From the first pull to a signed CoA in your customer's hands.
One connected QC loop. The analyst runs the sample on the kiosk; the result lands on the chart; an out-of-spec opens its own investigation, spawns a CAPA, holds the batch and routes the disposition; the released lot's Certificate of Analysis is built from real values, signed under §11.50, and delivered to the customer portal with every view logged. No spreadsheets. No retyping. No quiet edits.
Follow a sample across the operator kiosk.
Not a transcribed clipboard. Not a paper batch record retyped later. The analyst's screen is the source of truth — login, method, materials, instrument, notes, pass/fail. Every step writes a real row with a real signature.
Analyst taps in. The bench inherits their certifications — methods they aren't current on are dimmed before they pick a sample.
- Analyst
- K. Chen · ID 0241
- Active certs
- LM-218, LM-303, LM-117
- Lapsed
- LM-440 (renews 2026-09-02)
If the analyst presses Fail (OOS) at step 7, the next four sections of this page are what happens automatically.
Trends become alerts before they become an excursion.
Every captured result fires a database trigger that writes to the active baseline, evaluates Westgard 1₃ₛ, 2₂ₛ, R₄ₛ, 4₁ₛ and 10ₓ, and updates Cp / Cpk on the spot. When a confirmed OOS lands, the next four things happen without a human chasing them.
- No flags. SPC nominal — keep running.
One failing result. Four possible dispositions. The batch can't release until one is signed.
The OOS opens a deviation. The deviation routes a CAPA. The CAPA's disposition gates lot release. If the choice is rework, the work order gets a correction step, the lot is re-sampled, and the second pass runs through the same method, the same SPC chart and the same signatures.
- › lab_oos_investigations
- › linked: run · instrument · reagent lot · analyst
- › status: investigating → closed
- › scope: WO-9821 · lot L-78214
- › actions: containment · root cause · corrective · effectiveness
- › tracked in /app/quality/capas
- WO opens a corrective step (blend-back, re-dilute, re-blend)
- Re-sample request fires when the step closes
- Re-test runs the same method · SPC re-captures
- Lot disposition flips to 'released' only on the second pass
Rework opens a work-order corrective step (blend-back, dilute, re-mix). It's planned, signed and time-stamped — not a verbal patch.
Lot.disposition + lot.release_sig_id won't write without the deviation_closed signature on the linked CAPA.
Every CAPA carries an effectiveness check date. If the same cause re-occurs inside the window, V5 flags the CAPA as ineffective and re-opens it.
CoA built from real results, signed under §11.50, in the customer's portal in minutes.
Not a Word template. Not an "export to PDF" workflow run by an admin. The Certificate of Analysis assembles itself from lot_test_results, requires a QA e-signature, stamps the lot record, and lands in the customer's portal — with every download and view recorded in the audit log.
| Test | Method | Specification | Result | Outcome |
|---|---|---|---|---|
| Assay (HPLC) | LM-218 | 98.0 – 101.5 % | 99.42 % | ✓ Pass |
- Assemble from lot_test_results5 tests · all pass
- QA e-sign · coa_approvedJ. Liu · §11.50 · 09:58
- Lot stamped · release + coa_urllots.disposition → released
- Pushed to customer portalACME Pharma · CUST-118
- Customer downloaded & viewedlogged · audit-grade timestamp
A full LIMS, ELN and SPC stack — wired to the rest of the platform.
Eight capabilities. Every one of them pinned to a real table, a real trigger and a real route in the running product. Nothing here is slideware — your lab can open the page and find it.
Plans that fire themselves — in-process, finished, stability, environmental
Sample plans bind to a product, a step, a process line or a stability protocol. When the trigger fires — work-order release, in-process step, stability pull window — the plan opens a sample request, routes it to the right bench, and starts the clock. AQL tables drive container counts. Nothing is logged after the fact.
Reagents are first-class WMS items — not a side spreadsheet
Every reagent points at a stocked item. Lots are real lots in the warehouse. Sub-aliquots, working solutions and titre standards inherit genealogy from the parent lot. Expiry is live. The SDS sits in document control. The bench can't open a run with an expired reagent — the method gate blocks it.
Instruments live in the asset register — cal status flows through
Every instrument is an asset. Calibration due, calibration verified, location, condition and condemn status all live in the asset register. A test run binds the instrument by asset_id; if the asset's calibration has lapsed or its condition is OOS, the run is hard-blocked. Move an asset to a new suite, the lab sees it.
Control charts that build themselves at the moment of result
When a result is captured, a database trigger writes it into the SPC results table against the active baseline, evaluates Westgard multi-rules (1₃ₛ, 2₂ₛ, R₄ₛ, 4₁ₛ, 10ₓ), and updates Cp / Cpk vs LSL/USL. Baselines are locked with a signature — you can't quietly re-baseline a drifting assay. The chart is the source of truth, not a screenshot.
