Cloud Based Computer System Validation – an Easier Path?

If you have ever worked for a Pharmaceutical or Medical Device company, you know how painful, time consuming and expensive it can be to meet FDA regulatory requirements for Life Sciences, aka 21 CFR. Granted, it’s incredibly important for patient safety, that companies making drug products and medical devices adequately test (i.e. “validate”) their products. Per FDA regulations, it’s incumbent upon manufacturers not just to test the final product, but also to test any related software that could impact product quality and consumer safety. So things like Manufacturing software modules, Quality Control modules, Clinical testing software, etc. are all squarely in scope for FDA validation.

For anyone new to this topic, the Validation process can be a bit like a best practice software implementation methodology on steroids. The time and expense to perform these levels of documentation and testing can often be overwhelming. For instance, among other things, the process involves: performing a risk assessment (of what could go wrong); preparing detailed user requirement documents; creating test scripts; meticulously documenting test results with print screens; creating test script traceability matrices; tracking defects and mitigations. It even involves documentation of the installation and testing of servers and base software packages to prove the system foundation was properly built and installed. Once your system is live, you then also need to have very strong change control, security, incident resolution procedures to ensure your system stays in a validated state. Anyway, you get the picture here. If you like to write, software validation engineer is the job for you! 😀.

At Apps Associates, we have been implementing Oracle Cloud ERP solutions for many of our Life Science clients. As Cloud computing and SaaS (software as a service) replace on premise systems, we see a lot of efficiencies leveraged by our clients. While the benefits of Cloud Computing have been widely known for quite a few years now (subscription based pricing, no infrastructure costs, configurable solutions, etc.), what has been perhaps less obvious, is the benefit related to computer system validation. Let’s take a look at some of these benefits:

Better Quality:

• Oracle ERP cloud solution is built using standard, repeatable SOC2 processes in consistent, single tenant virtual instances. As such, it is much less likely (than on premise servers and software) to be installed with defects or fall behind in security updates and patching.
• The building and testing of hardware and base software components is performed by Oracle Support specialized staff. So, clients don’t have to hire special staff or risk using inexperienced personnel to build it.
• The International Society for Pharmaceutical Engineering (ISPE) Good Automated Manufacturing Procedures (GAMP) considers configurable application software (like Oracle Cloud) to be lower risk (GAMP Category 4).

Faster time to Value:

• With Oracle ERP Cloud, there are no time consuming hardware procurement, installation and validation testing cycles. You can get started with your implementation project right away.
• The prebuilt workflows based on modern best practices take less time to implement and tweak than typical on premise solutions.
• A Cloud type iterative, agile implementation methodology (like ours at Apps Associates) results in faster end user adoption.
• Quarterly releases for new functionality and patching deliver earlier, continuous innovation than on premise systems, whose upgrades are typically delayed for several years due to the enormous cost of implementation and validation testing. The new features are delivered “turned off” in separate Development, Test and Production instances with time lags in between to allow for testing and adoption.

Reduced Validation Costs:

• Configurable, best practice based Cloud solutions like Oracle require no customizations which can be costly to implement, maintain and validate.
• With continuous quarterly patching, there are no major upgrade costs. Quarterly enhancements are easy to consume as you go.
• At Apps Associates, our Release Management team leverages automated testing tools to regression test any new releases. This significantly cuts down ongoing validation / testing costs.

In recent years, the FDA has been a proponent of risked based validation testing. In 2021, we are likely to see even stronger endorsement of this concept as part of their upcoming Computer Software Assurance announcement. I suspect a lot their thinking is being influenced by the reduced risk profile of Cloud based solutions like Oracle ERP Cloud.

If you’d like to talk more about this, drop me a line at [email protected].

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