Expectation vs. Reality: Understanding Software Upgrades in EDC

Lowering total cost of ownership of EDC with native cloud SaaS

Historically, companies licensed enterprise software and then implemented it “on premise” – their own or controlled physical location, and provisioned the hardware, infrastructure and support to set it up and maintain it for employees. In this traditional world, for on-premise EDC systems, once a version of the software was purchased, you had to install it locally and stick with it until you re-purchase the software in another 3-5 years. There were no software upgrades as the cost of upgrading clinical trials was too high and patches were applied periodically to addresses bug fixes.

Software as a service (SaaS, also known as cloud computing or cloud services) is leased software fully maintained by its creator and not hosted on your physical premises. SaaS applications run in the cloud and do not require capital expenditure on hardware, networking and other support infrastructure. The introduction of SaaS brought with it the promise that software upgrades would be seamless and done automatically without needing resource intensive scheduling. However, this is far from the truth as the nature of the underlying SaaS software determines the nature of the upgrades. Traditional EDC systems today are first-generation SaaS where the software was not built natively in the cloud. Rather, they are on-premise software that have just been hosted on the cloud and made available as a SaaS. As a result, they carry with it all the limitations of on-premise upgrades. In these solutions, 3-4 releases are made available every year but the sponsor gets to decide whether to implement the upgrade. However, upon reviewing the risk-reward-cost evaluation, upgrades are frequently not activated. These upgrades are capital intensive and often require upfront planning and scheduled downtime. It requires re-validation and rigorous testing of all functionality to ensure nothing was broken after the upgrade.

The third solution is a cloud native SaaS or modern SaaS where the software has been built natively on the cloud and upgrades happen automatically without downtime. All clients are on the same version of the software and the software improves incrementally with every version across all clients.

The following 3 questions will help you to quickly understand where different technology vendors reside on true SaaS scale:

If the answer is yes, the vendor is likely catering to customer concerns about getting on a new version. As a result, when given a choice not to upgrade, many clients will choose not to and eventually fall many versions behind. Each client may be on a different version and when the customer calls the helpdesk, the entire resolution process becomes instantly over complicated. The answer to the question posed may well be version dependent. This also means that the vendor is having to cross check and track potential solutions across multiple versions of the technology. Eventually, when the customer is ready to upgrade, the quantity of change is so massive, it becomes overwhelming.

A cloud native SaaS would make it mandatory for all customers to be on the same version of the software and would upgrade it seamlessly under the covers.
Any new functionality would have a toggle that you can turn on when you are ready to use it, and would get upgraded with the next version of the software whether you use it or not.

If the answer is more than one, it likely means your version of the software will be out of sync in just a few months as the vendor keeps creating new versions of the software without you needing to upgrade. Eventually your version will be so out of sync, it may not be possible to upgrade without bringing your system down or worse there may be no migration path at all, necessitating you to migrate your data as though it were a new system purchase.

In a cloud native SaaS offering, there would be just one version of the software and all customers would be on that same version. Being truly multi-tenant, any enhancements made to the software would positively impact all customers. As a result, you will get highest quality software that automatically adds a significant number of features over time without any overhead to you.

A cloud native SaaS solution will not necessitate downtime to upgrade. The software should come pre-validated and require no significant overhead from the customer other than analyzing the list of new features to understand which ones may seem relevant and be turned on.

To summarize, applications that were built to run on-premise and then hosted on the cloud as a first generation SaaS offering has the issue that the sponsor has to bear the overhead of the upgrade. As a result, it is common for the software to fall behind in versions, and the effort required to catch up becomes prohibitive and cost of upgrade is too great when compared to the benefit. A sponsor declining an upgrade on schedule, has significant repercussions. When this is scaled to multiple sponsors, it detracts from the focus of innovation in the SaaS product. The software quality suffers because the vendor is having to address product issues that were resolved in subsequent updates/versions. This is NOT true multi-tenant, cloud software. With cloud native SaaS, everyone is on the same version.

While evaluating EDC software, knowing the difference between hosted cloud solution and a SaaS that has been built natively on the cloud can significantly lower total cost of ownership and ease maintenance.

Veeva Vault EDC is a true multi-tenant solution built natively on the cloud. All efforts are focused on one version of the software as clients are automatically upgraded to the latest version on a regular rhythm of four releases a year. All new features have a toggle switch that is by default off and come with a fully documented impact analysis, so that clients can choose to enable new features. Whether they choose to use the feature or not, these are still maintained through upgrades. In this true crowdsourced model, the quality of software is superior as the focus is refined and efficient.

If an enhancement is agreed upon in the product roadmap, the software is revised in the next upgrade and therefore available to all clients without any extra effort or separate patches. These incremental upgrades ensure the software is maintained at the highest quality without massive changes. The typical steps followed by a client are to leverage the release notes to understand new features, review impact analysis, make an assessment and then implement the new features as needed. In addition Veeva delivers re-validation of software to meet the specific needs of life sciences, to learn more Vault Validation Product Brief.

Veeva performs full implementation qualification (IQ) and operational qualification (OQ). The sponsor receives full release notes and has access to all of Veeva IQ and OQ scripts. In test, sponsors peform testing and performance qualification (PQ) after they turn on features. The system will look and behave the same after upgrade until the sponsor turns on a feature, but the software will be upgraded.

Veeva provides a comprehensive package of validation accelerators that substantially reduces validation efforts

Benefits of Running EDC as a Cloud Native SaaS

Veeva Vault EDC is a true multi-tenant solution built as cloud native SaaS. As a result:
1. All effort and focus is on moving the technology forward rather than keeping clients thriving on varying versions of the software.
2. Crowd sourced model of quality – Veeva Vault EDC is validated for every version but everyone is on one version, the focus is refined and efficient.
3. When a software defect is found, it is fixed for everyone at one time – no separate fixes required for each client.
4. The software has incremental enhancements and fixes to defects even before the client realizes the need for it.

To find out more and get started today with Veeva Vault EDC, contact us.