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A cloud monitoring solution with IoT temperature sensors -easy to install, change and grow

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Get the latest ELPRO Cloud Temperature Monitoring Solution

A cloud monitoring solution with IoT temperature sensors -easy to install, change and grow

Where to host a Temperature Monitoring System?

A cloud based temperature monitoring solutions consist of hardware collecting the temperature values and software evaluating the data, triggering alarms, performing reports and archiving the harvested data in a compliant manner. But where is this software running? While in the past “on-premise” was the usual answer, today more and more cloud solutions are being introduced. But what are the implications, risks and requirements of running a GxP compliant cloud based temperature monitoring solution?

What is Cloud Computing?

Cloud Computing is a service using remote servers hosted in the internet to store, manage, and process data - rather than running an application on a local server on-premise. As a rule, a distinction is made between three cloud models, which differ in the outsourced areas of responsibility.

Software as a Service (SaaS), also known as cloud application services, represents the largest cloud market. SaaS delivers (business) applications that are typically accessed directly via web browser and do not require any downloads or installations on the client side. 

Cloud vs. On-Premise

What are the advantages of Cloud Computing?

In the past years, cloud computing and cloud hosting has rapidly grown for business applications across different industries. This is due to obvious advantages:

  • Know-how to run a data centre available & accessible at Cloud provider
  • High security standards in facility, equipment, SW-tools (e.g. firewalls), processes & personnel
  • Fast and easy scalability of all resources (performance, storage space)
  • Built-in backup and recovery functionalities
  • Reduced maintenance efforts due to synergy effects.
  • Significant cost savings compared to running a software on-premise at the same security and performance levels.

What are the disadvantages of Cloud Computing?

Naturally, cloud computing also has downsides:

  • Lock-in effects resulting in dependencies on the solution provider. This requires a clearly structured and detailed agreement with a well defined exit scenario.
  • Security concerns or delegation of control: Again, this requires additional efforts to evaluate the right partner and regular audits.

But in the end it is all about cost: What are the benefits (cost savings) and what are the additional efforts (additional costs) in a cloud solution in comparison to running the software on-premise?

Cost saving potential Cloud solution

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Checklist cloud-based Temperature Monitoring

Download a summary on everything you need to know about storing temperature data in the Cloud.

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Executive Summary Temperature Monitoring

Download a summary on everything you need to know about temperature monitoring.

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Public Cloud vs. Private Cloud: What is the right model?

Cloud Computing or Software-as-a-service (SaaS) has again three sub-types differentiating if the application is dedicated to one customer or if the application is shared by many.  

Public Cloud

Application is provided by SaaS provider and used by many customers with own user names and passwords but shared infrastructure and software.

Private Cloud

Application is dedicated to a single customer. Compared to the Public Cloud, the Private Cloud is significantly more expensive since the resources need to be multiplied with each new customer.

Hybrid Cloud

Mix of public and private cloud solutions. The resources are typically orchestrated as an integrated infrastructure environment. Hybrid Cloud takes “the best of both worlds” but is more complex to overlook and manage.

Cost comparison Public vs. Private Cloud

Download our checklist which covers everything you need to know about storing temperature data in the Cloud. 

Get your Cloud checklist now

What makes a cloud based temperature monitoring solution GxP compliant?

To ensure that a SaaS Public cloud based temperature monitoring solution is GxP-compliant, a few requirements must be fulfilled:

  • The temperature monitoring solution including the database is a computerized system. To meet GxP requirements (e.g. GAMP5, Title 21 CFR Part 11), the computerized system must be validated (CSV).
  • To ensure patient safety, data must be immutable and data integrity must be protected by a multi-layer application where data becomes attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring and available over its entire life-cycle.
 
Computerized System Validation

What is a Computerized System Validation (CSV)?

A computerized system validation (CSV) is the documented process of assuring that a computerized system does exactly what it is designed to do in a consistent and reproducible manner. It follows the V-Model, which means requirements must be documented, validation and test plans written, risks evaluated in a written risk assessment, functionalities tested and documented according to the test plan and finally a validation report issued summarizing all validation efforts.

How to ensure data privacy in a SaaS Public Cloud based temperature monitoring solution?

In a multi-tenant infrastructure (SaaS Public Cloud), separate clients work on the same cloud based temperature monitoring software using their own user-names and passwords, which means they only have access to their own data and reports that are guaranteed by row-level access rights. Therefore, each line in the database is only accessible to authorized customers (see also Compliance in User Management & Authentification). 

Ensuring Data Privacy in Cloud based Temperature monitoring

 

Risks of Hosting a
Temperature Monitoring Solution in the Cloud

Five Risk Mitigation Strategies

There are many risks related to hosting a GxP-compliant temperature monitoring solution in the Public Cloud. The following gives an overview of the risks and proposed mitigation measures.

Data Safety and protection

  1. Implement security measures to protect data from unauthorized access.
  2. Back-up data to secure data from being deleted or lost.
  3. Align with privacy regulations (e.g. GDPR)

Change Management

Service Level Agreement (SLA) with clear definition of how to deal with upgrades, patches and changes:

  • Classification of changes (minor, major)
  • Notification, documentation and qualification of changes

Validation

  1. Supplier must prove, that all hard- and software components have been validated according to the GAMP5 model including validation plan, risk analysis and validation reports.
  2. IQ-documentation of the cloud software provided
  3. Provide efficient tools for qualification of customer-specific hardware components:
    1. Installation Qualification (IQ): what measurement hardware has been installed?
    2. Operational Qualification (OQ): does the measurement hardware and software configuration work together as planned?

Supplier Dependency & Business Continuity

Supplier SLA should include:

  1. committment that supplier takes care of the maintenance and assurance of the accuracy, consistency and completeness of data over its entire life-cycle.
  2. meaningful notice period prior to service termination.
  3. statement that the client remains owner of the data and that data is available for download before the service ends.
  4. statement that the performance and availability of the solution is guaranteed and that the supplier monitors the availability and performance of the solution and provides reports thereof.
  5. statement that the system and data is backed up regularly and recoveries are exercised and documented regularly.

Data Archiving

Before 2 years: Process Data is “fresh data” which is used for taking business decisions (e.g. MKT calculation of a stability study). For two years, the service provider must ensure that:

  1. Process Data is available electronically for visualizations (e.g. zoom, overlay)
  2. it must be possible to draw statistics easily (e.g. calculate MKT),
  3. it must be possible to add comments in the system and generate reports (e.g. release decision),
  4. it must be possible to export the data (e.g. to higher batch management system).

After two years: The service provider must ensure that Archive Data is available for at least 10 years and fulfils the following requirements:

  1. clearly labeled (e.g. monthly report per sensor)
  2. “human readable" form as a record (e.g. PDF/A report)
  3. stored in a secure archive (e.g. in a drive that is backed up regularly to a different physical location)

Download our checklist which covers everything you need to know about storing temperature data in the Cloud. 

Get your Cloud checklist now

Further topics to discover

Compliance in Monitoring Systems

Find all elements and features of a GxP-compliant temperature monitoring solution on this page.

GxP Compliance - Audit

More about GxP Compliance

Calibration of Equipment

Find out more about the process of a calibration and why it is even necessary to calibrate a sensor.

Sensor Calibration

More about Calibration

Qualification and Mapping

If you work with pharmaceutical products and want to comply with GMP and GDP guidelines, you must know more about Qualification.

Qualification_Mapping_Preview

More about Qualification