Select Page
nonconforming materials report

ALCOA: A Data Integrity Standard

For many years, data integrity has been of particular concern to both industry and global regulatory authorities. Data integrity requirements have increased, especially with the advent of new technologies and their need for rapid application to support development of new drugs and vaccines, manufacturing operations, and beyond. This rapid inclusion in the industry has resulted in an increase in data integrity observations issued from different regulatory bodies, resulting in warning letters and ending in legal investigations. The purpose of this White Paper is to discuss ALCOA as a methodology to implement data integrity processes in support of product quality and safety, as well as to avoid observation issuance from regulatory authorities.

Download your FREE White Paper!


* These fields are required.

FOLLOW PATHWISE!

CHECK OUT OTHER PATHWISE WHITE PAPERS!

Key Performance Indicators for Life Science

Key Performance Indicators for Life Science The number of possible KPIs is endless. It all depends...

Free Download! Top 483 Observations from 2022

Top FDA 483 Warning Letter Observations from 2019 for Medical Device, Drugs, and Biologics Every...

Free Webinars

 FREE WEBINARS! PathWise has offered FREE webinars throughout the year. For the next three weeks,...

WHITE PAPER: 21 CFR 820 and ISO 13485:2016 Harmonization, Getting Ready for the QMSR​

21 CFR 820 and ISO 13485:2016 Harmonization: Getting Ready for the QMSR​ The purpose of this...