FDA 21 CFR Part 11 Requirements for NIR Spectroscopy

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…

W H I T E PA P E R VISION SP: Security Pack for 21 CFR Part 11 compliance Introduction  Wyatt Technology’s VISION Security Pack (SP) product provides multiple features to address those aspects of regulatory compliance that are…

[ 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…

[ WHITE PAPER ] The Role of UNIFI Scientific Information System in Assisting with Electronic Records Regulation Compliance INTRODUCTION The objective of this white paper is to discuss the electronic record and Data Integrity compliance readiness of Waters™ UNIFI™ Scientific…