Learn the fundamental steps and best practices for successful Process Validation in manufacturing, covering design, qualification, and continuous monitoring to ensure product quality and compliance.
Navigating IT change management within the regulated pharmaceutical sector involves a meticulous approach to ensure compliance, data integrity, and system effectiveness. This blog explores steps, key strategies, challenges and best practices to master this complex process.
In the pharmaceutical industry, ensuring product quality is paramount. Rigorous environmental monitoring plays a critical role in maintaining this quality by preventing contamination and achieving regulatory compliance. This blog explores how environmental monitoring improves pharmaceutical product quality, with practical insights.
21 CFR 211 compliance is your organization’s stepping stone to meeting the FDA’s definition of current good manufacturing practice (cGMP). Complying with 21 CFR 211 proves that your business has a safe, effective, consistent and quality-managed drug manufacturing operation in place.
Computer Systems Validation (CSV) – is a process used to test, validate and formally document that a regulated computer-based system does exactly what it is designed to do in a consistent and accurate manner that is secure, reliable and traceable.
