Optimizing Data Workflows in a GxP-Compliant Environment

Production-Ready GxP Environment Delivered

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A leading global pharmaceutical company required expert assistance to streamline its data science workflow in a way that makes sense for all its data teams.

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Appsilon delivered a tailored, GxP (Good Practice) compliant development environment that utilizes the Posit software suite.

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The updated environment utilizes Infrastructure as Code for easier compliance and audit readiness. It has also introduced centralized tools to optimize workflow and improve latency and has standardized development processes for risk mitigation and traceability.

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The Challenge

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The client had an existing environment that leveraged RStudio Desktop, but the results fell short of their expectations and it was not being fully utilized.

Their earlier implementation of Posit software faced latency issues when multiple users were accessing the data tools at the same time.

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They needed a solution that would improve their overall workflow in terms of creating code, packages, and managing data in a stable and reproducible development environment. 

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In this highly regulated industry, the environment needed to be aligned with the stringent Good Practice (GxP) regulatory requirements for the submission of new products to governing bodies and for auditing purposes. 

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It was critical that strong quality control measures be in place to minimize errors and ensure the reliability of software applications and results from data scientists’ work.

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Solution

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Appsilon started with developing an architecture that would fit the client’s needs.

The team customized and installed software from the Posit suite to augment the client’s existing installation of RStudio Desktop. The updated environment supports data science teams in creating, sharing, and managing data science assets collaboratively and securely. It also addresses the client’s concerns related to workflow optimization, latency requirements, due to multi-country accesses, and the integration of centralized tools.

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To demonstrate compliance during audits and inspections by regulatory authorities such as the PMDA, EMA, or FDA, Appsilon provided the client with GxP-compatible documentation.

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The installation now also leverages Ansible automation to provide consistent, repeatable outcomes and GxP validation. Together with other robust quality control measures, it reduces the risk of errors, bugs, and system failures to ensure the reliability and accuracy of software applications used in critical pharmaceutical processes.

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Along with deploying improvements to their infrastructure and workflows, Appsilon delivered Quality of Life (QoL) improvements that make working within the infrastructure smoother, faster, and more intuitive. 

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Appsilon delivered:

• A GxP-compliant development environment with documentation, including:
  • Architecture documentation 
  • Installation qualification (IQ) documentation
  • Operational qualification (OQ) documentation
• Installation and testing on the development server before full deployment
• Quality assurance processes
• Licensing, adapted installation, and testing for Posit Connect, Workbench, and Package Manager

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Results

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The collaboration between Appsilon and the major pharmaceutical company culminated in the successful implementation of a tailored architecture, GxP documentation, a customized installation of Posit software, and a robust quality assurance framework. 

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The client received a stable, collaborative, GxP-compliant development environment for data scientists to work together in an optimized workflow, with configuration management, that facilitates environment auditing, description and reproducibility for quality assurance purposes. The GxP processes and documents are prepared and integrated for auditing and submissions to governing bodies.   

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At the end of the project, the client’s outcomes were:

• Development environment ready for easy deployment to production
• Documentation that is compliant with regulatory requirements
• Documentation prepared in readiness for audits
• Improved responsiveness, and more collaborative use of data and compute resources
• Significant improvements in development, reproducibility, efficiency and stability
• Standardized development processes
• More streamlined data analysis in the drug development process using R

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Production-Ready GxP Environment Delivered

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The client was provided with a working GxP development environment that is in compliance with regulatory requirements, mitigates risks, and enhances quality assurance. Documentation is in place that is compliant with regulatory regulations and is prepared for audits.

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Data scientists and teams have access to more collaborative tools to optimize workflow in a stable and reproducible development environment.  The environment is ready for production deployment with little technical configuration requirements.

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Optimize Your GxP Environment for Maximum Impact

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Appsilon are experts in development environments, infrastructure, processes, and the required documentation to support audits and submissions in highly regulated industries.

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Talk to us about how we can work with you to optimize your workflow while meeting your regulatory requirements.

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