Lunatic hooks micro-volume biologics quantification up with compliant features

Technical Note Uncle suits up with compliant features Introduction For GxP labs, maintaining proper electronic records and data security is a must. Uncle has you covered with a 21 CFR Part 11 software tools, providing full sample tracking, data authenticity,…

Metrohm White Paper FDA 21 CFR Part 11 Compliance by Metrohm Raman Norms and Standards 21 CFR Part 11 is the FDA rule relating to the use of electronic records and electronic signatures. Recognizing the increasing impact of electronic media…

[ WHITE PAPER ] The Role of Empower Chromatography Data System in Assisting with Electronic Records Regulation Compliance INTRODUCTION The objective of this white paper is to discuss the 21 CFR Part 111 and EU EudraLex Annex 112 compliance readiness…

MicroLab FTIR Software 21 CFR Part 11 Compliance Technical Overview Introduction Electronic data submitted to the United States FDA must comply with specifications set forth in the Code of Federal Regulations, Title 21 Part 11 (21 CFR Part 11). This…