SOP RPACT Cloud Release

RPACT GmbH

Am Rodenkathen 11
23611 Sereetz
Germany
www.rpact.com

Standard Operating Procedure for RPACT Cloud Release

This SOP outlines the steps necessary to release a new version of the “RPACT Cloud” Shiny App. The process ensures that all releases meet quality standards, with proper validation and deployment to the Posit ShinyApps.io platform.

SOP-ID	SOP-RPACT-003
Title	SOP RPACT Cloud Release
Description	Standard operating procedure for releasing a new version of the RPACT Cloud Shiny App
Author	Friedrich Pahlke
Creation date	2023-08-06
Version	1.0.2
Date of modification	2024-03-20

Preconditions

Before initiating the release process, the following preconditions must be met:

Check open GitHub issues: All known bugs and critical issues reported on GitHub must be resolved and closed. No open issues should be left unaddressed.

General Preparation Steps Before Pushing to GitHub

Spell Check

Run the devtools::spell_check() function to ensure that there are no spelling errors in the documentation. This step is crucial to maintaining professionalism and clarity in the documentation.

devtools::spell_check()

Run All Unit Tests

Ensure that all unit tests are up-to-date and pass successfully. Running all tests helps to confirm that no existing functionality is broken.

devtools::test()

Calculate and Check Test Coverage

Calculate the current test coverage and verify that it meets the required threshold of > 80%. The test coverage report should be reviewed to identify any untested code areas.

covr::package_coverage()

Recreate and Check All App Components

Recreate and review all components of the app, including UI elements, server logic, and data processing scripts. Ensure that they work correctly with the new version of the code.

Push Source Code to Private GitHub Repository and Check CI/CD Pipeline

Push the latest source code in the current developer branch to the GitHub repository
Create a pull request.
Monitor the CI/CD pipeline at github.com/rpact-com/rpact.cloud/actions to ensure all automated tests and checks pass successfully.
Merge the pull request only into the main branch if the pipeline runs through without any issues

Deploy Application to ShinyApps.io

Deploy the updated Shiny app to shinyapps.io using the rsconnect::deployApp function. This will make the new version of “RPACT Cloud” available online.

appDir <- "D:/R/workspace/rpact.cloud"
rsconnect::deployApp(appDir = appDir, 
    appName = "cloud", 
    appTitle = "RPACT Cloud",
    forceUpdate = TRUE)

Follow any on-screen instructions carefully to ensure the deployment is successful. Verify that the application runs smoothly on shinyapps.io after deployment.

Post-Release Activities

Monitor Application Performance

After the deployment, continuously monitor the performance of the application on shinyapps.io. Check for any errors, performance issues, or user feedback that may indicate problems with the new release.

Document Release

Document the release, including the version number, deployment date, and any relevant notes about the release process or the state of the application. This documentation should be added to the validation documentation and stored in a secure location.

Confirmation of Execution and Review

By signing below, I confirm that all steps outlined in this SOP have been fully executed and reviewed. I certify that the procedures were followed as described, and that the results have been verified for accuracy and compliance with the relevant standards.

Name	Signature	Date

Appendix: Approach to Quasi-Validation of RPACT Cloud Usage

Overview

The “RPACT Cloud” Shiny app provides users with a graphical user interface to plan, compare, and simulate study designs that involve GxP-relevant calculations. The core computational engine behind these functionalities is the rpact R package, which has been formally validated. Therefore, while “RPACT Cloud” itself is a user-friendly interface, the critical computations it performs are powered by this validated package.

Ensuring Validated Results

To ensure that the results obtained from using “RPACT Cloud” can be considered validated, users are encouraged to follow these steps:

Use RPACT Cloud for Design and Simulation: Utilize the “RPACT Cloud” app to perform trial design, comparison, and simulation tasks. The app leverages the validated rpact package to perform all calculations, ensuring that the underlying computations are accurate and reliable.
Export Results for Further Processing: Once the desired trial design is completed within “RPACT Cloud,” users should export the results. The app provides options to export all executed R scripts in formats such as R Markdown or Quarto documents. These exports contain all the necessary code to replicate the trial design in a more controlled environment.
Render in RStudio: Open the exported R Markdown or Quarto document in RStudio, a trusted environment where only the validated rpact package is used for rendering. RStudio allows users to generate HTML or PDF reports from these documents, ensuring that the final output is created using the validated rpact package.
Consider Results as Validated: Because the calculations are ultimately performed by the rpact package in RStudio, the results generated can be considered as validated. The export and render workflow ensures that while “RPACT Cloud” provides a convenient and accessible interface, the final results adhere to the stringent validation standards required for GxP-compliant environments.

Benefits of Quasi-Validation

This approach provides a balance between ease of use and compliance with regulatory standards. Users can benefit from the intuitive interface and advanced functionalities of “RPACT Cloud” while ensuring that their final results are derived from a validated source. This quasi-validation process is particularly useful for regulatory submissions, audits, and any other situation where validated results are required.

By following this recommended workflow, users can confidently use “RPACT Cloud” in their trial planning tasks, knowing that their final outputs meet the necessary validation criteria.

© RPACT GmbH, Germany

SOP-RPACT-003

Version 1.0.2