
SOP RPACT Validation Documentation
© RPACT GmbH, Germany
SOP-RPACT-002
Version 1.0.4
rpact_sop_002_validation_documentation.Rmd
RPACT GmbH
Am Rodenkathen 11
23611 Sereetz
Germany
www.rpact.com
Copyright © 2025 RPACT GmbH. All rights reserved.
Standard Operating Procedure for the RPACT Validation Documentation
The purpose of this document is to outline the systematic process for
generating and updating the validation documentation of the
rpact package using the rpact.validator R
package. This process ensures that the package’s documentation
accurately reflects its current state, including changes in the
codebase, dependencies, outputs, and performance metrics. By automating
these tasks, we maintain a high level of accuracy and efficiency in our
validation procedures.
This document applies to all steps involved in the creation and
maintenance of the rpact package’s validation
documentation. It covers the generation of key components such as the
NEWS section, output specifications, plot types, business object
structures, unit tests, and performance qualifications. This SOP is
intended for use by the development and quality assurance teams
responsible for the validation of the rpact package,
ensuring that all documentation is comprehensive, up-to-date, and
aligned with validation standards.
| SOP-ID | SOP-RPACT-002 |
| Title | SOP RPACT Validation Documentation |
| Description | Standard operating procedure (SOP) for creation, update, and release of the rpact validation documentation |
| Author | Friedrich Pahlke |
| Creation date | 2021-09-07 |
| Version | 1.0.4 |
| Date of modification | 2024-02-05 |
Automated Validation Documentation Steps using
rpact.validator
This section outlines the steps executed to automatically generate
and update the validation documentation for the rpact
package. The rpact.validator R package is utilized to
perform these tasks efficiently. Each step is described below with the
respective R command used.
Set Working Directories
Before running the validation functions, ensure that the working directories for the project, quality assurance, and validation documentation are correctly set.
packageProjectBaseDirectory <- "D:/R/workspace/rpact"
setwd(packageProjectBaseDirectory)
qualityAssuranceBaseDirectory <- "D:/R/workspace/rpact.qa"
validationDocumentationBaseDirectory <- "D:/R/rpact_package_docs/validation"
ignoreFilesRegex <- NA_character_Generate the NEWS Section in LaTeX Format
The createNewsTexFile function generates a LaTeX file
containing the NEWS section of the package, summarizing changes and
updates in the new version. This file is essential for documenting the
history of the package.
createNewsTexFile(outputTexFile = file.path(
validationDocumentationBaseDirectory, "9_appendix/NEWS.tex"))Create a Table of Base R Packages
The createBaseRPackagesTable function generates a table
listing all the base R packages used by rpact. This table is added to
the validation documentation, providing an overview of dependencies.
createBaseRPackagesTable(validationDocumentationBaseDirectory)Document Output Specification
The createRpactOutputSpecification function creates a
document that specifies the output generated by the rpact package,
including the structure and format of the outputs.
createRpactOutputSpecification(packageProjectBaseDirectory,
validationDocumentationBaseDirectory)Document Plot Type Specification
The createRpactPlotTypeSpecification function documents
the various types of plots generated by the rpact package. This
specification is crucial for validating the visual output.
createRpactPlotTypeSpecification(packageProjectBaseDirectory,
validationDocumentationBaseDirectory)Document Source Directory Structure
The createRpactSourceDirectoryStructure function creates
a detailed structure of the source directories within the rpact project.
This documentation is important for understanding the organization of
the codebase.
createRpactSourceDirectoryStructure(packageProjectBaseDirectory,
validationDocumentationBaseDirectory)Document Business Object Structure
The createRpactBusinessObjectStructure function
documents the structure of business objects within the rpact package.
This helps in validating the design and implementation of these
objects.
createRpactBusinessObjectStructure(packageProjectBaseDirectory,
validationDocumentationBaseDirectory)Generate Unit Tests Documentation
The createRpactUnitTests function generates
documentation for the unit tests within the rpact package. It can also
copy unit test files to the testthat directory and enforce the creation
of all unit tests.
createRpactUnitTests(packageProjectBaseDirectory,
qualityAssuranceBaseDirectory,
copyUnitTestFilesToTestthatDir = TRUE,
enforceCreationOfAllUnitTests = FALSE,
ignoreFilesRegex = ignoreFilesRegex)Create a Test Plan
The createRpactTestPlan function generates a test plan
document, specifying the planned tests and validation steps for the
rpact package.
createRpactTestPlan(packageProjectBaseDirectory,
validationDocumentationBaseDirectory,
ignoreFilesRegex = ignoreFilesRegex)Document Unit Test Results
The createRpactUnitTestResultDocumentation function
generates documentation for the results of the unit tests. This
documentation is key to validating the correctness and robustness of the
package.
createRpactUnitTestResultDocumentation(packageProjectBaseDirectory,
ignoreFilesRegex = ignoreFilesRegex)Generate Performance Qualification Documentation
The createRpactPerformanceQualification function
generates documentation that outlines the performance qualifications of
the rpact package, ensuring it meets the required performance
standards.
createRpactPerformanceQualification(packageProjectBaseDirectory)By following these steps, the rpact package’s validation documentation is systematically generated and updated, ensuring accuracy, completeness, and compliance with validation standards.
Run the Interactive Validation Documentation SOP on the R Console
Validate the rpact package’s validation documentation using the
rpact.sops R package:
library(rpact.sops)
sopFile <- system.file("templates", "validation_documentation.json",
package = "rpact.sops")
if (!file.exists(sopFile)) {
sopFile <- file.path(getwd(), "inst", "templates",
"validation_documentation.json")
}
logEntries <- runSOP(sopFile = sopFile,
user = "Dr. Friedrich Pahlke",
pkg = "D:/R/workspace/rpact")
cat(paste0(logEntries, collapse = "\n"),"\n")The following log documents the process of updating and validating
the rpact package’s validation documentation using the
rpact.sops R package. The log captures each step involved
in ensuring that the validation documentation accurately reflects the
current version of the rpact package and its dependencies, as well as
any relevant changes in client information, R versions, and other
critical parameters.
