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 […]

Ad hoc testing and software assurance

As a validation engineer with over 30 years of experience, I am well aware of the need for rigorous testing of software applications to ensure their readiness for production use.  The new software assurance methodology promoted by the US Food and Drug Administration endorses the concept of ad hoc testing. In today’s environment where cloud […]

Mastering software assurance a practical approach

The FDA has announced a new approach to computer systems validation.  The FDA will no longer use the term ‘Computer Systems Validation’ anymore or for that matter ‘Independent Verification and Validation (IV&V)’. The new name is ‘Software Assurance’.  So what is Software Assurance and why do you care? Life sciences companies are experiencing a technology […]

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 […]

Accelerating validation for Acumatica ERP systems

In case you haven’t heard, Acumatica has been listed in Gartner’s magic quadrant as one of the leadingERP systems on the market. The system includes an innovative X RP platform that includes the fullgamut of supply chain functionality including Financial Management, Warehouse Management, OrderManagement, Project Accounting, CRM, Payroll, Construction Management, Point of Sales, InventoryManagement, and […]

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 […]