Digitally transform your chromatography workflows and eliminate the need for cumbersome paper or Excel-based logbooks.
A single audit request recently required one top-100 biopharmaceutical company to spend 80 hours manually compiling column usage data from traditional logbooks—data that could have been generated in minutes with modern tech. This scenario isn't uncommon. Another leading biopharma organization spends over 5,000 hours annually maintaining column documentation using paper-based and Excel workflows.
Managing chromatography data across multiple systems remains one of the biggest operational challenges in analytical labs. Scientists routinely have to work with data from Waters Empower, Thermo Scientific Chromeleon, Agilent OpenLab CDS, and Shimadzu LabSolutions, but extracting insights across these chromatography data systems (CDSs) typically requires manual data compilation and Excel workarounds.
The Chromatography Insights Solution
Clearing this massive bottleneck is why TetraScience introduced the Chromatography Insights app late last year. Chromatography Insights addresses the siloed data challenge by harmonizing CDS data into a unified analytics platform that provides enterprise-wide visibility into chromatography operations. Since its launch, the application has helped analytical teams streamline everything from method performance monitoring to instrument use across labs and sites.
Building on this success, we’ve now added automated column usage and logbook reporting to Chromatography Insights. Released in Q2 2025 and expanded in v1.5 with custom field search capabilities, these new features address one of the most time-intensive administrative tasks that analytical teams face: maintaining comprehensive column documentation for regulatory compliance.
The Column Logbook Challenge
Column logbooks provide comprehensive readouts of column lifetime usage, including every project, sample, method, and injection. While not explicitly mandated, these records are essential for demonstrating Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) under regulations such as the FDA's 21 CFR Part 211 and the EU GMP Annex 11. They provide traceability that inspectors expect and help labs monitor column performance over time.
The manual burden is staggering: Teams spend hours each month updating spreadsheets, hunting through filing systems for paper logbooks, and compiling scattered records when auditors request complete usage histories. Our customer research reveals:
- 5,000+ hours annually spent on manual column documentation at large biopharma organizations
- 80 hours required to prepare a single injection report during audits
- 40+ hours monthly for a typical column logbook utilization across lab operations
How We Got Here
Logbooks have existed for centuries, but specialized column logbooks emerged in the 1970s as a direct response to widespread chromatography data system (CDS) adoption. These platforms significantly increased lab throughput and testing capabilities, but traditional lab notebooks lacked the structured format necessary to efficiently track chromatography run details, such as total column injection usage.
The standardisation of column logbooks accelerated following the FDA's 1993 guidance on laboratory inspections. The new structured approach enabled clear tracking of key performance metrics and quick overviews of column health and usage. Column manufacturers soon adopted similar tracking within their production processes, enhancing column performance and traceability.
The widespread adoption of column logbooks in regulated industries, often spurred by high-profile GxP issues such as those highlighted in the Hazleton Laboratories scandal, served as a crucial step toward improving data integrity and traceability. However, their initial implementation as handwritten records introduced practical challenges: time-consuming processes, significant physical storage requirements, and daily retrieval from large cupboards or Kardex systems. Even today, many standard operating procedures (SOPs) continue to recommend the use of Excel- or paper-based logbooks, such as the example below provided by Pharmaguidehub.com for GC and HPLC column maintenance.
The most significant limitation of this traditional approach lies in the difficulty of manipulating handwritten data. When confronted with the vast volume of data generated in pharmaceutical laboratories, where injections occur almost continuously, manual recording becomes effectively unusable for predictive modeling, and even retrospective investigations can be immensely time-consuming. Modern CDS platforms offer limited solutions. While some tracking capabilities exist, these typically require expensive add-ons, such as RFID tagging systems, which work only with specific vendor columns. One chromatography user forum discussed RFID tag limitations, highlighting that even expensive systems often fall short due to user non-compliance, system design flaws, and the inherent cost and inflexibility of vendor-specific solutions. Many labs create workarounds using custom fields to capture column identifiers, but accessing this data for reporting requires either deep CDS expertise or manual export processes that reintroduce the original inefficiencies.
A Modern Solution for Automated Column Reporting
How Chromatography Insights Works
TetraScience’s Chromatography Insights app automates column reporting and logbooks by processing the raw CDS data through our data engineering framework, Tetraflow. This framework performs the complex task of transforming CDS data into analytics-optimized, AI-ready datasets within a structured lakehouse architecture.
The transformation process includes:
- Data harmonization across Waters Empower, Thermo Chromeleon, Agilent OpenLab CDS, and Shimadzu LabSolutions
- Real-time data pipeline processing that maintains data integrity and audit trails
- Structured data modeling optimized for rapid query performance and regulatory reporting
- Automated quality checks ensuring data completeness and accuracy
This enables rapid query and analysis while maintaining the complete traceability required for regulatory compliance. The data is also ready for a wide and growing range of specific use cases, such as automated report generation, performance trending, and out-of-specification event detection, as well as future AI/ML applications, including predictive column replacement modeling.
Automated Column Usage Reports
Users generate reports by searching with date ranges, method names, specific column identifiers, or particular compound names. The interface displays visual timelines showing the first injection date, last injection date, and total injection count for each column. Interactive filters enable teams to focus on specific time periods, while detailed tables provide complete injection and sample ID traceability, as required for regulatory documentation.
Visual Dashboards
The column usage plot returns two visuals that allow users to determine a column’s first and last injection dates and the total number of injections performed on that column. Additionally, the user can apply a slider filter on the plots to drill down to specific time ranges. The tabular report below creates a line-item readout listing all corresponding injection and sample IDs for complete traceability.
Flexible Configuration
Chromatography Insights’ latest enhancements add particular value by accommodating existing lab workflows, standard CDS column identifier fields, and organization-specific custom fields. The app uses standard CDS column identifier fields by default, but users have the option to define which column identifier to use, as some organizations elect to create custom fields for tracking column usage.
Our latest release enables users to adjust their search filter settings, allowing them to select either the standard column ID search or specify a CDS custom field. This creates a highly dynamic experience, allowing organizations to implement Chromatography Insights immediately without needing to reinvent their existing workflows. This means labs can implement automated reporting immediately without changing their current column tracking procedures or revalidating existing methods—a critical consideration for regulated environments.
Real-world Impact
Early adoption has demonstrated significant operational benefits and measurable ROI:
Quantitative Benefits
- Time savings: Organizations reduce column logbook utilization from 40+ hours monthly to under 5 minutes of automated report generation
- Cost reduction: Expected annual savings of $1,060,000+ in labor costs for large pharmaceutical operations
- Audit preparation: Compliance documentation preparation time reduced from days to minutes
Beyond efficiency gains, the feature improves data integrity and audit readiness. Digital traceability with complete timestamps and user tracking creates robust documentation that satisfies regulatory requirements while enabling predictive analytics for column replacement planning and performance trending.
Looking Ahead
The automated column logbook functionality represents our continued commitment to addressing the real operational challenges that analytical teams face daily. The underlying Tetraflow technology also lays the foundation for future AI applications that leverage the same analytics-ready datasets.
Upcoming capabilities include:
- Automated out-of-specification detection with real-time alerting
- Predictive maintenance scheduling based on usage patterns and performance trends
- AI-powered column replacement recommendations optimizing cost and performance
For existing Chromatography Insights users: The column reporting feature is available in your current installation. Contact your customer success manager to enable these capabilities.
For new organizations: See how automated column reporting, along with our comprehensive chromatography analytics suite, can transform your lab operations.
Ready to transform your column reporting processes? Contact us to request a technical demonstration.