Which deployment model is best suited to regulated sectors?
When managing critical environments in the pharmaceutical sector, the healthcare sector or within multi-site organisations — which may include both in the case of research hospitals or university-affiliated healthcare centres —, choosing an unsuitable deployment model for your monitoring software is not merely an IT decision.
This represents a compliance risk, a financial commitment and, potentially, an obstacle to rolling out your activities across all your sites.
The issue of deployment is raised at the start of each assessment:
Should monitoring data be stored in the cloud or kept on local servers?
For regulated sectors, this choice is far more important than it is for standard business management software. You must, in fact, take into account a multitude of significant and complex variables, including:
- FDA inspections
- Data sovereignty requirements
- Validation procedures during initial installation or following an update
- IT security policies that can make or break a deployment.
Most providers of monitoring solutions require you to adopt their approach.
Purely ‘cloud-based’ providers tell you that on-premises solutions are outdated. Server providers, on the other hand, argue that the cloud does not allow you to comply with regulatory requirements or guarantee full ownership and protection of your data – which is all the more worrying given the growing threat of cyberattacks.
The reality is more nuanced, and the correct answer depends on your specific operational constraints and compliance requirements.
The JRI MySirius solution stands out by offering both cloud-based and on-premises deployment options, giving you the flexibility to choose based on your actual needs rather than on constraints imposed by providers.
This dual deployment option is important, as it is your IT infrastructure, regulatory framework and operational model that should guide your decision, not the supplier’s technical constraints. And certainly not cost or ease of implementation.
JRI is one of the few suppliers to offer both such flexibility in deployment and such extensive and in-depth monitoring capabilities within a cleanroom environment, in order to meet the constantly evolving needs of the most demanding customers in the fields of research and manufacturing.
The real decision-making criteria that matter
Data residency and sovereignty
For public sector laboratories, defence sector contractors and organisations subject to strict IT security policies, the physical location of data is not a matter of choice. It is a requirement.
Cloud deployments generally mean that your monitoring data is hosted on servers managed by the provider, often within a shared infrastructure spread across multiple geographical locations. For many organisations subject to regulation, this is simply inconceivable.
A major research university faced this very challenge when it set out to standardise its monitoring systems across all its facilities. With over 200 research laboratories carrying out grant-funded work and handling high-value samples, it needed enterprise-wide capabilities without compromising its data governance requirements.
The institution’s IT security policy prohibited certain research data from leaving the campus networks, which made it impossible to deploy its most sensitive systems in the cloud.
Their solution involved deploying MySirius by combining several deployment models.
Critical research facilities used on-premises servers to store data within controlled networks, whilst laboratories handling less sensitive data were able to take advantage of cloud infrastructure to simplify management. This flexibility helped prevent the loss of $2 million’s worth of research samples through a predictive alert system, whilst ensuring compliance with federal grant requirements.
As their IT director pointed out: “JRI has provided us with enterprise-grade monitoring capabilities whilst taking into account the specific needs of each research group. This flexibility is unrivalled.”
On-premises deployment gives you complete control over where your data is stored. Your surveillance recordings never leave your premises, your network or your jurisdiction. This is particularly important for organisations subject to data localisation laws, those handling unclassified but restricted information, or companies whose internal policies restrict the use of the cloud for certain types of data.
Cloud deployment offers geographical redundancy and disaster recovery capabilities that are difficult to match with an on-premises infrastructure. However, this very distribution can pose compliance issues when auditors ask you exactly where your data is located and who has access to it.
Internet addiction and risks associated with availability
Cloud-based monitoring systems require a reliable internet connection to function. If the connection is lost, you will lose access to real-time data, alerts may not reach you, and your monitoring system will effectively be out of action until the connection is restored.
Furthermore, thanks to the backup mobile connection, you can continue to receive alerts in the event of a power cut or Wi-Fi outage, provided the system is connected to backup power supplies, as is the case in most modern installations.
