For bioanalytical CROs and laboratories
Stop losing days to manual run review, method scouting, audit preparation and transcription errors.
ARISENTO checks every run against ICH M10 or your SOP in seconds, drafts methods from evidence and keeps every record inspection-ready - so your scientists get their time back for science.
- On-premise first
- Designed for 21 CFR Part 11 & ICH M10
- AI that cites its sources
The bioanalytical lab reality
Your scientists are experts. Their week says otherwise.
Hours lost to manual work
Literature searches, compound property look-ups and method scouting restarted from scratch for every molecule.
Rework that should not happen
Troubleshooting starts from zero because earlier methods and fixes sit in notebooks, folders and inboxes - or left with the scientist.
Compliance as a burden
Review, re-review and QA queries on paper; audit trails assembled after the fact, the week before an inspection.
ARISENTO works next to your team: the system does the searching, checking and record-keeping - your scientists keep every decision.
See it in action
Upload a run. Get the review.
This is what your scientist sees seconds after the upload - not a spreadsheet to check, but a review to decide on.
- Verdicts per run
Calibration and QC acceptance against ICH M10 or your SOP. - Repeats with the reason
Above ULOQ, IS response, failed run - with the action to take. - Document cross-checks
Sample manifest, repeat reasons and protocol checked automatically. - AI note with a verified quote
Points to the protocol page it relies on.
The bioanalytical workflow
How much of your scientists' week goes into checking spreadsheets?
Six steps every bioanalytical lab knows - see what changes with ARISENTO.
Start every method from evidence
Today
- Compound properties looked up database by database
- Published methods searched and read one by one
- Earlier methods of the lab buried in folders and inboxes
With ARISENTO
- Compound data, published LC-MS/MS methods and MRM calculations in one draft, with sources
- Your lab's approved methods for the compound shown first
- Final method signed by the author and approved by a Manager
No more starting from a blank page - or developing a method the lab already has.
ICH M10 calculations, the same way every time
Today
- Each analyst's own spreadsheet and formula version
- A second person re-checks formulas and rounding
- Results typed across into the report
With ARISENTO
- One tested implementation for regression, weighting, accuracy and precision
- Consistent rounding, every intermediate value visible
- Same rules as the run review - one validation
No spreadsheet to build, verify and re-verify for every study.
Every run checked in seconds
Today
- CDS export copied into Excel
- Each standard, QC and blank checked by hand against the criteria
- Repeats listed manually, reasons in notebooks
With ARISENTO
- Upload the exports - every worksheet of every file is read
- Calibration, QC, carryover, IS, retention time, repeats and ISR checked against ICH M10 or your SOP
- Every finding points to file, sheet and row
The checking is done when the upload finishes - you review findings, not rows.
Protocol, SOPs and investigations in the review
Today
- Protocol and SOPs in binders next to the screen
- Sample manifest reconciled by hand
- Repeat reasons collected from e-mails
With ARISENTO
- Protocol, method, SOPs, investigations, manifest and scans attached to the study
- Missing samples, undocumented repeats and protocol mismatches found automatically
- The AI reviewer quotes the documents - every quote verified
Cross-checking documents against the data happens automatically.
Review, verification and approval in one record
Today
- Printouts, sticky notes and signature sheets
- Queries between scientist, QC and QA by e-mail
- Audit trail and records assembled before an inspection
With ARISENTO
- Each finding dispositioned, verified by QC, approved by QA - with e-signatures
- Queries go back to the scientist inside the review
- Audit trail recorded as you work, exportable at any time
Approval without chasing paper - and an inspection-ready record every day.
Instruments, standards and stability under control
Today
- Calibration due dates and expiries in separate spreadsheets
- Reminders depend on someone remembering
- Bulk data entered and checked by hand
With ARISENTO
- Instruments, calibration, stability pull windows, working standards and reagents in one register
- LC-MS/MS time booked in the scheduler - conflicts blocked, maintenance protected
- Excel imports with plausibility warnings and second-person verification
Nothing expires unnoticed - and nobody re-types a register.
One platform, every role
From the bench to the QA office
Methods built on evidence
Compound data, published methods and your lab's approved methods in one draft.
Runs reviewed in seconds
Every worksheet checked, every finding traced to its row.
Signed and inspection-ready
QC verification, QA approval and the audit trail - in one record.
