SaaS vs Paas: The Best Option for FDA Software Validation

Moving business processes into the cloud has been a goal for many companies in recent years. Unfortunately, it can be difficult to understand the differences and benefits of the various cloud services, especially as it pertains to FDA software validation requirements. Generally, there are two models of cloud provider to choose from: Platform as a Service (PaaS) and Software as a Service (SaaS). In this article, we’ll discuss the major differences between a SaaS and a PaaS provider and share which option is the better choice for FDA software validation.

SaaS vs. PaaS: What's the Difference? 

Saas Definition: SaaS (Software as a Service) is a subscription-based distribution model in which a cloud provider hosts applications and makes them available to end users over the internet.

PaaS Definition: PaaS (Platform as a Service) is a license-based cloud hosting model where the provider hosts your hardware and software on its own infrastructure.

These two software provider options have multiple differences in terms of their major characteristics, their delivery technique, and their advantages/disadvantages. Let’s take a look at each of these categories:

Advantages and Disadvantages

Now that we’ve outlined the differences in major characteristics and delivery methods of both a PaaS and a SaaS, let’s dive into the advantages and disadvantages of each.

Software as a Service (SaaS)

Fast Launch Time

There are two main advantages when it comes to SaaS providers. First, because these services aren’t customizable, they offer a quick ramp-up and launch for new organizations. However, this means that there is little control over platform design, update schedules, or data location(s). Since a one-size-fits-all solution isn’t an option for sophisticated software, your company may be limited to specific functionality, performance, and integrations offered by your vendor. Further, the underlying platform for the system comes as is, with very little room for customer desired changes or long-term growth. Essentially, what you see the day of launch is what you get indefinitely.

Reduced IT Load

The second advantage of a SaaS is the reduced load on your internal IT team. SaaS platforms are entirely managed by your vendor, meaning you wouldn’t need to worry about backup recovery and your IT team won’t need to be involved in the management of your system. While this may be perceived as an advantage in certain circumstances, it can also be a disadvantage. The reason your IT doesn’t need to manage your SaaS system is because the platform, software, and data ownership resides entirely with the vendor. This means granting full control to your SaaS provider and possibly redefining your data security models to fit the features and functionality of your software service.

There are several other disadvantages many companies face when it comes to SaaS systems, here are some of the most common:

• • SaaS systems are difficult to validate
  • Platform is shared with multiple organizations that access the software
  • Vendor services must meet the needs of many customers, not customized to your company
  • Little to no ability to change hosting provider or move between Cloud and On-Premises

Platform as a Service (PaaS)

Increased Scalability and Customization

A PaaS vendor has many advantages in the modern software sphere. The first, and one of the most popular benefits, is the scalability and client customization these platforms offer. A PaaS offers many options regarding performance, integrations, and platform design, meaning the size and functionality of your software is nearly unlimited. Unlike with a SaaS, all the data contained in the PaaS belongs to the customer, with the vendor being merely a services provider and data processor. Your company will have full control over the way your data is managed and organized.

However, while you have full control over your data, this doesn’t mean that the IT workload is placed on your company. Hosting services are still performed by the PaaS provider, but you are granted the ability to personalize the important aspects, such as:

• • Backup/disaster recovery
  • Layers of security and related security services
  • Load balancing and availability 
  • Performance requirements, tuning and monitoring of platform and deployed software systems

Single-Tenant Resources

Secondly, a PaaS offers dedicated single-tenant resources. Whereas a SaaS is shared with multiple organizations that access the software, a PaaS is set-up for your company alone. This means that there is no possibility of cross-pollination between organizations. This leads to the primary disadvantage companies may find with a PaaS system. Since your vendor needs to spend time considering your unique business needs and possible customizations discussed in the previous section, your launch time will not be instant. The implementation time of this type of platform may take longer and be more involved than that of a SaaS.

Validation Requirements

With a PaaS, software validation is client-specific and generally performed by the vendor. These validation services can be tailored based upon your specific Quality Assurance requirements. Further, validation encompasses the entire platform: design requirements, verification, and change management are all included in your validation needs. Lastly, because your company owns all the validation documentation created for the platform and software, validation becomes much easier to defend in an audit.

The Best Option for an FDA Validated System

While there are advantages and disadvantages to SaaS and PaaS models, a PaaS vendor will provide the most benefit for companies needing a validated software system. PaaS vendors provide the following unique benefits for FDA software validation and compliance:

• Your own, dedicated single tenant platform
• GxP Platform validation
• Software validation services
• Validation artifacts
• Audit support
• Execution of change management
• Ability to control if and when you receive software updates 

For regulated companies looking to minimize validation overhead and have full control of your data in a dedicated and highly secure environment, a Platform-as-a-Service model is the best option.

The DocXellent Managed Cloud (DMC)

The DocXellent Managed Cloud (DMC) enables you to streamline your workflows while exceeding regulatory requirements, giving you more time to focus on getting products to market faster. Further, our Quality Program assures that all your regulatory concerns are built into each step of the planning, delivery, and maintenance phases of our PaaS solution to guarantee regulatory compliance. And because DocXellent is responsible for all activities and artifacts needed to prove compliance of the Cloud platform and all software deployed within it, your team won’t need to worry about validation efforts.

Move your on-site applications and data to a platform that is accessible, highly available, performant, and scalable. Request a consultation here.