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Author: roqmetrics

Types of Change Expect Change in IT Responsibilities from Customer to Vendor Vendor’s are expected to deliver more value than ever before.  As organizations moved to leaner IT organizations, this shifted the responsibilities to outside suppliers.  Depending on where your company is, moving to the cloud for GxP workflows may have little impact, as the IT organization is most likely already experienced in working with cloud vendors. ...

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Who is accountable for the GxP cloud solution? The first time that we encountered this question, it caught the team off guard. Why would the accountability be any different, we thought. Isn't the life science company ultimately accountable for all of their systems regardless of where it is hosted? The team was faced with the challenge of explaining that ultimate accountability doesn't...

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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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Search by commonly used parameters UX excellence is essential to the ValidateMyApp design team, which is why we are introducing commonly used parameters for searching and filtering data. Searching for records is an everyday activity, so we thought we’d make it easy by displaying commonly used search parameters right where you need them—no need to open any other panels or pages. Just enter your criteria, and 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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Great News! Great News for salesforce partners - The salesforce apex debugger is here providing the ability to debug apex real-time! No more slogging through debug logs. For new partners, the Apex debugger is automatically provisioned when a partner business org is requested. Existing partners must log a case in the partner community at sfdc.co/AppXProgramTech Want to learn more? .button { ...

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Computer 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. If you are implementing a cloud-based GxP solution, one of the first things you will want to do is qualify the...

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Conference Highlights   Being a Gold Sponsor of the KENX Computer System Validation and Data Integrity Congress, it's both our honor and responsibility to share highlights from the event. The conference was attended by life sciences industry leaders, experts and professionals from across the globe.   The KENX Computer System Validation and Data Integrity conference held in Philadelphia, PA, December 9th - 11th, was packed with lots of great...

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  Governance   Governance is the process whereby organizations make important decisions, determine who needs to be involved in processes, assign accountability, and assess compliance. It is important to note that governance is not management. Instead, it is the high-level planning and control of activities. This is a critical and essential distinction. Although governance deals with decision-making and decision-makers, it does not specify or make decisions for decision-makers....

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