Electronic Records versus Paper Records
CFR 21 Part 11 regulates the acceptance criteria for electronic documents created mostly by electronic systems as software. Since analysis processes and data created by LabImage Platform is no longer paper based, electronic records needs to be considered equivalent to paper based records and handwritten signatures. For the first time, this determines how paperless record systems can be compliant with most GLP, GMP and GCP processes – we call GxP environments.
The 21 CFR Part 11 rules establish minimum criteria for electronic records and electronic signatures to be trustworthy and reliable. The intention is to minimize opportunities for record falsification and to maximize chances of detecting falsifications.
The use of electronic records and electronic signatures is still voluntary but most companies consider this as essential part of any IT based analysis system. Companies can decide to replace their paper based record-keeping with electronic record-keeping processes.
See the video of how to install and setup LabImage 1D with full 21 CFR Part 11 compliance.