For installations located in areas where the internet connection is unreliable, or for those that need to remain under constant monitoring in the event of a network outage, there is always a certain level of risk that is difficult to mitigate, even with the most sophisticated technologies.
JRI offers a ‘connection-fail-safe’ solution thanks to wireless devices that continue to collect your data locally and switch to offline mode to display alerts on built-in screens (LoRa SPY range) or on remote screens via Bluetooth (Nano and Nova SPY ranges). The Cleanroom module offers a full offline mode, ensuring the continuity of real-time data collection and alerts in the event of an internet connection failure.
On-premises deployments ensure that monitoring continues even in the event of an internet outage. Your sensors communicate with local servers, alerts are triggered via internal networks, and data collection continues uninterrupted.
You retain visibility and control over critical environments, regardless of external connectivity.
This autonomy is of paramount importance precisely at times when monitoring is most crucial. Power cuts often result in an interruption to internet service before backup generators take over. Natural disasters that threaten your cold chain also disrupt telecommunications.
Network maintenance windows must not result in any gaps in the monitoring of your pharmaceutical production site.
A Fortune 500 pharmaceutical company realised this whilst assessing the monitoring systems at its sites around the world.
They needed a monitoring system capable of continuing to operate during network outages, which often accompany such events that threaten product integrity. By deploying MySirius across all their sites, with on-premises servers at critical facilities, they reduced their monitoring costs by 40 per cent whilst achieving 100 per cent compliance with audit requirements across all their sites. The flexibility of the deployment enabled them to maintain monitoring during network outages at production sites, whilst continuing to benefit from the advantages of the cloud at distribution centres with robust connectivity. Once again, JRI is one of the few providers capable of delivering a deployment offering this level of flexibility, robustness and redundancy.
Cloud systems overcome this drawback through redundancy and availability guarantees. Leading cloud service providers offer a level of reliability that is difficult to match with on-premises infrastructure. However, these guarantees are of no use if your site’s internet connection is down, regardless of how reliable the cloud platform itself is.
Costs associated with validation and re-qualification
In regulated sectors, monitoring systems are not limited to simple software programmes.
These are validated systems that require
- qualification protocols
- documented tests
- and change management procedures.
The workload associated with validation varies considerably from one deployment model to another, and this difference becomes more pronounced over time.
Cloud deployments introduce a certain degree of complexity, as the underlying infrastructure changes beyond your control. When your cloud service provider updates its platform, patches security vulnerabilities or migrates to new hardware, these changes may necessitate further validation.
You should refer to the supplier’s documentation to understand what has changed and how these changes affect your validation status.
JRI offers validated cloud-based environments, specifically designed for regulated sectors, and manages documentation and change control to meet your compliance requirements. However, you remain dependent on a third party to maintain the validated status of an infrastructure over which you have no control.
On-premises deployments give you complete control over the validation lifecycle. You decide when to update software, when to apply patches to systems, and how to manage change control. This control simplifies validation, as you are not forced to react to changes imposed by software vendors. You can maintain validated systems for years without mandatory updates or migrations.
The ‘Calibration’ module in MySirius illustrates the impact of deployment models on validation. Organisations that opt for on-site deployment can maintain ISO 17025 / COFRAC / NIST-certified calibration capabilities entirely within their own controlled environment, which simplifies validation documentation and change control procedures.
A regional blood transfusion centre has achieved compliance with FDA standards without any non-conformities being identified, thanks to the on-site implementation of MySirius, which features heat mapping and core temperature modelling capabilities.
This deployment approach simplified their validation process, as all system components remained within their controlled environment. They reduced the manual work involved in data entry by 90 per cent, whilst maintaining comprehensive documentation of their validated cold chain, from collection to transfusion.
The complexity of multi-site management
Organisations with multiple sites must carry out a different calculation.
