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SaaS

IaaS Infrastructure as a Service enables organizations to leverage economies of scale and specialization to setup cloud infrastructure, which is vendor managed versus building out an environment on-premise. IaaS allows companies to put some of their workloads in the cloud, enabling companies to focus their time on more mission-critical items. PaaS Platform as a Service provides organizations with a full suite of services, including the infrastructure to host software and applications, as well as...

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Tailor-made for Life Sciences, ValidateMyApp is a 100% paperless platform to manage the full GxP computer system lifecycle. As a GxP implementation project manager, you need to communicate the status of your projects and the progress it's making toward milestones to a wide variety of stakeholders from functional SME's to executives, each with varying levels of information needs. While your development team wants to manage the...

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This is the first article in a series about cloud GxP validation considerations, best practices and tools .  Every day, enterprises grapple with the challenges of learning to do business faster, at scale, and reduced cost. In response, they are embracing cloud solutions throughout the enterprise to meet this need, but there are risks to address when the application is intended to support GxP processes....

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Simplify the Computer Systems Validation process with ValidateMyApp. It's not just electronic. It's smart too! Want to learn more? .button { background-color: #4CAF50; border: none; color: white; padding: 20px; text-align: center; text-decoration: none; display: inline-block; font-size: 16px; margin: 4px 2px; } .button1 {border-radius: 2px;} .button2 {border-radius: 4px;} .button3 {border-radius: 8px;} .button4 {border-radius: 12px;} .button5 {border-radius: 50%;} Request a Demo ROQMetrics, Inc, 701 E Santa Clara...

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Enrich your computer system validation efforts with ROQMetrics professional services. Assessment   Assessment of your current state GxP system for adherance to 21 CFR Part 11, good SDLC practices and more.   Project Management Management of your compliance projects to assure your projects stay on track and implemented efficiently while meeting business and quality objectives. Timeline Budget Risks Isues Etc.   Validation   Manage the validation of your compliance projects to assue that solutions are implemented in compliance with regulations...

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          Computerized System Validation       Computerized system validation (CSV) is the documented process of assuring that a computerized system works as intended in a consistent manner. The validation process begins with the system requirements definition and continues until system retirement and in accordance with e-records regulatory retention rules.       The FDA requires the following types of software systems to be validated.       Software used in the production of products under FDA regulation. Software used...

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COMPUTER SYSTEMS VALIDATION IN THE CLOUD – THE BASICS   There is an upsurge of interest amongst pharmaceutical, medical device manufacturer to move validated applications to the cloud.  These applications often support Quality, Safety, and Clinical processes in accordance with FDA regulations.  Although there is a wealth of information available regarding the validation of on-premise applications very little information is shared about validation in the cloud.    Below are 3 simple tips that will hopefully help...

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Understanding SaaS Validation

Understanding SaaS validation and what it means for your migration. SaaS is a means of delivering software applications in a whole new way as a service. Well its not new, but combing the cloud with the concept of Commercial off the Shelf Software (COTS) or packaged software is certainly the latest trend. Delivering and managing these SaaS packages in the cloud offers many benefits. Some examples...

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