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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
Audit trails are an important regulatory requirement and are a proven effective means of detecting data integrity issues.
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.”
With Chromeleon CDS you can satisfy regulatory requirements without sacrificing efficiency using the integrated security system, audit trails, and version management tools.
“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.”
Ensuring Data Integrity Using Enterprise Software
Having an integrated enterprise software solution: Discover the key features of a combined CDS, LIMS and SDMS that help you ensure data integrity and compliance for your laboratory.
Using Versioning to Understand the History of Data
Chromeleon CDS contains extensive audit trails that record the details used to generate a result.
CDS compliance and data security videos
CDS compliance and data security resources
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