Cloud deployments are characterised by their centralised management, offering business teams visibility across all sites via a single interface. You can monitor the situation in Boston, manage alerts for Chicago and view compliance reports for San Diego without needing to use VPN connections or site-specific login details.
This sort of visibility, which allows you to go anywhere, has many advantages.
On-premises deployments across multiple sites traditionally required either managing each site individually or a complex network infrastructure to connect disparate systems. This creates an additional workload for IT teams and makes it difficult to achieve enterprise-wide visibility.
Modern platforms bridge this gap by supporting hybrid deployments. You can operate on-premises servers at each site whilst benefiting from centralised management and reporting. Monitoring data remains local, ensuring compliance with data residency requirements, whilst management interfaces provide enterprise-wide visibility.
An international logistics company took advantage of this approach when it expanded its operations from transport tracking to facility management.
The company needed to implement a standardised tracking system across all its distribution centres, whilst retaining its existing systems and meeting the validated storage requirements of its pharmaceutical sector clients. By rolling out MySirius with on-premises servers at each site, it has expanded its service offering and increased its pharmaceutical client base by 35 per cent, whilst ensuring seamless documentation of the cold chain.
The key is to understand that multi-site management and on-premises deployment are not mutually exclusive. A suitable platform offers both local control over data and enterprise-wide visibility. MySirius is uniquely positioned to meet this challenge and has a proven track record in complex environments.
Total cost of ownership over time
Cloud deployments are generally based on subscription-based pricing models, with recurring monthly or annual costs. This means you avoid initial investment in infrastructure, but you are committed to paying recurring fees for as long as you use the system.
Over a period of five or ten years, these subscription costs may exceed the total cost of an on-premises deployment.
On-premises deployments require an initial investment in servers, infrastructure and implementation. However, once the system is deployed, your recurring costs are mainly limited to maintenance and support. For organisations planning for long-term use, on-premises deployment often offers a lower total cost of ownership.
The calculation becomes more complicated when IT resources are taken into account. Cloud deployments ease the workload on in-house IT teams by entrusting infrastructure management to the provider. On-premises deployments, on the other hand, require in-house resources for server maintenance, updates and troubleshooting.
Companies with limited IT resources may find that deploying in the cloud is more cost-effective, even if the subscription fees are higher.
A regional healthcare system carried out this calculation when implementing a wireless tracking system for mobile medical equipment. The system was designed to track this equipment across several buildings whilst ensuring that the temperature of the mobile medicine trolleys was maintained.
The implementation of the ‘Mobility’ module has reduced the time spent searching for equipment by 75 per cent and resulted in annual savings of $500,000 on costs associated with lost equipment. The return on investment justified both deployment models, but their existing IT infrastructure and data governance requirements made the on-premises solution the best choice in the long term.
Hidden costs arise in both models.
Cloud deployments may incur costs relating to outbound data transfer, additional users or premium features. On-premises deployments incur costs relating to backup systems, disaster recovery and the periodic replacement of hardware. To make a fair comparison of costs, it is necessary to look beyond the initial price and take into account the full financial commitment.
Why is dual-deployment capability important?
The most significant advantage is not having to choose between the cloud and an on-premises solution. Rather, it is being able to make that choice based on your actual needs, rather than on the constraints imposed by providers.
Companies with multiple sites often require different deployment models depending on the site. Your head office might benefit from a cloud-based deployment, whilst your production sites may require on-premises servers. Your research laboratories may need local control over data, whilst your distribution centres may benefit from a cloud-based infrastructure.
Being tied to a single deployment model forces you to make compromises. Either you opt for a cloud deployment, which brings compliance risks, or you deploy an on-premises infrastructure, which proves unnecessarily complex. Neither of these compromises is in your business’s best interests.
MySirius’s dual deployment model allows you to roll out the same platform across your entire organisation whilst choosing the infrastructure best suited to each site. This means you benefit from consistent monitoring capabilities, a unified reporting system and standardised procedures, regardless of the deployment model you choose. Your team only needs to be familiar with a single system, your validation protocols apply to a single platform, and your compliance documentation refers to a single solution.
