Data Integrity and Compliance: What Every Lab Should Know | Advanced instruments
We are open and continue to provide essential lab supplies during the COVID-19 pandemic. Answers to your FAQs can be found here. Read More
Bioprocessing
ENDEFR

Data Integrity and Compliance: What Every Lab Should Know

Data Integrity and Compliance: What Every Lab Should Know

In 2017, data integrity issues were cited in 65% of all FDA warning letters. The main reason was incomplete data. In the pharmaceutical and biotechnology industries, this can be prevented by ensuring the trustworthiness and reliability of electronic records, a process that is also known as compliance with data integrity. The highest risks, when not working in a compliant manner, lie in import bans, product recalls, or even the closing of production plants. The FDA defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records in Title 21 of the Code of Federal Regulations (21 CFR) Part 11.

Download App Note

Bioprocessing
ENDEFR

Data Integrity and Compliance: What Every Lab Should Know

Please fill out this brief form to download this content.