Compliance Group

Data integrity is a critical aspect of regulatory compliance in the pharmaceutical and medical device industries, overseen by agencies such as the U.S. Food and Drug Administration (FDA). Ensuring data integrity involves maintaining the accuracy, consistency, and reliability of data throughout its lifecycle. The FDA places significant emphasis on data integrity to ensure the safety, efficacy, and quality of products regulated by the agency. Here are key considerations related to FDA data integrity requirements:   1. ALCOA+ Principles:     - The FDA follows the ALCOA+ principles for data integrity, which stands for Attributable, Legible, Contemporaneous, Original, Accurate, and Complete. Data must meet these criteria to be considered reliable and compliant. 2. GxP Regulations:     - Data integrity requirements apply to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP), among others. Organizati...

  An ISO 9001 compliance checklist is a valuable tool for organizations seeking to ensure that their quality management system (QMS) aligns with the requirements of ISO 9001 standard. ISO 9001 is an internationally recognized quality management standard that sets out criteria for a QMS. Here is a checklist that covers key aspects of ISO 9001 compliance:  1. Quality Policy and Objectives:     - Has the organization established and documented a quality policy that is communicated and understood at all levels?    - Are measurable quality objectives in place, aligned with the quality policy, and reviewed regularly for effectiveness? 2. Leadership and Commitment:     - Is top management actively involved in promoting the QMS and demonstrating leadership and commitment?    - Are roles, responsibilities, and authorities defined and communicated within the organization? 3. Customer Focus:     - Is there a...