The role of sampling and measurement uncertainty in assessing production process capability is examined, using content uniformity testing as an example.
Electronic data and computerized systems introduce new challenges to maintaining data integrity. With increased scrutiny from regulatory authorities, companies need to have a thorough understanding of their regulated systems.
With IVT Network's 3rd Annual Data Integrity Validation event on the horizon we reached out to our speakers, Cathlin Shapiro of Bristol-Myers Squibb and Edward Eirikis of Janssen BioTherapeutics for their input on top data integrity issues.
Join IVT Network's Data Integrity Working Group! Led by Chris Wubbolt of QACV Consulting, LLC, join this founding work group to collaborate on an upcoming Data Integrity Handbook.
In March 2015, the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) published “GMP Data Integrity Definitions and Guidance.” This document outlines the definitions, principles, requirements, and approaches that MHRA considers appropriate aspects of data integrity.
The responsibility for knowing where your data are at all times and whether they are accurate and reliable is paramount for being compliant. How does your company address data integrity and are you ready to comply with the new FDA Guidance?
E-records integrity is a critical aspect to be well-thought-out during the design, implementation and usage of any system which stores, processes, or retrieves e-records.
With six guidance documents issued since January 2015 and a stream of FDA warning letters on the topic, Data Integrity has assumed proportions the likes of which have not been see in the pharmaceutical industry in the course Ginsbury's 30 year career.