Audit trails are an important regulatory requirement and are a proven effective means of detecting data integrity issues.
Chromatography Data System Compliance and Data Security
Make compliance a competitive advantage
With the ever-evolving emphasis on data integrity, data security and compliance, it’s of vital importance that your chromatography data system provides comprehensive preventative and detection technical controls to enable you to meet modern regulatory requirements including United State Federal Drug Administration (US FDA) 21 CFR Part 11 and European Commission (EU) Annex 11.
CDS compliance and data security featured resources
21 CFR Part 11 established requirements to ensure that electronic records are trustworthy, reliable and equivalent to paper records and handwritten signatures.
An increased focus on data integrity by international regulatory agencies has resulted in data integrity becoming one of the top reported global issues that regulated companies face.
“Chromeleon CDS has moved us away from the inefficient practices of transcribing data into a spreadsheet and helps us to address data integrity within the lab.”
“Chromeleon CDS has really improved our data integrity and ticks all of the boxes for compliance with 21 CFR Part 11 and the MHRA GMP data integrity definitions and guidance for industry.”