validate-piles-notation

Validate statistical analysis output through double programming, independent verification, and reference comparison. Covers comparison methodology, tolerance definitions, and deviation handling for regulated environments. Use when validating primary or secondary endpoint analyses for regulatory submissions, performing double programming (R vs SAS or independent R implementations), verifying that analysis code produces correct results, or re-validating after code or environment changes.

Check BibTeX entries for completeness, DOI resolution, and broken links. Verify required fields per entry type (article, book, inproceedings), resolve and validate DOIs via the CrossRef API, check URL accessibility, and flag duplicate entries, missing abstracts, and inconsistent formatting. Use when preparing a manuscript bibliography for journal submission, auditing a shared .bib file before a project milestone, after merging bibliographies from multiple sources, when citations render incorrectly, or as a CI check on version-controlled .bib files.

Validate a chromatographic analytical method per ICH Q2(R2) guidelines: define the validation scope by method category, establish specificity through forced degradation, determine linearity and range, assess accuracy and precision, and establish detection limits and robustness for regulatory submission.

Decommission a validated computerized system at end-of-life. Covers data retention assessment by regulation, data migration validation (mapping, transformation, reconciliation), archival strategy, access revocation, documentation archival, and stakeholder notification. Use when a validated system is being replaced, reaching end-of-life without replacement, vendor support is discontinued, multiple systems are consolidating, or regulatory changes render a system obsolete.

One to three sentences describing what this skill accomplishes, followed by key activation triggers. This field is the primary mechanism agents use to decide whether to activate the skill — it is read during discovery before the full body is loaded. Start with a verb. Include the most important "when to use" conditions inline. Max 1024 characters.

Create R package vignettes using R Markdown or Quarto. Covers vignette setup, YAML configuration, code chunk options, building and testing, and CRAN requirements for vignettes. Use when adding a Getting Started tutorial, documenting complex workflows spanning multiple functions, creating domain-specific guides, or when CRAN submission requires user-facing documentation beyond function help pages.

Write IQ/OQ/PQ validation documentation for computerized systems in regulated environments. Covers protocols, reports, test scripts, deviation handling, and approval workflows. Use when validating R or other software for regulated use, preparing for a regulatory audit, documenting qualification of computing environments, or creating and updating validation protocols and reports for new or re-qualified systems.

Write comprehensive testthat (edition 3) tests for R package functions. Covers test organization, expectations, fixtures, mocking, snapshot tests, parameterized tests, and achieving high coverage. Use when adding tests for new package functions, increasing test coverage for existing code, writing regression tests for bug fixes, or setting up test infrastructure for a package that lacks it.

Write a GxP-compliant Standard Operating Procedure (SOP). Covers regulatory SOP template structure (purpose, scope, definitions, responsibilities, procedure, references, revision history), approval workflow design, periodic review scheduling, and operational procedures for system use. Use when a new validated system requires operational procedures, when existing informal procedures need formalisation, when an audit finding cites missing procedures, when a change control triggers SOP updates, or when periodic review identifies outdated procedural content.

Write roxygen2 documentation for R package functions, datasets, and classes. Covers all standard tags, cross-references, examples, and generating NAMESPACE entries. Follows tidyverse documentation style. Use when adding documentation to new exported functions, documenting internal helpers or datasets, documenting S3/S4/R6 classes and methods, or fixing documentation-related R CMD check notes.

Create structured incident runbooks with diagnostic steps, resolution procedures, escalation paths, and communication templates for effective incident response. Use when documenting response procedures for recurring alerts, standardizing incident response across an on-call rotation, reducing MTTR with clear diagnostic steps, creating training materials for new team members, or linking alert annotations directly to resolution procedures.

Create production-ready Helm charts for Kubernetes application deployment with templating, values management, chart dependencies, hooks, and testing. Covers chart structure, Go template syntax, values.yaml design, chart repositories, versioning, and best practices for maintainable and reusable charts. Use when packaging a Kubernetes application for repeatable deployments, parameterizing manifests for multiple environments, managing complex multi-component applications with dependencies, or standardizing deployment practices with versioned rollback capability across teams.