This flexibility extends beyond the initial roll-out.
As your organisation evolves, you can switch from one deployment model to another without changing platforms. An organisation that starts with an on-premises deployment can move to a cloud infrastructure when its data governance requirements change.
A cloud-based deployment can be migrated to on-premises servers if regulatory requirements become stricter or if the reliability of the internet becomes an issue.
Making the right choice for your organisation
The decision on deployment begins by taking your constraints into account, rather than your preferences.
What are the requirements of your IT security policy?
What are your regulatory obligations?
What features does your infrastructure support?
For public-sector service providers, defence companies and organisations handling sensitive data, on-premises deployment may be mandatory, regardless of any other considerations. Your decision is already dictated by external requirements.
For organisations subject to strict data localisation requirements, with an unreliable internet connection, or which are particularly cost-sensitive in the long term, on-premises deployment is generally the more sensible option. The initial investment helps to reduce the total cost of ownership and eliminates any dependence on external connectivity and changes to providers’ infrastructure.
For businesses with multiple sites, a robust IT infrastructure and a high-speed internet connection, and which favour managed services, cloud deployment often offers the best balance between performance and convenience.
You benefit from company-wide visibility, simplified management and a reduced IT workload.
For many organisations, the answer is both. Critical sites deploy an on-premises infrastructure, whilst less sensitive sites use the cloud. This hybrid approach enables organisations to best meet the specific needs of each site whilst ensuring the consistency of the platform.
The key is to choose a platform that meets your needs, rather than one that forces you to adapt to the constraints imposed by the provider. With over 269 monitoring tools and features brought together within a single, unified platform, MySirius offers comprehensive monitoring capabilities, regardless of the deployment model.
Whether you need real-time monitoring with customisable, audit-ready compliance reports hosted in the cloud, or on-premises servers that keep data within your controlled environment, the platform adapts to your infrastructure without forcing you to make any compromises.
Beyond roll-out: what really matters
The deployment model is important, but it is not the only criterion to consider when evaluating monitoring platforms. The most flexible deployment options are of no use if the platform fails to meet your monitoring needs, help you meet your compliance obligations or adapt to changes in your business.
Look for platforms that are backed by solid industry experience.
JRI draws on more than 180 years’ experience in the fields of metrology and the monitoring of regulated environments, serving some of the world’s leading life sciences companies. This experience translates into monitoring solutions tailored to the specific challenges of pharmaceutical manufacturing, healthcare operations and the management of multi-site organisations.
Consider the full range of possibilities offered by monitoring. Temperature monitoring is just a starting point.
The ‘Cleanroom’ module connects to any device via Modbus without the need to replace any hardware. It enables particle counting, differential pressure monitoring and the tracking of environmental parameters in cleanrooms within pharmaceutical and biotechnology laboratories, as well as in sterile manufacturing facilities.
The in-product temperature modelling technology enables product temperatures to be simulated without the need for invasive measurements, which is essential for vaccine storage and the monitoring of biological samples. Add thermal mapping to this, and you have one of the most comprehensive and sophisticated monitoring and compliance platforms on the market.
Assess the supplier’s commitment to compliance. Platforms designed for regulated sectors must meet your validation requirements, maintain documentation ready for audits, and provide the compliance reports you need for inspections and certifications.
The decision on deployment is important, but it is only one factor amongst many in a broader assessment.
Choose a platform that offers the monitoring features you need, meets your compliance requirements and provides the deployment flexibility to suit your infrastructure, without forcing you to make any compromises.
Your surveillance infrastructure will support your business for many years to come. Choose a deployment solution that will promote your long-term success, rather than just your immediate convenience.
And choose a provider whose platform grows with you, whether that means expanding your presence to other sites, adapting to changing needs, or evolving your deployment model as your organisation transforms.
