For years we’ve heard about the benefits of moving to the cloud. Lower costs, staying current with the latest technology, and scalability as your company grows certainly give you a competitive advantage. However, for regulated industries, moving Quality Management Systems to the cloud raises concerns about validation and compliance, especially around privacy regulations. These challenges are now being met with robust solutions that take compliance to heart, so that moving to the cloud is easier, and more secure, than ever before.
When moving your Quality Management Solution to the Cloud, cost savings come from moving away from in-house infrastructure like data centers and servers, and transferring that cost to an operational expense (OpEx) in subscriptions for cloud services. In choosing your cloud solution, there are two options:
- Software as a Service (SaaS): go to a new multi-tenant software solution
- Infrastructure as a Service (IaaS): take your existing software solution with you
Software as a Service (SaaS)
There are many benefits to going with a SaaS-based QMS solution like Stratas EQMS or TrackWise Digital (on the Salesforce platform). These solutions provide all-inclusive subscription licensing that reduce both initial investment costs and year-over-year maintenance. They also provide fully validated out-of-the-box systems that are maintained and upgraded to the latest and greatest version by the software vendor. All that is left for the customer to do is to implement minor configuration changes for their business process, and complete PQ/UAT level testing.
SaaS solutions are great for first time QMS solutions, small to medium sized organizations, and organizations with minimal custom needs. However, SaaS may not be the right choice for your organization if you have to consider a challenging migration of data from an existing on-premises QMS, or to keep the existing system in an archival mode for the duration specified by regulations. Additionally, out-of-the-box solutions do not afford significant changes to functionality, and customization can be restrictive.
Infrastructure as a Service (IaaS)
If your organization needs customization, data, and functionality in your current QMS solution, why not take it with you?
Infrastructure services like Amazon Web Services provide a flexible and scalable platform for your existing QMS software. Leveraging your existing initial investment on licensing, configuration and development, you can move your existing software to servers in the cloud during your next upgrade cycle.
With proper Cloud Architecture of the server images, features of IaaS become available, like:
- Auto-healing with continuous uptime
- Auto-scaling – adding and removing servers to handle different capacity of users at different times, to save costs
- Quick expansion of capacity – easily add servers to increase and scale to a larger system
- Managed database backups and disaster recovery
- Managed system across multiple regions
Security is a primary concern for anyone making the move to the cloud. In regulated industries, security is at the forefront of everything IT Operations does. Hesitation to migrate to the cloud typically stems from concern around ownership and access to your data. In on-premises systems, the data is contained to your buildings and security is more easily assured. But, what about in the cloud? Especially multi-tenant SaaS? Where is your data, who owns it, and who can access it?
For the latest generation of multi-tenant SaaS solutions, access control is central to maintaining the separation of customers and their data. Every SaaS QMS has contractual agreements and security controls in the system to ensure that only your users have access to your data, that your data is contractually yours, and have validated the system to prove it. From the ground up, these systems have been designed to ensure the security of your data, usually including the latest security measures, like multi-factor authentication and encryption.
For IaaS, especially Amazon Web Services, your Virtual Private Cloud can be as open or closed as your cloud architects design it to be: Direct Connection to your network only, access through a VPN tunnel, or open to the internet but requiring multi-factor authentication. Amazon is a trusted platform; they secure data for financial institutions as well as government agencies, including the FDA.
Validation and Compliance
That’s right, even the FDA has moved to the Cloud! As life sciences and regulated industries moved to the cloud, new standards for validation of virtualized systems were developed. At every level, from the underlying infrastructure like AWS (typically the host for most IaaS and SaaS software), to the software itself, these services come with validation documentation. AWS is fully validated as an infrastructure platform, with a full suite of documentation to prove its compliance.
For SaaS vendors, it is in their interest to make sure their software is fully validated to the OQ / functional requirement level for all their customers, and even to provide templates and suggestions for how to validate to the URS / PQ / UAT level that all customers must perform. These validations have stood up to audits, making moving to the cloud a no-brainer.
For IaaS, given that the underlying infrastructure is validated, your regular validation effort, including prebuilt scripts, can be leveraged in the cloud. For proper designs, validation of software-controlled infrastructure and prebuilt and validated images can allow QMS systems, like TrackWise, to expand, scale, heal, and maintain uptime, and even upgrade more frequently, without having to requalify the software with each change. This is a major advantage over installations in on-prem datacenters.
We are in a new generation of Cloud solutions. Take advantage of the cost benefit, while minimizing risk to your QMS, as you move to the Cloud. Whether moving to a new SaaS platform, or taking your current QMS system to an IaaS platform, making the move is a decision that will ensure your continued growth.