Are you tasked with validating new SaaS tools or cloud services? In our latest Industry Insight, Odyssey VC CEO Oisín Curran takes you step by step through validating a SaaS offering for public cloud platforms, as well as some of the benefits of adopting cloud services for GxP use cases.
Validated SaaS Adoption
To validate a SaaS (Software as a Service) offering on a public cloud platform, you will need to demonstrate that the service meets the requirements of the relevant regulations and that it is suitable for its intended use. This may involve conducting a risk assessment to evaluate the potential impact of the service on the quality, safety, and effectiveness of your product or activity, and implementing appropriate controls and security measures to ensure compliance with the regulations.
Here are some general steps that you can follow to validate a SaaS offering on a public cloud platform:
- Review and understand the relevant regulations: Make sure you are familiar with the specific requirements of the regulations that apply to your product or activity, and understand how these requirements may impact the use of SaaS on a public cloud platform. Remember, applications should be validated & infrastructure should be qualified – so cover both aspects in your considerations!
- Assess the security and compliance of the SaaS offering: Carefully evaluate the security and compliance features of the SaaS offering you are considering. This may include reviewing the service’s security policies, data protection measures, and compliance certifications.
- Conduct a risk assessment: Conduct a risk assessment to identify and evaluate the potential risks associated with using the SaaS offering on a public cloud platform. This may include evaluating the potential impact of the service on the quality, safety, and effectiveness of your product or activity, and identifying any potential vulnerabilities or threats to the security of your data. There are many options for private, hybrid or public cloud that are dedicated to delivering on the regulations for Life Sciences so be careful on your vendor selection. Our team have some great content here that can help further.
- Implement controls and security measures: Implement controls and security measures to ensure the integrity and security of the data you are storing, processing, or transmitting using the SaaS offering. This may include implementing data encryption, implementing access controls, and regularly backing up data.
- Validate the service: Validate the SaaS offering to ensure that it is operating consistently and reliably, and that it meets the requirements of the relevant regulations. This may involve conducting testing and performance assessments, and documenting the results. With the emergence of CSA from the FDA there is a significant opportunity to lean on good quality SaaS vendors to reduce validation overhead and increase adoption rates for SaaS in GxP use cases. Our company is delivering frameworks and products to support this under our Compliant DevOps approach.
- Monitor and review: Regularly monitor the security and compliance of the SaaS offering, and review your controls and procedures to ensure that they are effective and up to date.
RoI – Return on Investment
There are several potential benefits to validated SaaS adoption that can contribute to a positive RoI, including reduced upfront costs, reduced maintenance costs, increased flexibility and scalability, improved collaboration and accessibility and, most importantly, a dramatic reduction in validation and compliance costs.
To calculate the RoI of SaaS adoption versus traditional on-premises solutions, it is important to carefully consider the specific needs of your organization and the costs associated with each option. You may want to consider factors such as the upfront and ongoing costs of the software, the cost of hardware and infrastructure, and the potential benefits of each option in terms of improved efficiency, productivity, scalability and compliance.
To calculate the return on investment (ROI) of SaaS (Software as a Service) adoption versus traditional on-premises solutions, you can use the following equation:
ROI = (Benefits – Costs) / Costs
In this equation, “Benefits” refers to the total financial benefits that you expect to receive from SaaS adoption, and “Costs” refers to the total financial costs associated with SaaS adoption.
To determine the Benefits of SaaS adoption, you will need to consider the specific financial benefits that you expect to receive from using SaaS, such as reduced upfront costs, reduced maintenance costs, increased efficiency and productivity, improved scalability, reduced validation costs and total reduction in quality findings as a secondary but significant benefit. What we mean here is that, for expertly delivered validated SaaS, you can see significant cost savings on audit findings and audit responses. You will need to assign a monetary value to each of these benefits to calculate the total Benefits.
To determine the Costs of SaaS adoption, you will need to consider the financial costs associated with using SaaS, such as subscription fees, implementation costs, and training costs. You will also need to consider any indirect costs that may be associated with SaaS adoption, such as the cost of transitioning from your current on-premises solution to SaaS and any maintenance costs but remember, in the case of validated SaaS, you will generally leverage the vendors’ validation efforts so you will reduce your own internal costs.
Once you have calculated the Benefits and Costs of SaaS adoption, you can plug these values into the ROI equation to determine the ROI of SaaS adoption.
There are several potential benefits to adopting cloud services for GxP (Good Practices) use cases in the pharmaceutical, medical device, and biotechnology industries, including:
- Improved efficiency: Cloud services can enable organizations to quickly and easily access and use the resources they need, which can improve efficiency and productivity.
- Increased flexibility and scalability: Cloud services are typically delivered over the internet and can be accessed from any device with an internet connection. This can make it easier for organizations to scale their use of the services up or down as needed, and to access the services from anywhere.
- Reduced infrastructure costs: Cloud services are typically hosted and maintained by the service provider, which means that organizations do not have to invest in hardware or infrastructure to use the services. This can result in lower infrastructure costs compared to traditional on-premises solutions.
- Improved collaboration and accessibility: Cloud services can make it easier for teams to collaborate and access resources from anywhere, which can improve productivity and efficiency.
- Enhanced security: Cloud service providers often invest heavily in security measures to protect the data of their customers and may offer security features that are not available with traditional on-premises solutions.
- Increased Compliance: Cloud vendors who specialise in validated SaaS and Qualified IaaS will provide a very scalable and cost effective compliance model that is consumed on an “as needed” basis, providing a significant opportunity to reduce operational costs, increase speed of deployment and thus increase business benefit. This is all leading to increased patient safety, product quality and data integrity – provided you choose good vendors!
Overall, adopting cloud services can offer a number of benefits for GxP use cases, including improved efficiency, increased flexibility and scalability, reduced infrastructure costs, improved collaboration and accessibility, and enhanced security. However, it is important to carefully evaluate the specific needs of your organization and the requirements of the relevant regulations when considering cloud adoption and to implement appropriate controls and security measures to ensure compliance with the regulations.