Pharma & Biotech: How Labs Achieve Data Integrity

Lack of data integrity can be a key reason for breaching compliance in the Pharma and Biotech industries. US and EU regulatory authorities have defined the criteria for ensuring trustworthy and reliable electronic records in computerized systems via a process known as compliance with data integrity. Regulations and standards such as 21 CFR Part 11, EudraLex Vol 4. Annex 11, GMP, and ISO 17025 establish controls for the use of electronic data systems, with the goal of reducing errors, simplifying processes and reinforcing compliance. The highest risks when not working in a compliant manner lie in import bans, product recalls or even the closure of production plants.

Shweta Nair, Sr. Product Manager – Biotechnology at Advanced Instruments, explains how important it is for companies to be compliant with data integrity and to ensure the trustworthiness and reliability of electronic records.