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.

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21 CFR Part 11 established requirements to ensure that electronic records are trustworthy, reliable and equivalent to paper records and handwritten signatures.

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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.

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“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.”

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With Chromeleon CDS you can satisfy regulatory requirements without sacrificing efficiency using the integrated security system, audit trails, and version management tools.

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“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.”

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Ensuring Data Integrity using Enterprise Software
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.

Part 1: Audit Trails  |  Part 2: Data Security


CDS compliance and data security videos


CDS compliance and data security resources

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Type Title Category
Case Study Broughton Laboratories – A global analytical GMP business perspective Compliance/Productivity
Case Study Chromeleon CDS delivers efficiency gains and compliance and data integrity improvements to UK CRO/CMO Compliance
Case Study Sigma-Aldrich CMO helps customers comply with 21 CFR Part 11 using Chromeleon CDS software Compliance
Customer Collaboration Article Sterling Biostrata article Compliance
Product Spotlight Ensure Compliance Compliance
Technical Note Automate System Suitability Testing with Chromatography Software Compliance/Productivity
Technical Note Intelligent Integration Using Cobra and SmartPeaks Productivity
Video Compliance/Productivity
Webinar Achieving and Demonstrating Compliance and Data Integrity with Your CDS: Sterling Pharma Solutions Ltd Compliance
Webinar Comply with Data Integrity Regulations with Chromeleon CDS Software Compliance
Webinar Comply with Data Integrity Regulations with Chromeleon CDS Software (Italian) Compliance
Webinar Integrated Informatics for Data Integrity: Part 1 Compliance
Webinar Integrated Informatics for Data Integrity: Part 2 Compliance
Webinar The Use of eWorkflows and Templates to Improve Efficiency and Compliance: Broughton Laboratories Compliance/Productivity
White Paper Data integrity: Audit Trails with Ease of Review Compliance
White Paper Data Integrity: Technical controls that demonstrate trust Compliance
White Paper Using Chromeleon 7 Chromatography Data System to Comply with 21 CFR Part 11 Compliance