What the FDA Guidance on Data Integrity Means for Your Lab
Regulatory agencies worldwide are increasingly focusing their efforts on data integrity in GxP laboratories. This increased focus has led to a number of guidance documents being published on data integrity in 2016, including: The World Health Organization (WHO) published its final version of “Good Data and Records Management Practices” guidance document The European Medicines Agency […]
10 Ways to Ensure Data Integrity
Data Integrity can be expressed as the consistency and trustworthiness of data over the course of its lifecycle. The status of your data, or the process of guaranteeing the quality and validity 1 – Standard Data Definitions Need to have a single definition of all data types across the organization. Data being reported across the […]
Trends in FDA Data Integrity 483s and Warning Letters for Pharmaceutical Companies
The manufacture of pharmaceutical drugs is a highly complex process that involves advanced scientific analysis and instrumentation at all stages of production and storage. In order to guarantee the safety and efficacy of both human and veterinary drugs, the FDA strives to verify data integrity in all cGMP records used to document and guide the […]
Enhancing Data Integrity in Clinical Research with Blockchain Technology
Verification of data integrity is a critical part of the FDA’s mission to ensure the safety, efficacy and quality of human and veterinary drugs, biological products, and medical devices. As these products must undergo extensive testing before being approved for the public, gathering high-quality, reliable and statistically sound data is an important goal for all […]
Data Integrity: The Importance of a Quality Culture
Verification of data integrity is a critical part of the FDA’s mission to ensure the safety, efficacy and quality of human and veterinary drugs, biological products, and medical devices. As such, the FDA’s expectation is that all data generated to support the quality of manufactured products is both reliable and accurate. Compliance violations involving data […]