Data Integrity in FDA-Regulated Laboratories
In 2018 the FDA issues updated guidance for data integrity. The Food and Drug Administration (FDA or Agency) released the availability of a final guidance for industry entitled “Data Integrity and Compliance With Drug CGMP. This white paper explores this topic in depth relative to how it’s applied to regulated laboratories.
Data Integrity in FDA-Regulated Laboratories
About the eBook
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 which is submitted to the Agency is both reliable and accurate.
In this informative eBook, Astrix will detail the key issues, expectations and potential pitfalls as it relates to achieving a high degree of data integrity relative to the FDA guidance.
Enforcement actions by the FDA with respect to data integrity-related cGMP violations can result in serious financial consequences for an organization due to facility shutdown, product recalls, import and/or distribution bans, delayed or denied drug approvals, substantial remediation costs, and loss of customers due to a damaged reputation.
This eBook will provide commonsense guidance and advice on how to create a data integrity along with key references from the FDA on how to structure a successful program.
About Astrix
Astrix Technology Group provides complete LIMS implementation services and laboratory software development services as part of our complete laboratory technology professional services offering. Clients are increasingly seeking a strategic IT partner rather than an IT vendor who can not only understand their challenging problems, but also solve them by taking complete ownership during requirement, design, implementation, testing and go-live phases of SDLC.
Astrix is a leader in the field of scientific informatics and laboratory operations and has successfully demonstrated the use of industry wide best practices in the evaluation of work processes, functional and technical requirements, laboratory processes and informatics solution options. Our innovative solutions allow organizations to deploy systems that turn data into knowledge, increase organizational efficiency, improve quality and facilitate regulatory compliance. We have a group of professionals that are dedicated to the laboratory industry that bring together technical, strategic and content knowledge that enables our organization to provide the most effective solutions to problems faced by scientific organizations. We also offer complete nearshoring options to support competitive pricing strategies for all our services.