August 2024
As systems are becoming more advanced and complex, validating them becomes more difficult and complex as well. However, for regulated companies, using innovative tools may include risks and concerns, leading to slow adoption of new solutions and tools.
Computer software validation (CSV) remains one of the processes still performed manually in many organizations in a long, paper-based process that takes weeks,is error-prone and expensive. Over the years it has become apparent that thecurrent CSV methodology does the job but poses quite a few challenges. It produces massive amounts of documents and tests while ignoring the fact that certain areas are riskier than others and testing should focus on those high-riskitems.
It tests everything. This takes a great amount of time and resources andbeing a manual process, may require a few iterations, often due todocumentation and script errors, not actual software failure. Not to mention the costs, which can easily get to 30-50% of the overall project costs.
Traditional CSV is perceived as a burden that companies do to pass auditssuccessfully, not necessarily improve the quality of deliverables. Companiestend to perform it only when they must, delaying new projects and the adoption of new technologies. In the era of cloud computing, where updates are usually pushed by software and app vendors regularly, customers do not always get to decide which updates they would like to embrace. Some companies consciously decide to be at risk and do not perform an impact assessment of every release.
In recent years, more companies are embracing a risk-based approach and have implemented modern solutions to digitalize and automate their processes. CSV automation can include automating at least one of the following items:
- Identification of changes released to the validated software.
- Documents generation of the validated software.
- Automatic risk recommendation based on company and industry standards.
- Automatic test execution.
In my view, automating the risk identification process is the most important part of the process. By identifying the potential risks first, it is easier to create a focused action plan of mitigation of the identified risks.
Benefits of CSV Automation
From simplifying the validation document generation process, to improving the risk management or tests execution, CSV automation can significantly reduce the time spent on keeping your systems in a continuous validation state. In addition, introducing automation to the error-prone manual CSV process can significantly improve the quality of its deliverables.
Automatic CSV for the Salesforce Platform
Validify provides an automated solution for validating the Salesforce cloud platform and applications installed on top of it. This solution reduces risks and ensures ongoing credibility. Additionally, by using Validify’s innovative solution, companies can begin the journey of implementing the upcoming Computer Software Assurance (CSA) guidance which was released by the FDA in September 2022. The table below summarizes the differences between the average time it takes to perform validation activities based on the existing manual approach in comparison to using Validify.
Validation efforts of a medium-large complexity Salesforce implementation
* Depends on individual experience and knowledge of the application
** Requires in-depth knowledge of the application, implemented processesand regulations
Based on this analysis, companies can save significant amount of time with Validify, turning a 38-52 day process into a 3 day effort. Moreover, with1 consulting day ranging anywhere from $800 to $1000, full validation will cost$30,400 - $52,000 for a medium-large complexity Salesforce implementation. Given that validation is not a one-time event for cloud-based solutions, but should rather be a recurring or on-going effort, these costs may double.
With Validify, CSV validation is an ongoing process, assuring your implementation is working as expected and providing real time status. Validify’s yearly subscription with the estimated work from the table above will cost $15,000 - $26,000 for medium complexity Salesforce implementation, saving significant amount of money while increasing credibility.
By reducing human dependency and automating the process, Validify produces consistent and accurate documents for every run by a click of a button, eliminating the need for re-runs.
Additionally, Validify is supporting a continuous validation approach,providing the assurance that the platform is working based on its intended use throughout the year, while automatically identifying changes made to the system’s setup, saving even more time and money.
About Validify
Validify is a risk and validation management platform designed to provide customers with an advanced tool for IT risk assessment and software validation. The platform was designed to automate a significant part of the risk assessment maintenance to support continuous validation process, as well as automated and customizable template-based validation document generation. Validify also provides a built-in connector for the Salesforce Platform, providing real-time status of your Salesforce compliance and identifying changes in your org automatically.
About the author
Ido Raz is the co-founder and CEO of Validify. Ido has extensive experience in providing solutions for organizations in the life sciences and other regulated industries. He led global technological and implementation teams, specializing in providing IT compliance and quality applications. He is an experienced compliance and cGMP professional and a cloud technology enthusiast.
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