Quality agreements are vital documents that outline the roles, responsibilities, and expectations between a company and its suppliers. For pharmaceutical companies, ensuring quality throughout the supply chain is crucial for compliance with regulatory requirements and maintaining product integrity. Here are key considerations to include in a quality agreement for suppliers. …
In the pharmaceutical industry, ensuring the quality, reliability, and compliance of computer systems is critical. This is where Computer System Validation (CSV) plays a pivotal role. However, while CSV itself is a structured approach to ensuring systems perform their intended functions, it is the Quality Assurance (QA) team that ensures …
The User Requirements Specification (URS) is a critical document in the Computer System Validation (CSV) lifecycle. A URS defines what a computerized system must achieve to support business-critical functions and comply with regulatory standards. This blog explores the essentials of developing a URS, highlighting its purpose, key components, and best …