Essential Components of Data Governance – Part 1
While there is no one size fits all data governance prescriptive plan, at ResultWorks, an Astrix Business, we believe there are principles and themes that are essential to any data governance program’s success. These are two of the essential principles. Clearly Understand the Challenges at Hand In order to effectively address data quality and governance […]
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 […]
Data Integrity for Scientific Data in Flight
Ensuring data integrity is an essential component of the biopharmaceutical industry’s responsibility to guarantee the safety, efficacy, and quality of therapeutics, and of FDA’s ability to protect public health. The FDA defines data integrity as the completeness, consistency, and accuracy of data. “Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or […]
Addressing Data Management Challenges in Genomics Research
With the successful completion of the Human Genome Project on April 14, 2003, the mapping of the human genome took approximately 13 years and 3 billion dollars to accomplish. Today, next-generation sequencing (NGS) technology allows a human genome to be sequenced in just a few days for a few hundred dollars. With ultra-high throughput, speed […]
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 […]