In GxP environments, such as pharmaceuticals, biotech, and food industries, strict regulatory compliance and data integrity make robust data architecture essential. Here we delve into: effective folder structures, permission management, and user account controls are critical to ensuring security and compliance. Using Active Directory (AD) groups over individual access levels …
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 …