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FRIDAY SERVICE SPOTLIGHT – CSV Digital Transformation Roadmap

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FRIDAY SERVICE SPOTLIGHT – CSV Digital Transformation Roadmap

A computer system validation strategy to help define your success

ROQMetrics has a proven approach to help you digitally transform your computer system validation (CSV) process. We work with you to develop a holistic computer system validation strategy that connects quality and compliance goals to your IT architecture. ROQMetrics experts will help you get the most out of your digital CSV transformation using a single cloud platform, agile architecture, and proven model.

Current State Review

The first step is to understand the current state of your computer system validation strategy along with the people, processes, technology, and content/data involved currently. The output of this step is a document describing the current state and any challenges/pain points you are now facing.

Future State Vision

The second step is to clearly define the future state of your computer system validation vision, including all aspects of people, process, technology, and content. This step involves understanding future state requirements and mapping capabilities required to meet your needs.

Gap Analysis

Once the current state and future state are known, the next step is to identify any gaps between the current state and the desired future state. This step involves:

  • Confirmation of pain points
  • Identification of improvement opportunities
  • Definition of success metrics

Project Implementation

Once the strategy is in place, we can then begin the implementation project with a high level of confidence for success. Our proven agile implementation methodology addresses the people, processes, technology, and content necessary for success.

Differentiators

Faster Time to Value

ROQMetrics offers an actionable roadmap and operating model which is adaptable to your business and technical architecture needs. With our proven approach, we can assure a faster time to value and smooth transition to digital CSV optimization.

CSV Strategy Leadership

ROQmetrics provides end-to-end computer system validation expertise and an industry-leading CSV solution within Life Sciences. Visit validateMyapp.com for more details on our digital CSV SaaS solution.

  • Cloud GxP software validation experts
  • Experienced helping both large and small develop CSV strategies
  • End-to-end validation leadership from policy to delivery and maintenance

Key Capabilities

Development, implementation and maintenance of computer system validation solutions:

  • Validation Plans
  • User Requirements Specifications
  • System Specifications (Functional, Configuration, etc)
  • Installation, Operational, and Performance Qualification
  • Validation Summary Reporting