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.
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.”
Chromeleon CDS contains extensive audit trails that record the details used to generate a result.
|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|
|eBook||Delivering Data Security, Integrity, and Credibility: Your Reference Resource for Using a Modern Software System to Ensure Compliance||Compliance|
|Product Spotlight||Ensure Compliance||Compliance|
|Technical Note||Performing Automated System Suitability Testing and Intelligent Run Control||Compliance/Productivity|
|Technical Note||Intelligent Integration Using Cobra and SmartPeaks||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|
|Presentation Slides||Validation for Compliance and Data Integrity. Why do You Need it & How do You do it?||Compliance|
|Presentation Slides||Using Chromeleon 7.3 CDS to Comply with Regulations||Compliance|