21 CFR Part 11 Compliant Chromatography Data System for GMP Pharmaceutical Laboratories
Product Overview
Our Chromatography Data System (CDS) is a serve r-based software platform that provides comprehensive instrument control, data acquisition, processing, and reporting for HPLC, UHPLC, and GC instruments across the entire lab. Designed for strict GMP environments, it includes full electronic signatures, immutable audit trails, role-based access control, and automated data backup. The CDS streamlines workflow from sample submission through final report generation, integrating directly with LIMS and ERP systems via REST API. Achieve paperless batch review and shorten your QC release cycle by 50%.
Cause
FDA warning letters increasingly cite data integrity failures: shared user accounts, deleted raw data files, unreported reinjections, and unprotected Excel spreadsheets used as “shadow CDS”. If your lab operates multiple instruments each with its own software, data review becomes fragmented and time-consuming. An investigator can easily find a mismatch between the instrument log and the final report. Without a secure, centralized CDS that enforces procedural controls, your lab risks 483 observations, dosage form recalls, and even application integrity actions that can halt new product approvals.
Solution
Our CDS centralizes all instruments onto a single SQL database, deployed on a Window s Serve r with active directory authentication. Every analyst logs in with a unique ID and password; roles define which methods they can run, modify, or approve. All raw data files, integration events, and method changes are recorded in a secure audit log that cannot be edited, even by administrators. The system enforces sequence execution exactly as defined; any manual run requires a documented reason. Processing methods are version-controlled. Reports are signed electronically following 21 CFR Part 11 requirements, and the system auto-locks data 30 days after approval to prevent retroactive changes.
Specifications
| Parameter |
Specification |
| Architecture |
Client/Serve r, Microsoft SQL Serve r |
| Instruments Controlled |
Up to 100 LC/GC per network |
| User Management |
Active Directory/LDAP integration |
| Electronic Signature |
Biometric or token-based, compliant 21 CFR Part 11 /EU Annex 11 |
| Audit Trail |
Immutable, searchable by date/user/action |
| Data Integrity |
MD5 checksums on all raw data files |
| Integration |
REST API, LIMS-connect module, ERP export |
| Report Templates |
Customizable layouts, PDF, Excel, secure e-signature |
| Backup |
Automated hourly incremental, daily full |
| Compliance |
FDA 21 CFR Part 11, EU GMP Annex 11, ISO/IEC 17025 |
Application
- QC batch release for dru g substances and products
- Stability testing data management
- Method validation and transfer between sites
- Contract research organizations (CRO) with multi-client separations
- Biologics characterization (peptide mapping, glycan analysis)
- Routine environmental monitoring LIMS integration.
How It Works
When an analyst logs in, the CDS client connects to the serve r, loading their allowed instruments and methods. After sample set creation, the sequence is submitted and locked. During the run, detector signals stream to the serve r in real-time, bypassing local storage. Post-run, the data is processed automatically with the assigned method, and results are populated into a review dashboard. A reviewer (second person) inspects each integration, compares with the system suitability criteria, and either approves or rejects with a comment. Approved results are pushed to LIMS automatically; all data files are checksummed and archived.
How To Choose
Assess the number of instruments and concurrent users: a single serve r handles up to 100 LC/GC, but you may need a redundant serve r for 24/7 operation. If you run multiple GMP sites, choose the global database version with centralized user management. For labs that generate 50+ sequences a day, the review-by-exception module flags OK results and speeds the review process. Our deployment team conducts a site validation workshop, mapping your workflows to the CDS, and provides a complete validation package including OQ scripts.
FAQ
Q1: Can legacy HPLC systems be controlled by this CDS?
A: Yes, via a universal instrument interface that provides ADC or digital communication. We can control HPLC systems up to 15 years old with full data auditability.
Q2: What happens if the serve r fails during a run?
A: Each instrument controller has local buffer memory that stores up to 24 hours of data. On serve r reconnection, data is automatically uploaded and consolidated.
Q3: How do you prevent unauthorized reprocessing?
A: Reprocessing requires a separate “Reprocess” privilege and is captured with a before/after overlay report in the audit trail, showing exactly what changed.
Q4: Is training provided for auditors?
A: Yes, we provide an auditor role and training module so your QA can view data and audit trails without any risk of modification. Guest auditor accounts can be issued for inspections.