Stability — protocol once, pulls scheduled for years
Define a protocol (conditions, time points, tests per point). Open a study against a lot. V5 schedules every pull — 1, 3, 6, 9, 12, 18, 24, 36 months — auto-creates the sample request as the window opens, pages owners on the day, and folds excursions into a structured deviation if a chamber trips. Real ICH Q1A territory, not a spreadsheet.
ELN entries are immutable at the database level — not by policy
The lab notebook isn't a Word doc. Every entry is captured against a run, a sample, a method or a study, with attachments, calculations and signatures. A database trigger blocks update / delete after lock — corrections go through a supersession chain so the original stays readable forever. Witness signatures where the SOP demands them.
Out-of-spec opens a structured investigation — not a free-text form
An OOS result auto-quarantines the sample, opens an investigation record bound to the run, the instrument, the reagent lot, the analyst and the method rev — and links to the active baseline. Retest rules are governed by the method, not by negotiation. Averaging traps (the Barr ruling territory) are blocked by design. Closure feeds CAPA.
Only certified analysts can run the method — checked at the bench
Every method names the analyst certifications it requires. Certs have effective and expiry dates and live in the same skills matrix the floor uses. The bench can't start a run if the logged-in analyst isn't current. Lapsed certs auto-route to retraining; the underlying competency record sits next to the operator's WO competencies, not in a parallel HR sheet.
One platform — the lab plugs into everything that matters.
Two rings. The inner ring is the rest of V5 — already wired, no middleware, one audit trail. The outer ring is the hardware and third-party systems your bench already runs.
Reagents are stocked items; samples inherit source_lot_id from the warehouse. Expiry and quarantine flow through automatically.
Instruments are assets. Out-of-cal hard-blocks the run; calibration certs link directly to lab_test_runs.
A passing lab result re-evaluates the bound eBMR step; a late result auto-amends the sealed record under controlled change.
Methods, SOPs and SDS sit in the central doc register. Method rev is pinned at run start — published changes can't drift under a live run.
Analyst certifications are the same competency records the floor uses — one source for who can do what, not an HR parallel.
OOS investigations and Westgard-trip deviations route straight into CAPA with the run, lot, instrument and analyst already linked.
Released results feed the customer CoA and the on-pack label data — never retyped from a printout.
Mettler, Sartorius, Ohaus, Hanna over RS-232/USB/Bluetooth — captures stable readings with the asset bound.
Empower, Chromeleon, OpenLab, MassHunter — integration over result-file watch folders or vendor API. Method ID and run ID both bind.
Process and benchtop spectrometers — bring your own model; V5 stores the spectrum, the chemometric output and the call.
TECAN, BMG, Metrohm — endpoint, kinetic or potentiometric runs land against the sample with the well-map preserved.
Already on LabWare, STARLIMS or LabVantage? V5 can ingest results via SDC bridge while the floor stays on V5 — full handoff is optional.
Chamber temperature, humidity and pressure tags from PLCs or standalone loggers — bound to stability studies for excursion handling.
Just ask V5 — it knows the product cold.
Pick a question or type your own. V5 answers grounded in how lab & qc — lims, eln, spc, oos, capa and coa | v5 ultimate actually behaves on the floor.
The rest of the platform this plugs into.
V5 isn't a bolt-on. Every module shares the same data, the same audit trail, the same operator. Pick where to look next.
QMS
Built-in QMS: deviations, CAPA, supplier scorecards, in-process AQL, release-by-exception. Aligned with 21 CFR 211/820, ISO 13485 and 111.
eBMR / eDHR
MMR snapshot at WO release, BMR/DHR fills itself in as operators work, rendered live from immutable data. Built for 21 CFR 211.188 and 820.184.
Calibration
Every gauge, scale, probe and instrument tracked on a calibration schedule with vendor cert PDF, tolerance and as-found / as-left readings. Overdue equipment is blocked from writing to any regulated record — enforced per 21 CFR 211.68, 820.72 and ISO 17025.
21 CFR Part 11
Re-authentication, signature meaning, immutable record snapshots, append-only audit trail at the database layer. Part 11 isn’t a checkbox — it’s how V5 is wired.
Labels
Design finished, shipping, intermediate and sample labels in a mm-calibrated canvas. GS1-128, QR, DataMatrix, Nutrition Facts. Independent-reviewer e-signature locks the version. Every preview, PDF and ZPL captured to a Part 11 reprint audit trail. NiceLabel / Loftware replacement built into your QMS.
Lot traceability
One-query forward and backward genealogy. ‘Where did vendor lot RW-228 go?’ returns every WO, finished lot and customer ship-event in seconds.
Got questions, or want to see it on your shop floor?
Ask V5 — our code-aware assistant — or spin up a workspace. Both are free.