

We believe in versatility, which enables us to deliver and execute solutions through a team that is capable of designing, implementing and maintaining systems and processes efficiently, this is why we create AmbitOS.

 

Animal data Source integrates perfectly with this service to offer a complete answer to the needs of your business

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