Cloud computing is a transformative force in regulated industries. For product development teams in medical device, pharmaceutical, and combination product organizations, cloud-based Software-as-a-Service (SaaS) is becoming a viable option for implementing previously out-of-reach product lifecycle management tools. It provides:
- Secure, external storage that reduces insourced IT cost and maintenance burdens.
- Web servers with load balancing and load-based scaling, allowing for improved computing power.
- Authentication services that ensure the solution is secure and accessed by the proper parties.
- Better deployment and data synchronization across multiple geographic locations as the changing workforce spreads globally.
Teams employing SaaS solutions reduce implementation time, cost, and data centralization efforts. However, when deciding upon a SaaS provider, organizations should be accounting for that provider’s cloud architecture. The solution needs architecture that maintains data in a safe and secure manner. SaaS servers should be able to handle multiple functions and users. Solutions also need to provide proper server functionality and storage to ensure all data is properly captured, managed, and stored. Given this, it is important to evaluate what tenancy means to an organization within a SaaS environment.
What is Tenancy?
For most organizations, tenancy isn’t exactly a priority. However, it is a crucial piece of solution deployment. Within the cloud, a tenant is any application either internal or external to the organization requiring its own secure, exclusive environment. Tenancy divides into two options, either single tenancy or multi-tenancy.
In single tenancy, every tenant’s data is separate, allowing for better database and server management. Independent databases are allotted to each customer, along with a single instance of the solution.
In a multi-tenant environment, a single software instance and its hardware infrastructure is shared by multiple users. They share a single database where all data is tagged to track ownership. Multi-tenancy is built into the clouds of many large industries; online banking, social media, and others depend on multi-tenant environments to support up to millions of users at a time.
Given the priority that data security and server/domain performance have in product development, it is easy to conclude that moving towards a single tenancy is the best approach. However, there are drawbacks to consider.
Single Tenancy is Powerful, but Falls Short
There are some advantages to single tenancy. First, it empowers a greater maximization of privacy. Because there is only one software instance per organization, there is less risk of businesses accidentally—or purposefully—accessing another organization’s data. Such data security is paramount in product development; any tampering, theft, or deletion of project data by an unauthorized party affects regulatory submission and commercialization. If a SaaS solution handles a team’s Design History File, for example, it needs to confirm that the file’s data cannot be compromised. Single tenancy guarantees better data security.
Single tenancy also has performance benefits. Because only one instance of the SaaS and its corresponding infrastructure support one organization, performance can be optimized. Organizations do not have to worry about another customer’s system affecting their own.
Where single tenancy falls short is cost and maintenance. Single tenant SaaS solutions often end up needing configuration, resulting in changes to the application’s code. When software upgrades occur, the provider must ensure upgrades are compatible with the user’s custom configurations of the SaaS environment. Even if an organization avoids configuration, they still sustain infrastructure costs for supporting their instance of the SaaS application.
In addition, because of FDA regulation, upgrades and customization must undergo validation efforts. Organizations need to be sure that the SaaS solution they employ functions in a reliable, consistent manner and complies with all necessary regulatory requirements. Adding customized validation on top of SaaS configuration incurs significant cost and time, which is a problem for smaller organizations. Some of these issues can be addressed or offset through multi-tenant environments.
How is it possible that an environment with more users could be more advantageous?
Multi-tenancy saves cost. Because multiple customers share the same instance of the SaaS application within the same environment, infrastructure and maintenance costs are lower. Hardware burden is distributed, reducing the per-user cost. Users also avoid high maintenance fees for keeping their software up-to-date; the SaaS vendor can roll out features and updates in one shared environment, reducing their own operating costs.
Multi-tenant environments also benefit organizations in regard to hardware upgrades and scalability. The total capacity of the SaaS environment increases whenever new hardware is added, servers are upgraded, and so on. All users benefit from the boost in performance with the added reduction in hardware upgrade costs.
These environments are also monitored more closely than single-tenant ones. Since multi-tenancy is more susceptible to glitches, SaaS providers are more diligent about monitoring uptime, continuity, and performance. Providers also take higher precautions in developing backups and redundancy for all data.
Single tenancy also falls behind in software innovation. Software in single tenancy often becomes limited to developing new features that may only be beneficial to a particular tenant. Some organizations might find this appealing, but it can impede their competitive edge. Multi-tenancy forces SaaS adaptation and evolution due to multiple voices providing feedback and pushing the solution’s capacities. This makes it more dynamic and responsive, directly benefitting all users.
Concerns for Multi-Tenancy
While multi-tenant SaaS is a smart solution for smaller organizations, it is still important to address some concerns prior to adoption.
Much like single tenancy, multi-tenant environments can experience setbacks in the validation process. SaaS providers typically deploy automatic upgrades and updates; while these are beneficial to the software provider, they are a burden to software validation teams within organizations. When software upgrades are done automatically, teams have to ensure that they work in relation to existing SOPs and reliably produce the same outputs as before. This diverts time and money away from critical product development activities to focus on validation. In single-tenant environments, because only one customer is using one instance of the software, organizations have greater control over implementing software upgrades.
Data security is also a major concern for multi-tenancy. While data can be separated in a multi-tenant environment, it still sits within one shared database. Organizations should consider SaaS providers who take extra measures to safeguard proper data separation and security, including partitioning and continuous environment monitoring. These ensure that data integrity is kept intact and any breach frequency is mitigated.
Furthermore, if an outside user alters the data, teams can benefit from having traceability that informs who touched the data, and when. Solutions that implement 21 CFR Part 11 regulations for electronic recordkeeping and signed electronic records in their multi-tenant architectures are of high interest to product development teams.
Deciding Between Single Tenancy and Multi-Tenancy
Medical device, pharmaceutical, and combination product development teams looking to implement a SaaS solution need to be aware of the cloud environment their data and workflows will reside in. There will always be tradeoffs in deciding between single tenant and multi-tenant environments, so the decision must be weighed carefully.
Single tenant SaaS solutions can offer better security and performance for those organizations who desire more control over their environments. However, single tenancy is often more expensive than a multi-tenant solution. For smaller organizations looking for a dynamic solution that helps them save on cost, multi-tenant cloud environments offer the best solution with premier cost savings and a more competitive place within the industry, driving innovation and growth.
To learn more about Cognition’s position on SaaS download our whitepaper, Cognition Cockpit as SaaS:
About the Author
Nick Schofield is a content creator for Cognition Corporation. A graduate of the University of Massachusetts Lowell, he has written for newspapers, the IT industry, and cybersecurity firms. In his spare time, he is writing, hanging out with his girlfriend and his cats, or geeking out over craft beer. He can be reached at firstname.lastname@example.org.