Bioanalytical electronic notebook
The lab notebook built for bioanalysis
BioELN replaces the paper notebook for regulated LC-MS/MS work — from reference standard to signed run — with every step audited, reviewed and ready for inspection.
Purpose-built, not pieced together
Generic ELNs hand you building blocks and leave the assembly to you. BioELN gives you screens shaped like the bioanalytical workflow you already follow — so analysts record the work, not the software.
How it works
Four records. One continuous, signed trail.
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01
Receive & verify
Log a reference standard, attach the CoA, work the verification checklist and get it signed off — it’s registered automatically and released on approval.
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02
Prepare solutions
Build stock and working solutions from anything already in the registry. Components save as you go; concentrations calculate themselves.
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03
CAL/QC batches
Check off today’s levels against the method’s protocol. One signature approves the whole batch — every level stays individually traceable.
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04
Record the run
Materials consumed, procedure notes and instrument output attached as evidence — reviewed, signed and locked.
Why labs choose BioELN
Everything a regulated lab needs — nothing it doesn’t
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Compliance built in, not bolted on
Every entry, change and signature lands in an append-only audit trail — who, what, when and why — designed around 21 CFR Part 11 and ALCOA+.
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Review & e-signatures with real segregation of duties
Submit to a named reviewer; a different person signs with password or PIN re-entry. Corrections require a reason and send the record back through review.
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Concentrations calculated for you
Purity-corrected weighings, C₁V₁ = C₂V₂ dilutions and real unit conversions — per analyte, for multi-analyte methods too.
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Protocol-driven CAL/QC batches
Define each level’s recipe once. Batches follow it automatically — cascades, diluent volumes, and a level that lands ≥5% off nominal is refused.
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Inventory that keeps itself honest
Stock is decremented the moment it’s used. Unique system IDs, printable barcode labels, scan-to-select, and expiring-soon and low-stock lists.
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ICH M10 method validation
Frozen validated-method snapshots, calibration ranges, stability windows and validation experiments — study runs are gated on a validated method.
Enterprise ready
Security your QA team will sign off on
Built to pass an audit, not just a demo — with the access controls and evidence inspectors expect.
- Single sign-on (OIDC) with zero-access provisioning
- Two-step login with any authenticator app
- Signature PIN as an independent second factor
- Login activity log and unauthorized-use alerts
- Requirements-traceable validation (CSV) evidence
- Method-wide and global search
Focused by design
One job, done exceptionally well
BioELN is the preparation and notebook layer of your bioanalytical lab — and deliberately nothing more. It works alongside the systems you’ve already validated instead of competing with them.
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Stays with your preferred LIMS (ex: Watson)
Data analysis
Regression, %RE/%CV and batch acceptance remain in the validated tools that already do them well. BioELN attaches their output as signed evidence, and their pass/fail result gets its own independent review.
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Stays with your LIMS
Sample tracking
Per-sample chain of custody, ISR and reassays stay where they belong. BioELN logs each shipment and the run’s procedural record — nothing duplicated.
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Stays with your QMS
SOPs & training
SOPs and training records stay in your quality system. BioELN works from them — and captures a signed “read and understood” for every method before anyone can review.
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Built for LC-MS/MS
One assay type, done right
Purpose-built for chromatographic quantitation under ICH M10 — no generic compromises to accommodate every assay format.
The result: a smaller validation footprint, no duplicated data, and one clear source of truth for every record.
See BioELN on your own workflow
We’ll walk you through receiving a standard, preparing a CAL/QC batch and signing a run.
Request a demo