In the Zone: data management
Data management is a common terminology used in almost all industries. It comprises all disciplines related to managing data as a valuable resource. Regulated bioanalytical laboratories generate enormous amounts of data for regulatory submission and approval. Paper-based or hybrid lifecycle data management in the bioanalytical laboratories is common even though it has been recognized as inefficient and includes potential compliance risks in the drug development process. The purpose of data management is to ensure the entire data lifecycle is under stringent control, so that we can achieve the goal of generating data with highest quality and accountability, as well as protecting data with highest integrity and security.
To achieve this goal, efforts need to be put into every steps of data flow, including data generation, capture, processing/analysis, resulting, transfer/sharing, storage/backup/recovery, quality control (QC)/quality assurance (QA) and compliance with regulatory rules and guidelines. To sum it up, data quality/accountability, integrity and security are the cores of data management in the bioanalytical world. That all being said, as long as we stick to the essential rules of safeguarding data in its entire lifecycle, it is not hard to know what to do in the day-to-day practice of managing data in the bioanalytical industry. We are presenting to you here, how Frontage, as a global leading bioanalytical CRO, take data management seriously and strive to keep up with the highest standards in the industry.
Top tips on data management – This infographic explores five top tips for ensuring data quality. These include top tips on; how to ensure high quality accountability data, how to ensure data security, details on ALCOA, details on 21 CFR part 11 and the importance of GDPR.
The importance of data management: an interview with Xiaonan Tang – In this podcast, Xiaonan Tang (Senior Director at Frontage, PA, USA) discusses the importance of data management. Data management is a common term used in almost all industries and it comprises all disciplines related to managing data as a valuable resource. Xiaonan explains how Frontage take data management seriously and strive to keep up with the highest industry standards.