May 02, 2021
CSV. You know it. You have probably done it dozens of times. You probably understand the importance of practicing it. However, it’s a very time consuming and burdensome process. Not only does it eat up your time, you’ve probably run into a range of issues around it including:
- Focusing on documentation rather than on risk assessment
- Deviations due to tester or test script errors
- Focusing on gathering evidence
- Numerous post go-live issues
- Repeating the software vendor efforts
Traditional CSV is manual and therefore error prone. You don’t get the full assurance and control you need, even after you have executed step-by-step testing, gathered the evidence and analyzed the risks.
With today’s complex platforms, you can never be fully confident that you have assessed all of the potential risks.
The problem? This may lead to observations by regulatory agencies. Based on the FDA observations database, each year approximately 90 companies receive CSV related observations.
Companies that own applications have to deal with the accompanying challenges and responsibilities.
We’re seeing this more in the last few years, as more compliant applications are moving to the cloud. Updates and upgrades are not necessarily in the company’s control anymore, which makes companies rely more on vendor validation services.
Software as a Service
Most apps today are using one of the common cloud platforms. These platforms provide the infrastructure and data centers while the apps are built on top of them to address the business needs.
Why do companies use SaaS applications?
- Lower cost of ownership - no infrastructure, maintenance or IT costs
- More reliable - 24/7 uptime
- Fast & flexible - short time to implement
Comparing SaaS implementation to a traditional solution:
With traditional solutions, you had to have on premise installation, which naturally included additional costs.
The implementation itself meant building the system from scratch, which usually took time and involved multiple iterations
You would usually create a tailor-made solution and you would need to validate the entire system.
The benefits of SaaS are infinite. SaaS apps are available online, meaning that no physical installation is necessary.
You may pick an off-the shelf product that allows you to reuse best practices from the industry. In most cases, it will allow you to do some set-up to adjust the system to your needs and make sure your users accept it. But, in the end you will probably have to validate these modifications.
Nowadays, SaaS is the preferred solution as it has more benefits and more advanced technology. However, the validation process is lagging behind technological advancements. We are still creating hundreds of pages with test steps for every system and every update.
These binders are saved for years, hard to use and aren’t accessible. In the age of tech, this is simply not a realistic solution anymore.
Digital and validation transformation
Most regulated companies still perform software validation manually and on-paper. Certain companies have started moving towards automation and implementation of the upcoming Computer Software Assurance (CSA) guidance.
Today, everyone is talking about digital transformation. Now is the time to go paperless.
The Covid-19 pandemic has shown us more than ever why digital processes are essential for any company that wants to move forward. Those who didn’t adopt new technologies lagged behind (if they survived) and weren’t able to have the agility required to ride out the pandemic.
It’s not just about handling ‘work from home’ needs. Systems are becoming more advanced and complex and therefore validating them becomes more difficult and complex as well. We need to think about how we can make the validation process more efficient and effective. This will allow us to avoid the software validation bottleneck that many companies face today.
We believe now is the time to move forward with technology and support the ecosystem with advanced tools that make the validation process more reliable, accurate and fast. This can be achieved by using automation, reducing paper-based processes and adopting methods and tools that fit modern platforms and applications’ needs and guarantee ongoing assurance of implemented applications..
Validify can help you automate the validation process of your Salesforce-based applications and move forward to the future of digital & automated validation.
Automating the risk identification process is the most important part of the process. Validify first identifies all of the potential risks and helps address them. Then, it’s easier to create a focused action plan of how to mitigate the risks. Lastly, validation documents are generated automatically by Validify, saving time and effort.
Now’s the time to start automating your software validation processes.
Validify Inc. is a Salesforce partner, the vendor of Validify, a Salesforce application that automates the risk analysis and computer system validation (assurance) processes for regulated companies, managing their product related processes on the Salesforce platform. Validify is an automated solution providing risk analysis of any Salesforce org and generating all necessary verification and validation documents based on risk and other predefined, configurable parameters. Validify also provides a real-time status of your org’s compliance and identifies changes in your org automatically.
About the author
Efrat Livny is a Software Validation Expert at Validify. With years of experience working with regulated companies, implementing validated systems and working with compliant information systems. Efrat holds a master’s degree in business administration, specializing in IT systems