Chromperfect CFR 21 Part 11 Database (CPDB)
Secure, Searchable Archiving for Full Regulatory Compliance
CPDB is Chromperfect's intelligent data archival solution, purpose-built to meet the strict requirements of FDA 21 CFR Part 11. Whether you’re operating in a regulated pharmaceutical lab or simply want bulletproof data traceability, CPDB ensures your Chromperfect files are securely captured, indexed, and version-controlled.
Full Automation from File to Database
CPDB works behind the scenes to automatically import Chromperfect files — including Bound Data, Calibration, Method, and Sequence files — into a secure, structured database. Whether installed as a background service or run interactively, CPDB ensures no file goes untracked.
Key Benefits:
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Real-Time File Monitoring: Automatically watches specified folders and imports new files.
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Version Tracking & Audit Trails: Every file version is logged with reason-for-change and timestamp.
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Multi-File Support: Handles Raw, Bound, Method, Calibration, and more.
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Component-Level Data Capture: Stores rich chromatographic metadata from Bound files.
Open or Restricted Modes – You Choose the Control Level
CPDB is fully adaptable to your compliance environment:
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Open Mode: Easy extraction and editing — ideal for research or development environments.
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Restricted Mode: Enforces rigorous controls over file handling and saving — designed for CFR 21 Part 11 environments where strict auditability is required
Complete Control with Powerful Tools
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CPDB Reader: Browse and extract stored files, filter by date or approval status.
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CPDB Sentry / Service: Choose between desktop or background operation for file monitoring and import.
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CPDB Monitor & Tattletale: Real-time feedback on file imports and service status.
Customizable & Scalable
Need to track additional file types or add your own fields? CPDB is designed to grow with your lab:
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Customize database tables and columns
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Use ANYCP mode to catch all Chromperfect-supported file types
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Create tailored watchers for multiple instruments or departments
Easy Installation, Enterprise-Ready
CPDB is plug-and-play with Chromperfect Version 10 and works with Microsoft Access or enterprise-grade databases. Built-in registry options and configuration tools make setup simple for IT teams and lab managers alike.
Built for Compliance. Designed for Performance.
When file integrity, auditability, and traceability matter — CPDB delivers. Fully compatible with Chromperfect 10, CPDB offers a seamless pathway to regulatory-grade data management without compromising usability.
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