![]() ![]() SaaS would then offer all that and the specific software application to boot. PaaS would offer all that and additionally server operating system(s), middleware (such as load balancing software, malware protection, etc.), and runtime applications such as databases. Going from top to bottom, IaaS is a service offering typically offering server hardware, server virtualization, data storage, and networking. It has been demonstrated that the data collected through the routine use of cloud software can be immensely valuable, and there’s the added bonus of what insights could be gained when Artificial Intelligence (AI)/Machine Learning (ML) is applied to these big data sets.Ĭurrent commercial offerings are often categories into three categories: Vendors can monitor software use, responding to bugs much more quickly, and can make improvements based on how users are actually using the software, without any additional overhead for the user. With cloud software, vendors can push new features to users without any downtime or need for manual upgrading, installation, etc. Vendors and customers alike want the advantages that cloud software bring.Īnd what are the main advantages? It’s all about distribution. ![]() It should also not be surprising that cloud software has made it’s way into compliant industries such as medical device, pharmaceutical, and biologic manufacturing, which is the focus of this blog. Cloud software has significant advantages for users and vendors alike, so it is no surprise that it has become the standard for modern personal and business software applications. Cloud software is characterized by running strictly in a web browser no software is installed on a client’s local hard drive. Hello good people of the world! Today’s post is the first in a series on compliant software in the cloud. It also falls into the trap of including at least some non-human readable data. I find it strange that the audit trail would not be available in real-time, and think this could introduce some compliance risk. There is no interface for audit trail, instead it is automatically exported a protected Excel file every 28 days. This could be a compliance risk.Īnother thing I noticed is the audit trail functionality. This results in end-users not creating a configuration specification and not testing the configuration to their specific intended use. I don’t know how they consider this software non-configurable, because there is a lot of configuration options that change how it functions, including workflows. GAMP category 3 is commerical-off-the-shelf (COTS) non-configurable software. The first thing that struck me with the compliance aspect of Montrium’s offering is that they have categorized their Connect SOP (which is the brand name for the Document Management Module) as GAMP category 3 software. I found myself having to wait minutes sometimes for items moving through a workflow to pop up in my task list. The application won’t feel as snappy as modern websites, and you’ll see page reloads for things that would be handled by a component re-render in more modern applications. ![]() That said, Sharepoint also brings it’s clunky user interface and outdated Active Server Page (.aspx) architecture. I have used other eDMSs that have their own word processor and having less features can be really frustrating. I am not aware of any online word processor as fully featured as this one. The primary advantage I see, in comparison with other electronic Document Management Systems (eDMS), is that Sharepoint uses Microsoft’s Office Online suite, and arguably the world’s best online word processor: Word. The first point I’ll make is having the application built on Sharepoint brings some significant advantages and disadvantages. I previously talked about Sharepoint Online with respect to compliance concerns here (a little out-of-date, but still relevant). What makes Montrium’s offering unique is that is it built on top of Microsoft Sharepoint. Montrium offers a number of modules in their Connect software (Document Management, Training, CAPA, Incidents, etc.) Today I’ll focus on the Document Management module. Hello good people of the world! Today we’re talking about a specific Software-as-a-Service (SaaS) product: Montrium’s Connect.
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