Article | September 1, 2021

Data Integrity And Data Access Control For Filter Integrity Test Instruments

Source: Cytiva

By Razan Jammal, Global Product Manager Instrumentation, Pall Corporation

science formula data iStock-1047349788

The most recent guidance documents from the US Food and Drug Administration (FDA) and the British Medicines & Healthcare Products Regulatory Agency (MHRA) regarding the data integrity of electronic records were issued in 2018. Other agencies like the European Medicine Agency (EMA) issued similar guidelines. The National Institute of Standards and Technology, meanwhile, published updated digital identification guidelines in 2017.

The FDA document on ‘data integrity and compliance with drug cGMP’ is in question-and-answer format designed to clarify the role of data integrity in current good manufacturing practice (cGMP) for drugs as required in 21 CFR Parts 210, 211, and 212. This document was issued because the agency was finding noncompliance at many pharma companies, including large, established firms.

Despite the guidance the FDA continues to uncover data integrity compliance problems, as reflected by the number of warning letters issued in the last two years. Clearly many drug manufacturers - and potentially equipment vendors - remain not fully aware of the regulatory requirements around electronic records and signatures.

Assuring the integrity of records when generating and maintaining them is essential to the development and production of high-quality, safe, and effective drugs and as digital technologies have advanced, regulatory requirements regarding data integrity have also evolved.


Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Cell & Gene? Subscribe today.

Subscribe to Cell & Gene X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.


Subscribe to Cell & Gene