What is an Investigator’s Brochure (IB)?
Clinical trials are the foundation of pharmaceutical innovation, and their success depends on clear communication between sponsors and investigators. The Investigator’s Brochure (IB) is a critical document that provides comprehensive information about an investigational product, ensuring that clinical trial teams understand its properties, risks, and potential benefits. It serves as both a scientific reference and a regulatory requirement.
What is CAPA (Corrective and Preventive Action)?
In the pharmaceutical industry, maintaining product quality and patient safety requires robust systems to identify and resolve issues. Corrective and Preventive Action (CAPA) is a cornerstone of quality management, designed to address problems, prevent recurrence, and ensure compliance with global regulatory standards.
Overview of Computer System Validation (CSV)
In the pharmaceutical and life-sciences sector, computerized systems play a central role in manufacturing, laboratory analysis, quality management, and regulatory documentation. To ensure these systems function consistently and comply with global health authority expectations, companies implement Computer System Validation (CSV).
What is Document Management System (DMS)?
In the pharmaceutical industry, documentation is the backbone of compliance, quality assurance, and regulatory approval. Every stage of drug development—from research to manufacturing—requires meticulous records.
What is a Quality Risk Assessment?
Quality Risk Assessment (QRA) is a cornerstone of modern pharmaceutical quality systems. In an industry where patient safety, regulatory compliance, and product integrity are non-negotiable, QRA provides a structured way to evaluate potential risks and implement controls before issues can affect product quality.