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What is the rpact Software Validation Documentation?

Overview

The “rpact Software Validation Documentation” is a comprehensive resource designed to ensure the formal validation of the R package rpact, specifically for use in GxP-regulated environments such as the pharmaceutical industry. This document provides the necessary evidence to satisfy rigorous audit and compliance requirements, enabling organizations to demonstrate that the software functions reliably and as intended.

Purpose

1. Formal Validation Evidence: The documentation confirms that rpact meets user and functional requirements, adhering to industry standards.
2. Audit Preparedness: It provides detailed information that auditors can review during compliance checks, reducing the burden on internal teams.
3. Regulatory Compliance: The document supports compliance with relevant regulations, including FDA and EMA guidelines, which are crucial for GxP environments.

Key Features of the Documentation

The validation documentation includes the following key sections:

• User Requirements Specification (URS): Outlines the purpose, scope, and applicable regulatory concerns.
• Functional Specification (FS): Details the functionalities of rpact, including trial designs, simulation tools, and analysis capabilities.
• Software Design Specification (SDS): Explains the architectural principles, clean code practices, and package structure.
• Verification: Contains the test plan, including installation checks, function testing, and unit test results.

Why is This Important for GxP Compliance?

In GxP-regulated environments, software validation is not optional. It ensures:

• Data Integrity: Accurate and reliable results from statistical analyses.
• Risk Mitigation: Identification and resolution of potential software issues before they impact critical processes.
• Regulatory Approval: Smooth submission processes for clinical trials and other regulated activities.

Exclusivity

The “rpact Software Validation Documentation” is exclusively available to paying customers. Each document is uniquely rendered with customer-specific licensing details, such as:

• Company Name
• Company Logo
• Unique Licensing Information

This personalized approach not only enhances security but also ensures that the documentation aligns with the customer’s specific requirements and compliance framework.

Why You Should Consider It

If you are not yet a customer, consider the following:

• Stay Audit-Ready: Avoid last-minute rushes to compile validation evidence during audits.
• Build Confidence: Demonstrate to stakeholders that your processes leverage rigorously validated tools.
• Join the Community: By becoming a paying customer, you gain access to a network of industry leaders prioritizing Open Source solutions for regulated environments.

To learn more about acquiring the “rpact Software Validation Documentation” or to request a demo of its capabilities, contact us at info@rpact.com.