StudyPlus
Smart Archiving, Analytics and Lab-Specific Capabilities
As the extendable layer of StudyGen 360, StudyPlus delivers proven long-term archiving and configurable KPI monitoring, with the flexibility to adapt to your laboratory’s needs.
Smart Archiving, Analytics and Lab-Specific Capabilities
As the extendable layer of StudyGen 360, StudyPlus delivers proven long-term archiving and configurable KPI monitoring, with the flexibility to adapt to your laboratory’s needs.
StudyPlus
Delivering Measurable Results that Maximize Data Value
Archiving
Vendor-independent: human-readable archives in PDF/A, CSV, and XML, accessible any time without proprietary software.
Tamper-evident and compliant: sealed with a SHA-256 hash and aligned with 21 CFR Part 11.
A proven pathway for Watson LIMS™ decommissioning: retire legacy systems while keeping every study fully preserved and accessible.
KPI
Configurable to how your lab works: define the performance indicators that matter and monitor them on your terms.
Interactive dashboards and automated reporting: access the metrics each role needs across all study operations, lab-wide or per individual study.
Trend analysis and comparison: turn study data into evidence-based decisions.
Intelligent
A smart plus: automation and built-in checks applied to your study data from the start.
Reduces manual effort: keep every result traceable and reliable.
Complete audit trails: receive full ALCOA+ data integrity throughout.
Custom
Your plus, extended: capabilities built for your lab needs and added to StudyGen 360 on request.
Shaped to your workflow: fill gaps the standard modules don’t yet cover.
GxP standards: built on the same requirements as the rest of the platform.
Archiving
Vendor-independent: human-readable archives in PDF/A, CSV, and XML, accessible any time without proprietary software.
Tamper-evident and compliant: sealed with a SHA-256 hash and aligned with 21 CFR Part 11.
A proven pathway for Watson LIMS™ decommissioning: retire legacy systems while keeping every study fully preserved and accessible.
Intelligent
A smart plus: automation and built-in checks applied to your study data from the start.
Reduces manual effort: keep every result traceable and reliable.
Complete audit trails: receive full ALCOA+ data integrity throughout.
KPI
Configurable to how your lab works: define the performance indicators that matter and monitor them on your terms.
Interactive dashboards and automated reporting: access the metrics each role needs across all study operations, lab-wide or per individual study.
Trend analysis and comparison: turn study data into evidence-based decisions.
Custom
Your plus, extended: capabilities built for your lab needs and added to StudyGen 360 on request.
Shaped to your workflow: fill gaps the standard modules don’t yet cover.
GxP standards: built on the same requirements as the rest of the platform.
Your Plus in Study Handling
Your Study Data
Working for You
at Every Stage
StudyPlus looks beyond the individual run to the study and the laboratory as a whole. Long-term archiving and configurable KPI monitoring are where it starts: one keeps every completed record compliant and accessible, the other turns live data into a clear view of how your lab is performing. Yet the same data can do far more. Built to be extended, StudyPlus leaves room for applications tailored to your lab, from study and laboratory quality to capacity and utilization. Your study data works for you at every stage, helping your lab run cost-efficiently and stay competitive.
Core Benefits
Analytical
Advanced analytics and KPI monitoring turn study data into evidence-based decision support.
Archival
Regulatory-compliant, tamper-evident long-term archiving that stays human-readable and permanently accessible.
Accessible
A flexible plus layer where lab-specific capabilities can be added on request, without waiting for a full product release.
Automated
Intelligent automation that cuts manual processing while ensuring regulatory compliance and data integrity.
Assured
Proven data management technology with comprehensive validation, regulatory expertise, and long-term support.
Integrated
Connects with your LIMS, instruments, and existing systems across the StudyGen 360 ecosystem.
Advance Your Study Data Archiving
StudyPlus Archive is a comprehensive long-term archiving solution for bioanalytical studies managed in Thermo Scientific™ Watson LIMS™. It generates a complete, human-readable study data documentation package that meets regulatory requirements for study reviews and inspections, without additional proprietary software to access the archived data.
Developed for GLP and GCP environments, it ensures full compliance with 21 CFR Part 11 by providing accurate, complete copies of records in both human-readable and electronic forms, suitable for inspection, review, and copying by regulatory agencies.
Long-Term Human-Readable Access at Any Time
Eliminates System Dependencies
Access archived data without Watson LIMS™ knowledge or additional applications, ensuring long-term data accessibility regardless of system changes.
Flexible Data Organization
Archive information structured by experiment or any area of interest, supporting both regulatory compliance and ongoing research activities.