Each entry in the log represents a specific task that was executed in the R console, facilitated by the rpact.sops package, which automates and guides the user through the necessary steps. These tasks include updating version numbers, modifying client-specific information, and verifying dependencies and performance qualifications.
After completing each task, the task is marked as “Approved” by the responsible person, confirming that the changes have been correctly implemented. The timestamps associated with each approval provide a chronological record of the validation process. This approach ensures traceability, compliance, and consistency in maintaining the rpact package’s validation documentation.
File rpact_software_validation_documentation.tex
SOP 1.1 Package Version Did you change the
definition of \newcommand{\fileName} in
rpact_software_validation_documentation.tex to version
4.2.0?
[OK] Approved by Dr. Friedrich Pahlke at July 30, 2025 CET 10:10:28
SOP 1.2 Package Version Did you change the
definition of \newcommand{\projectName} in
rpact_software_validation_documentation.tex to version
4.2.0?
[OK] Approved by Dr. Friedrich Pahlke at July 30, 2025 CET 10:10:29
SOP 1.3 Package Version Did you change the
definition of \newcommand{\rpactVersion} in
rpact_software_validation_documentation.tex to version
4.2.0?
[OK] Approved by Dr. Friedrich Pahlke at July 30, 2025 CET 10:10:31
SOP 1.4 R Version Did you change the definition of
\newcommand{\rVersionOldRelease} in
rpact_software_validation_documentation.tex to version
4.3.3?
[OK] Approved by Dr. Friedrich Pahlke at July 30, 2025 CET 10:10:32
SOP 1.5 R Version Did you change the definition of
\newcommand{\rVersionCurrentRelease} in
rpact_software_validation_documentation.tex to version
4.4.3?
[OK] Approved by Dr. Friedrich Pahlke at July 30, 2025 CET 10:10:33
SOP 1.6 Document Date Did you change the definition
of \newcommand{\copyrightYear} in
rpact_software_validation_documentation.tex to 2025?
[OK] Approved by Dr. Friedrich Pahlke at July 30, 2025 CET 10:10:34
SOP 1.7 Clients: Company Names Did you update the
definition of \newcommand{\docLicenseCompanyFullLength} in
rpact_software_validation_documentation.tex?
[OK] Approved by Dr. Friedrich Pahlke at July 30, 2025 CET 10:10:35
SOP 1.8 Clients: Company Names (short) Did you
update the definition of \newcommand{\docLicenseCompany} in
rpact_software_validation_documentation.tex?
[OK] Approved by Dr. Friedrich Pahlke at July 30, 2025 CET 10:10:36
SOP 1.9 Clients: Company Logos Did you update the
definition of \newcommand{\docLicenseCompanyLowerCase} in
rpact_software_validation_documentation.tex?
[OK] Approved by Dr. Friedrich Pahlke at July 30, 2025 CET 10:10:37
2 History of the Documents
SOP 2.1 URS Document History Did you update the table ‘History of the Document’ in rpact_user_requirements.tex?
[OK] Approved by Dr. Friedrich Pahlke at July 30, 2025 CET 10:10:19
SOP 2.2 FS Document History Did you update the table ‘History of the Document’ in rpact_functional_specification.tex?
[OK] Approved by Dr. Friedrich Pahlke at July 30, 2025 CET 10:10:39
SOP 2.3 SDS Document History Did you update the table ‘History of the Document’ in rpact_software_design_specification.tex?
[OK] Approved by Dr. Friedrich Pahlke at July 30, 2025 CET 10:10:41
SOP 2.4 Verification Document History Did you update the table ‘History of the Document’ in rpact_test.tex?
[OK] Approved by Dr. Friedrich Pahlke at July 30, 2025 CET 10:10:42
3 Chapter ‘’Test Protocol (TL)’’
SOP 3.1 ‘CRAN-Package-Check-Results.png’ Did you update the screenshot ‘CRAN-Package-Check-Results.png’ in folder ‘/4_verification/chapter/validation_results’?
[OK] Approved by Dr. Friedrich Pahlke at July 30, 2025 CET 10:10:43
SOP 3.2 ‘rpact-00check.txt’ (Linux) Did you update ‘rpact-00check.txt’ in folder ‘/4_verification/chapter/validation_results/win-builder_results/check_log_linux’? [OK] Approved by Dr. Friedrich Pahlke at July 30, 2025 CET 10:10:45
SOP 3.3 ‘rpact-00check.txt’ (Windows) Did you update ‘rpact-00check.txt’ in folder ‘/4_verification/chapter/validation_results/win-builder_results/check_log_windows’? [OK] Approved by Dr. Friedrich Pahlke at July 30, 2025 CET 10:10:46
SOP 3.4 Dependency Check Protocol Did you update the sections Depends, Imports, and Suggests in file ‘/4_verification/chapter/rpact_dependencies.tex’?
[OK] Approved by Dr. Friedrich Pahlke at July 30, 2025 CET 10:10:47
SOP 3.5 Chapter ‘Performance Qualifications (PQ)’ Are the information (OS, system type, processor, time table) in ‘/4_verification/chapter/rpact_test_protocol.tex’ plausible?
[OK] Approved by Dr. Friedrich Pahlke at July 30, 2025 CET 10:10:51
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 |
|---|---|---|