How much test debt do you have?

The adoption of digital technology by companies to drive its strategic common goals to help improve efficiency, reduce cost, and achieve business objectives is known as Digital Transformation.  Digital Transformation is gaining more attention as companies try to do more with less resources.  The DX journey can be challenging for any organization regardless of where […]

Infrastructure qualification in the cloud

The migration of life sciences organizations to cloud environments has been swift and sure.  There are many benefits to organizations that implement and deploy validated computer systems in the cloud environment such as cost savings, high-availability, improved operational efficiency, elasticity and much more. For validated systems environments, the principles of validation in the cloud still […]

Automating Validation Testing: It’s Easier Than You Think

Automated validation testing has been elusive for many in the validation community.  There have been many “point solutions” on the market that addressed the creation, management and execution of validation testing.  However, what most validation engineers want is TRULY AUTOMATED validation testing that will interrogate an application in a rigorous manner and report results in […]

SharePoint Validation: Quality and Compliance Portals

I am often asked the question… “can SharePoint be validated?”  The short answer is YES but it often requires customization to achieve deliver compliance objectives.  The longer response requires further examination as to why people ask the question and the nature of SharePoint as a content management system.  With the release of Office 365® reaching over […]

Test automation – Necessity versus luxury

Before the pandemic, there were still a considerable number of life sciences organizations conducting all types of validation on paper.  These organizations were continuing to manually sign validation documentation on paper and scan in the signed results.  They resisted the use of electronic signatures or any automation that would drive efficiency and greater compliance.  These […]

Can Microsoft Azure Be Validated?

The text book definition of computer systems validation (paraphrased) is “documented evidence that a system performs according to its intended use”.  The FDA uses the definition “…Validation is a process of demonstrating, through documented evidence, that <software applications> will consistently produce the results that meets predetermined specifications and quality attributes.” Using the FDA’s definition, one […]

Installation Qualification (IQ) in the Cloud

Installation Qualification (IQ) is designed to ensure that systems are installed in a consistent, repeatable manner.  For on-premise systems, validation engineers typically install enterprise software from pre-defined vendor media.  Formerly, media was inserted into corporate servers and the full installation process is documented.  The purpose for installation qualification sometimes gets lost in the weeds.  Given […]

Can Cloud Applications Be Validated?

Cloud applications are being deployed within life sciences Enterprises at a rapid pace. Microsoft office 365, Microsoft dynamics 365 and the cost benefit of deployment of other such applications are driving the adoption of cloud applications for regulated systems. The question that is always asked is can cloud systems be validated? The reason for the […]

How Vulnerable Is Your Validated System Environment?

If you are a validation engineer reading this post, I have a simple question to ask you.. “How vulnerable is your validated systems environment?”  Has anyone ever asked you this question?  How often do you think about the impact of a cyber threat against your validated computer system?  I know… you may be thinking that […]