AI you can check
The AI quotes your protocol - and every quote is verified
The local AI reads your protocol, method, SOPs and investigations and explains what needs attention. It must quote the document; every quote is checked word for word, and anything it cannot verify is removed.
- Rule-engine verdicts are final - the AI never accepts or rejects a run
- AI output is always marked advisory
- Scientist, QC and QA sign each step
One platform
Everything a bioanalytical lab runs on - in one system
Shared records, one audit trail, one set of e-signatures.
AI Data Review
Every calibrator, QC and blank checked against ICH M10 or your SOP - with the study documents and an AI that cites them.
Method development
Compound in - pKa, logP and ionisation, feasibility flags and a draft LC-MS/MS method with sources out.
Troubleshooting assistant
Backpressure spikes, retention-time drift, split peaks, IS response - causes and checks from your lab’s own history.
Validated calculators
1/x² weighted regression, %bias, precision, molarity and C1V1 dilutions - deterministic, server-side, no AI in the maths.
Lab operations
Working standards, reagents, instrument calibration and stability pull windows - with reminders before anything expires.
Instrument scheduler
LC-MS/MS time booked, conflicts blocked, maintenance windows protected.
Quality
Deviations, CAPA, change control and a versioned SOP and guideline library.
Lab memory
When senior scientists move on, their methods and troubleshooting logic stay - searchable, approved, inside your facility.
Controlled output
Every print, PDF and export logged in the audit trail - controlled copies, ready for the inspector.
Compliance & security
Built for regulated science
Designed to support 21 CFR Part 11, EU GMP Annex 11 and ALCOA+, with a validation pack for qualification in your environment.
- Append-only audit trail, enforced in the database
- Electronic signatures with re-authentication and meaning
- Two-factor sign-in, password policy, lockout, session lock
- Reason required for every correction of recorded data
- Read-only - never locked - when a licence expires
- On-premise first; cloud AI only through approved change control
Deployment
Runs where your data has to stay
On-premise first - with the flexibility your IT and QA teams need.
See it with your own data
Frequently asked questions
Who is ARISENTO for?
Bioanalytical laboratories that work to regulatory standards - CROs, pharmaceutical and biotech bioanalytical departments and GLP laboratories - for LC-MS/MS and ligand-binding assays. Scientists, QC reviewers, QA and lab management work in the same system.
Where does ARISENTO run - and does our data leave our network?
ARISENTO is on-premise first: it runs on your own server, in your data centre or in your organisation's private cloud (for example a virtual machine in your AWS, Azure or Google Cloud account), with a local AI model. Run data and documents stay in your environment, and it can operate without internet access. If you choose hybrid mode, selected AI requests can go to a cloud AI provider under your own contract - only after a configuration request, a connection test and QA approval with electronic signature. Every cloud request is logged and the connection can be switched off immediately.
Is ARISENTO validated?
ARISENTO is designed to support 21 CFR Part 11, EU GMP Annex 11 and ALCOA+, and comes with a validation pack: control mapping, requirement traceability, an automated OQ runner and a UAT checklist. Validation for your intended use is performed by you, in your environment - as for any computerised system - with our support.
Can the AI accept or reject a run?
No. A rule engine applies ICH M10 or your SOP values and its verdicts are final. The AI explains and points to evidence, quoting your documents; every quote is verified, and people sign each review step.
Which data and systems does it work with?
Run exports from your chromatography data system or LIMS as CSV or Excel - every worksheet is read - and your own Excel sheets. Study documents as PDF, Word, Excel, CSV or scans (PDF, JPG, PNG, TIFF), with text recognition on the server.
Does ARISENTO replace our LIMS or CDS?
No. Your CDS acquires and integrates the data and your LIMS manages samples. ARISENTO works alongside them: method development, run review, lab operations and quality records - with one audit trail.
What server do we need?
A Linux server or virtual machine (Ubuntu, Debian, Red Hat and compatible; on Windows Server as a Hyper-V or VMware virtual machine): minimum 8 vCPU with AVX2, 32 GB RAM and 100 GB SSD; recommended 16 vCPU, 64 GB RAM and 200 GB NVMe. A GPU option is available for many simultaneous AI users.
How is ARISENTO licensed?
Per organisation, as an annual licence with support, updates and maintenance. You receive a quotation after the demo, tailored to your laboratory.
See ARISENTO with your own data
A 45-minute walkthrough of method development, AI Data Review and the compliance controls - with your own run files.