Accelerated Regulatory Processes
Readily available documentation accelerates regulatory submissions and audit responses by providing instant access to study records.
Improved Operational Efficiency
Reduce data retrieval time by up to 80% and enhance research continuity with easily accessible, interpretable archived data.
StudyPlus Archive generates complete study data documentation as flat files in a directory structure (PDF/A, CSV, XML). Designed for bioanalytical and clinical studies in GLP and GCP environments, including validation studies, in compliance with FDA 21 CFR Part 11, sections 11.10(b) and 11.50.
From Active Study to Long-Term Retention
Lifecycle, LIMS archiving, and data integrity on two pages. Share it with your QA and IT.
When Vendor Independence Becomes a Strategic Advantage
Incl. Post-Merger Consolidation
21 CFR Part 11 · EU GMP Annex 11
ALCOA+ Compliance, Built into Every Archive
Performance Monitoring that Drives Continuous Improvement
Priorities differ from one lab to the next. StudyPlus KPI is built to match yours, fully configurable to the indicators that count: throughput, turnaround, run acceptance, QC trends, backlog, and deviations, set against your lab’s thresholds and targets. Follow them lab-wide for the management view across every study, or drill into a single study when you need a closer look. When new data is available, StudyPlus flags it, and you refresh on your terms, so what you see is always current and always under your control.
Why it matters day to day
See it when it matters
A drifting assay or growing backlog is visible as it develops, while corrections are possible.
Automated by default
Built-in dashboards and reports replace spreadsheets and manual compilation.
The view for each role
Management follows the lab-wide picture while study teams track their own study.
Built on your real data
KPIs are drawn from your study data, reflecting your lab’s current status.
StudyPlus within StudyGen 360
Advanced Data Management Innovation
As the strategic intelligence layer of the StudyGen 360 ecosystem, StudyPlus keeps study data valuable at every stage, turning live data into operational KPIs, preserving the completed record long term, and extending it with custom capabilities built to your lab’s requirements.
It also closes a regulatory gap. The FDA requires electronic data to stay available in human-readable form for audit long after a study ends, yet established CDISC submission standards were not designed to cover every type of bioanalytical record. StudyPlus keeps that record compliant and accessible regardless.
Within the ecosystem, StudyPlus works alongside the modules that run the active study, StudyReporter, StudyLab, StudyConnect and StudyInsight, adding the long-term archive, the KPI view and the room to extend that round out the platform.
StudyGen 360 Integration Advantage
Within the StudyGen 360 ecosystem, StudyPlus seamlessly integrates with StudyReporter for comprehensive reporting analytics, StudyLab for laboratory performance monitoring, StudyConnect for enhanced data integration, and StudyInsight for quality oversight intelligence. This integrated approach provides unprecedented visibility into study performance and supports informed decision-making.
What this means for Pharmaceutical Development
Less time on data
Automation cuts manual archival effort by up to 90%, so your team spends it on science, not paperwork.
Audit-ready, always
When an inspection comes, the complete record is already compliant and human-readable, nothing to reconstruct.
No lock-in risk
Retiring a system never puts your data or compliance at risk.
Decisions, sooner
Live KPIs surface issues while a study is running, not after.
Relevant Industries
Large AND Small Molecules
Advanced reporting for PK/PD studies, method validation, and bioequivalence trials. Automated generation of calibration curves, dilution summaries, and statistical analyses with built-in validation checks.
Multi-Run Assay Control
Multi-run QC management with automated trend analysis, statistical process control, and real-time monitoring. Intelligent assay drift detection, outlier assessment, and run-to-run comparability with regulatory-compliant documentation.
Immunogenicity
Comprehensive immunogenicity evaluation tools with automated ADA screening, confirmatory assays, and neutralizing antibody assessments. Statistical evaluations tailored to regulatory requirements.
Stability
Dedicated stability testing workflows with automated trend analysis, shelf-life predictions, and regulatory-compliant stability reports. Real-time monitoring of critical quality parameters.
Your Journey Starts Here
Streamline your operations with an integrated long-term data archive and KPI analysis. Experience the power of StudyGen 360’s integrated platform.
Scalable Solution for any Lab Size
Whether you’re a small research lab or a large pharmaceutical company, StudyGen 360 scales with your needs. Learn more here!
Your Journey Starts Here
Streamline your operations with an integrated long-term data archive and KPI analysis. Experience the power of StudyGen 360’s integrated platform.
Scalable Solution for any Lab Size
Whether you’re a small research lab or a large pharmaceutical company, StudyGen 360 scales with your needs. Learn more here!