LIMS software that ships in weeks, not two-year implementations.
V5 Ultimate is a Laboratory Information Management System (LIMS) built for regulated QC, stability and micro labs. Sample login, worklists, instrument capture, OOS / OOT investigation, stability protocols and one-click CoA — on the same platform as the eBR and QMS, so the batch, the lab result and the release decision are one thread.
You searched LIMS software because the QC spreadsheet is finally breaking.
Sample login is a paper worklist and a shared Excel file
HPLC and GC results are printed, initialled and stapled to the batch record
OOS investigations live in Word docs no one can find at inspection
Stability studies are tracked on a wall calendar and re-typed at pull
Enterprise LIMS quotes are $1M+ and 12-24 months
The lab is the last place data integrity findings still surface
Everything a regulated QC lab actually runs.
Sample login & worklists
Barcoded sample login by batch, stability pull, environmental round or incoming material — worklists routed to analyst, method, instrument and shift. Chain-of-custody signed at every handover.
Instrument capture (HPLC, GC, balance, pH, titrator)
Bidirectional integration with Empower, Chromeleon, LabSolutions and OpenLab plus direct capture from balances, pH meters and titrators — no keyed transcription, no paper printout to staple.
OOS / OOT investigation, native
FDA-2006-style Phase 1a / 1b / 2 investigation modelled as workflow — hypothesis, retest, root cause, CAPA, QA disposition. Every OOS closes inside V5, cited to the original result.
Stability by ICH Q1A / Q1E
Protocol design, pull-point scheduling, condition management (25/60, 30/65, 40/75), trending against acceptance criteria and Q1E-style shelf-life extrapolation — one live study, not a spreadsheet.
Certificate of Analysis (CoA)
Bound to the batch record and the lab worksheets — every value on the CoA traces back to the instrument event that produced it. One click, one signed PDF, one export.
21 CFR Part 11 for the lab
Every result, every review, every re-integration is audit-trailed with reason. Second-person review is enforced, not encouraged. Data-integrity findings in the lab stop showing up.
What changes the day this goes live.
- Sample-to-CoA cycle time drops 40-70% because there's no re-typing between systems
- OOS investigations close in days, not weeks — every one cited to the original data
- Stability pulls stop being missed because V5 owns the schedule and the reminder
- Lab data-integrity findings drop because Part 11 controls are native to the workspace
- QA release is one thread — batch, lab, deviation, CAPA, CoA — not five
LIMS built against the standards QC labs are actually audited against.
21 CFR Part 11 · EU GMP Annex 11
Audit trail, bound e-signatures, second-person review, printed-copy criteria — native to every sample, worksheet and CoA.
ICH Q1A(R2) · Q1E · Q2(R2)
Stability study design and shelf-life extrapolation, plus analytical procedure validation — modelled as protocol, executed as workflow, evidenced as one record.
ISO/IEC 17025
For accredited testing labs — competence records, method validation, measurement uncertainty, proficiency testing and traceability of measurement, all in-system.
See the ISO/IEC 17025 view — scope, method validation and measurement uncertainty in one system.
LIMS software, answered.
Is V5 a full LIMS or a bolt-on to your MES?
V5 is a full LIMS — sample login, worklists, instrument capture, results review, OOS/OOT, stability, CoA and Part 11 e-signatures are all native modules, not shims. The advantage over a standalone LIMS is that the batch, the lab result and the release decision live in the same audit trail.
How does V5 compare to LabWare or STARLIMS?
LabWare and STARLIMS are enterprise LIMS built for very large, highly customised labs — powerful, expensive and slow to deploy. V5 LIMS targets the 20-500 person regulated plant where the alternative today is a spreadsheet or a stalled enterprise-LIMS project. If you already run LabWare or STARLIMS, V5 integrates rather than replaces — bidirectional bridges are supported.
Can V5 handle stability?
Yes. Protocols follow ICH Q1A(R2), pull points are scheduled and reminded, trend plots are generated automatically, and shelf-life estimation uses Q1E-style regression. Micro and physical / chemical tests both sit on the same protocol.
Which instruments integrate?
Empower, Chromeleon, LabSolutions, OpenLab CDS for chromatography; Sartorius / Mettler / OHAUS balances; Metrohm / Mettler titrators; Thermo / Hanna pH; and a generic serial / TCP capture for anything not on that list. Bidirectional where the vendor exposes it, one-way capture otherwise — always signed and never keyed.
How long to go live?
First signed CoA on V5 typically inside 30 days for a single-product QC lab, 60-90 days for a full multi-product QC + stability + micro rollout with instrument integrations.
Give the lab one signed record — sample to CoA.
Free trial. Real instruments. First signed CoA inside 30 days.