Long-term Study Archiving
Preserve Watson LIMS™ Study Data through Human-Readable Long-Term Archiving
A complete, regulator-ready archive for bioanalytical and clinical study data — human-readable, audit-proof for decades, with no dependency on the originating WATSON LIMS™. Designed to outlast both extended retention requirements and rapidly evolving software lifecycles.
Long-Term Study Archiving
Preserve Watson LIMS™ Study Data through Human-Readable Long-Term Archiving
A complete, regulator-ready archive for bioanalytical and clinical study data — human-readable, audit-proof for decades, with no dependency on the originating WATSON LIMS™. Designed to outlast both extended retention requirements and rapidly evolving software lifecycles.
Designed for a 25-year retention period
Six Properties of a Future-Proof Study Archive
Human-Readable Archives
Every study exported as PDF/A — reviewable without Watson or any specialized software, ready for regulatory inspection at any time.
Multi-Format Output
PDF/A for human reading, CSV for Excel-based analysis, and XML for data warehouse imports — all from a single archiving run.
Built-In Data Integrity
SHA-256 hashes for every file, with a master checksum and a hash-of-hashes mechanism for tamper-evident verification.
Fully Configurable
Define the scope of files generated, the Watson data fields included, and extend the archive with manually uploaded documents.
Consistent with Submissions
Report tables match prior submission documents — including concentration significant figures and statistics not natively available in Watson.
Minimal Validation Effort
ISO 9001:2015 certified development, GAMP 5 aligned, with full vendor qualification documentation — only the business cycle test on your side.
Human-Readable Archives
Every study exported as PDF/A — reviewable without Watson or any specialized software, ready for regulatory inspection at any time.
Multi-Format Output
PDF/A for human reading, CSV for Excel-based analysis, and XML for data warehouse imports — all from a single archiving run.
Built-In Data Integrity
SHA-256 hashes for every file, with a master checksum and a hash-of-hashes mechanism for tamper-evident verification.
Fully Configurable
Define the scope of files generated, the Watson data fields included, and extend the archive with manually uploaded documents.
Consistent with Submissions
Report tables match prior submission documents — including concentration significant figures and statistics not natively available in Watson.
Minimal Validation Effort
ISO 9001:2015 certified development, GAMP 5 aligned, with full vendor qualification documentation — only the business cycle test on your side.
From Standard Archiving
to Vendor Independence
Your Data
Your Archive
Your Choice
In regulated bioanalytical environments, long-term access to study data is non-negotiable – regardless of which LIMS platform is currently in operation. StudyGen Plus Archive serves as the standard human-readable archiving solution for Thermo Scientific™ Watson LIMS™, generating a complete study data archive that can be accessed and inspected without any dependency on the Watson system itself. This vendor independence becomes a critical strategic advantage in two key scenarios: when organizations need to decommission Watson in favor of a next-generation LIMS platform, or when system consolidation is required during mergers and acquisitions. In both cases, StudyGen Plus Archive ensures that all historical study data remains fully accessible, audit-ready, and compliant with 21 CFR Part 11- long after the original LIMS has been retired. Rather than being locked into maintaining legacy infrastructure solely for data access purposes, organizations can confidently transition to new systems while preserving their complete regulatory archive. StudyGen Plus Archive turns what is often a costly and complex migration risk into a straightforward, future-proof archiving strategy.
Three Formats. One Consistent Archive Package. Zero Dependencies.
Human-Readable Documents
Document stack structured by run and by study. Inspection-ready without proprietary tooling (e.g., PDF/A).
- Individual analyte reports
- Calibration & regression data
- Run performance statistics
- Reassayed & incurred samples
- Complete audit trails
Analyst-Friendly
Tables
Tabular exports designed for direct processing in Microsoft Excel and statistical environments (e.g., CSV).
- Raw response values
- Calibration data
- Processing information
- Per-run audit trail
System-to-System
Imports
Structured XML for automated ingestion into data warehouses and downstream analysis platforms (e.g., XML).
- Schema-validated structure
- Per-run & per-study segmentation
- Full metadata preservation
- Pipeline-ready
Six Table Types — Inspection-Ready, Without Preparation
A study archive is only as complete as its weakest record. StudyPlus Archive generates six structured report types — in PDF/A, CSV, and XML — covering every layer of a bioanalytical run: from regression parameters and calibration data to QC performance, processing details, and the full Watson LIMS™ audit trail. Each report type is consistently formatted and independently accessible, so an inspector can navigate your archive without guidance, a LIMS login, or a subject matter expert in the room.
General Study Information
Study metadata, scope, and summary-level information rendered as PDF/A with structured CSV/XML companions.
Analytical Run Assay
Full assay metadata: assay type, biological matrix, species, instrument interface, regression parameters, standards, QCs, acceptance limits.
Regression Analysis
Regression type, weighting factor, slope, intercept, R-squared, LOQ/ULQ, and the run acceptance template applied.
Run Performance
Calculated concentrations for standards and QCs, mean values, %CV, %Dev — including statistics not stored natively in Watson.
*also available for other LIMS solutions – ask us about integration with your specific solution!
Key Benefits
Future-Proof Accessibility
Your archive remains readable on standard tools (PDF/A, CSV, XML) for decades — independent of the originating LIMS, vendor, or hardware. No format lock-in, no expensive forced migrations down the line.
Audit-Ready Compliance
Generate regulator-ready archives that satisfy 21 CFR Part 11 by design. Be inspection-ready every day of the retention period, not just in the weeks leading up to an audit.
Verifiable Data Integrity
SHA-256 hashes for every file, anchored by a tamper-evident master checksum. Any change to any byte is detectable in seconds — your record stays defensibly trustworthy for the full retention window.
Minimal Validation Effort
GAMP 5 vendor-qualified with complete validation documentation. Reference our package, run the business cycle test on your side, and move on — no need to re-validate from scratch.
Unlocked Historical Data
Reuse decades of bioanalytical data for cross-study analysis, retrospective reviews, and reanalysis with newer techniques. One search delivers what used to take weeks of archive digging.
Lower Total Cost of Ownership
Decouple your archive from active LIMS licenses, version upgrades, and proprietary infrastructure. Store on standard, low-cost infrastructure for a fraction of legacy maintenance costs.
When Vendor Independence Becomes a Strategic Advantage
Incl. Post-Merger Consolidation
21 CFR Part 11 · EU GMP Annex 11
Your Journey Starts Here
Make your study archive future-proof. Talk to us about how StudyGen 360 Plus Archive fits into your bioanalytical or clinical study workflow — and your validation strategy.
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
Make your study archive future-proof. Talk to us about how StudyGen 360 Plus Archive fits into your bioanalytical or clinical study workflow — and your validation strategy.
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!