March 01, 2020
Cloud technology is an enabler for ongoing process improvements, consumer end-product price reduction and is a part of the ongoing Industry 4.0 revolution. Regulated industries, such as life science, food & beverage, cosmetics and tobacco are often very conservative when it comes adopting new IT systems and trends. Cloud computing is no different, although recent years have seen a shift in adopting cloud-based technologies in these industries. This change has led to critical systems, such as Electronic Quality Management Systems (EQMS), now also being cloud-based.
But what about validation of cloud-based systems?
While off the shelf EQMS vendors often provide it with a set of validation documents, sometimes referred to as a “validation package”, any modifications made during the implementation project are usually not included in that package. This also means that these changes are not assessed by the vendor when the cloud platform or application are periodically upgraded.
Let’s take Salesforce as an example.
Salesforce has three planned push releases a year to enhance the platform and solve known issues. Organizations using Salesforce do not get to choose when to upgrade their Salesforce platform, but rather notified by Salesforce in advance when these changes will take effect on their sandbox and production orgs. Other apps installed on top of a Salesforce org, such as Electronic Quality Management System (EQMS) apps, usually receive at least 3 updates per year as well for the same purpose. An important part of keeping systems compliant with regulatory requirements is performing an impact assessment and potentially validate changes resulting from these updates, making sure an organization’s specific process design remains intact.
Computer system validation (CSV) is key in ultimately maintaining end-product safety, but the traditional manual method of conducting it has a few very painful aspects:
• Resource Consuming – Companies often spend 30% of a project’s cost on validation activities and these costs continue to pile up after go-live, with ongoing validation costs. The process involves many resources, it is tedious and repetitive.
• Error Prone – Current process is mostly manual, depends on consultants’ or administrators’ experience and knowledge and does not provide consistent deliverables. Due to these factors and the fact that it is very human dependent, the process may have several iterations.
• Time Consuming – Companies often spend months on validating IT systems, postpone deadlines and deployments.
• Expensive – The process is expensive in FTEs/consultants costs, lost time and delays.
The disadvantages of the current process are obvious and with so many upgrades a year, it may become a crucial factor for companies considering moving to the cloud.
Moreover, there are other aspects which are the result of all these drawbacks: companies already using cloud platforms refrain from upgrading systems, postpone deployments of new features and / or avoid performing periodic assessments to their IT systems. The latter may lead to regulatory exposure during audits conducted by authorities.
These are the reasons we have developed VALIDIFY, an innovative automated application for Salesforce based applications that helps regulated companies keep their Salesforce orgs compliant with GxP regulations at all times.
Validify is an automated solution that provides risk analysis of any Salesforce org and generates 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
Gal Barnea is a Co-Founder of Validify. With over 13 years of industry experience managing global accounts, leading international deployment teams, analyzing, designing and validating IT Quality systems for regulated companies such as life science, food & beverage and cosmetics, Gal is heading customer success at Validify. Gal holds a master’s degree in business administration, specializing in IT systems and is PMP certified.
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