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 […]
Validating Microsoft Dynamics 365: What You Should Know
Microsoft Dynamics 365 and Azure are gaining popularity within the life sciences industry. I am often asked the question about how to validate such a system given its complexity and cloud-based nature. The purpose of this blog post is to answer this question. The outline of this blog post is as follows. Understanding the Changing […]
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 […]
5 Ways to Revive Your CSV Validation Process in 2018
If you are like most veteran validation engineers, you have been conducting validation exercises the same old way. You have been gathering user requirements, conducting risk assessments, developing test scripts (most often on paper) and delivering validation documentation and due diligence as required by current global regulations. Validation processes have not changed very much over […]
Cloud Validation Strategies
If you were to ask me 10 years ago how many of my life sciences clients were deploying systems in the cloud environment I would’ve said may be perhaps one or two. If you ask me today how many of my clients are deploying cloud’s technologies I would say most all of them in one […]
