Internal Audit and Compliance: Strengthening Regulatory Readiness
In today’s highly regulated industries, internal audit and compliance play a critical role in maintaining operational integrity and meeting legal obligations. Organizations operating under strict regulatory compliance requirements must ensure that their systems, processes, and documentation consistently align with applicable standards and laws.
21 CFR Part 11 Validation: Ensuring Compliance with FDA Regulations
In today’s regulated life sciences environment, 21 CFR Part 11 validation is critical for companies managing electronic records and electronic signatures. Under FDA 21 CFR Part 11, organizations must ensure that electronic systems are secure, reliable, and capable of maintaining data integrity in accordance with U.S. FDA regulations.
What Is an Investigational New Animal Drug (INAD)?
A Regulatory Pathway for Veterinary Drug Development
Veterinary medicinal products require rigorous testing to ensure that they are safe and effective for use in animals. In the United States, the development of new animal drugs is governed by the U.S. Food and Drug Administration (FDA) under the Center for Veterinary Medicine (CVM).
What Is Corrective Action and Preventive Action (CAPA)?
A Critical Quality Management Process in Life Sciences
Staying on top of regulatory standards is a must in pharmaceuticals, biotech, and medical devices. When quality issues pop up, companies turn to Corrective Action and Preventive Action better known as CAPA. It’s not just a checkbox, either. CAPA forms the foundation of quality management systems, and regulators everywhere expect to see it in action.
Clarification on the Use of the Sister File Procedure-EDQM
The current EDQM policy PA/PH/CEP (09) 141, 2R, “Guidance on applications for “sister files”, has guided the sister file procedure for CEPs for many years. Experience gathered over time indicates that there may be discrepancies in the understanding of the procedure and the EDQM has noted that certain CEP applications are being submitted under the sister file procedure even though their characteristics would more appropriately classify them as new applications.