Blog

1. Introduction Data integrity and compliance are critical components in electronic system audits, particularly in regulated industries like pharmaceuticals, healthcare, finance, and manufacturing. The integrity of data ensures that the information stored, processed, and retrieved by electronic systems remains accurate, consistent, and reliable. Compliance, on the other hand, focuses on adhering to relevant regulatory and…
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How do GCP auditors handle Risk Management Plans (RMPs)? Risk Management Plans (RMP) are strategic documents designed to identify, assess and mitigate risks associated with a project, product or activity.  In pharmaceuticals and healthcare, companies develop RMPs to manage medication risks, ensuring patient safety and regulatory compliance. In Good Clinical Practice (GCP) audits, auditors evaluate…
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In auditing GCP clinical trials, how do auditors ensure compliance in decentralized trials, including patient safety, privacy, and data integrity concerns in remote settings? GCP (Good Clinical Practice) auditors ensure compliance in decentralized trials.   This includes patient safety, privacy, and data integrity.  Through a combination of comprehensive audit processes, technologies, and regulatory frameworks, auditors follow…
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What are the latest developments at the FDA in risk-based quality management of GCP audits? The U.S. Food and Drug Administration (FDA) has been continuously advancing its approach to Good Clinical Practice (GCP) audits by emphasizing risk-based quality management.  This strategy focuses on identifying and managing potential risks to patient safety and data integrity throughout…
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