With the digital transformation of research laboratories, more pharmaceutical companies are choosing to use electronic records instead of paper-based documentation. The 21 CFR Part 11 regulations, issued by the U.S. Food and Drug Administration (FDA), outline how pharma companies must set up and maintain electronic records, including electronic signatures. The “predicate rules” in U.S. GxP regulations outline which records are subject to 21 CFR Part 11.
If pharma companies do not comply with 21 CFR Part 11, they can face significant penalties including import bans and a delay in new product approvals. Most companies are well aware of the consequences of not complying with Part 11. However, it is not a straightforward process to reconfigure legacy systems so they comply with these regulations.
While regulatory compliance is the responsibility of each pharma company, electronic systems, such as LabTwin’s voice-activated digital lab assistant, can support this process. Our digital lab assistant can integrate with legacy systems to help streamline 21 CFR Part 11 compliance.
The LabTwin company has ISO/IEC 27001:2017 and ISO/IEC 27017:2015 certification, confirming our compliance with international gold standards for information security. LabTwin protects digital data through controlled user access, data encryption and private networks.
Our system leverages voice-recognition technology to store unalterable original versions for all voice documents. This is a new technology that allows scientists to make truly contemporaneous, original, time stamped data records at the point of experimentation. Our digital lab assistant also tracks and records which users access each electronic document and monitors all changes to every text document – features which make it easy to find altered or invalid records.
Pharmaceutical companies can use LabTwin’s unique capabilities as part of an overall strategy to improve 21 CFR Part 11 compliance and manage electronic documentation.