Pharmaceutical manufacturing software built for cGMP — not adapted to it.
V5 Ultimate is a single-platform MES / QMS / LIMS / WMS for US pharmaceutical manufacturers under 21 CFR 210 and 211. Electronic batch records, deviations, OOS, CAPA, APR/PQR, sampling, calibration and warehouse — one validated instance, one audit trail, one login.
You need pharmaceutical manufacturing software because paper batches are the bottleneck.
Batch records reconcile a week after production — release is always late
Deviations sit in Word documents that CAPA never links back to
APR/PQR is a two-analyst, six-week annual exercise
OOS investigations restart from scratch every time — no phase logic
Lab, warehouse and QA operate in three unconnected systems
cGMP training compliance can't be shown for a specific operator on a specific date
cGMP capabilities that ship in the same instance.
Electronic Batch Records (eBR)
Recipe-driven, review-by-exception, weight/temperature/torque captured from equipment — signed step-by-step under Part 11.
Deviations & OOS
Phase-1 lab investigation → Phase-2 manufacturing → CAPA — timers, escalations and evidence bound to the affected batch.
CAPA & Change Control
Root cause, effectiveness check, change impact assessment — closed-loop with training, SOP and validation deltas.
APR / PQR automation
Annual Product Review pulls batches, deviations, CAPAs, OOS, complaints and stability into a countersigned report — hours not weeks.
Warehouse & sampling
GMP receipt, sampling, quarantine, release, dispensary — barcode-driven and integrated to the batch record.
Calibration & training
Every instrument reading and every signature checks the underlying equipment's calibration status and the operator's current training.
What cGMP manufacturing looks like when the software actually helps.
- Batch release cycle time cut from 5–7 days to 24–48 hours
- APR/PQR generation from weeks to under a day
- Zero-finding Part 11 audits on batch records and audit trail
- One instance covers manufacturing, lab, warehouse and QA — no integration project
- GAMP 5 Cat 4 validation pack delivered at onboarding — reviewed and countersigned by your QA
The regulations your GMP site is inspected against.
21 CFR Part 11
§11.10(e) audit trail, §11.10(f) operational checks, §11.10(g) authority checks, §11.50 / §11.70 signature manifestation and binding — all native, all reviewable.
EU GMP Annex 11
Risk management, validation, data integrity, e-signatures, printed-copy criteria, incident management, business continuity — covered out of the box.
GAMP 5 Second Edition
Category 4 configured product with documented critical thinking. CSA-aligned test evidence delivered with onboarding — not a six-month after-the-fact project.
Pharmaceutical manufacturing software, answered.
Is V5 an MES, a QMS, or a LIMS?
All three, on one platform. MES for batch execution and equipment integration, QMS for deviations/CAPA/change control/training/audit, LIMS for sampling and lab result management — one database, one audit trail, one signature stack.
Does V5 handle both sterile and non-sterile?
Yes. Sterile sites layer Annex 1 environmental monitoring, contamination control strategy (CCS) and aseptic-simulation records. Non-sterile sites deploy the same core without those modules.
How does V5 integrate with SAP or Oracle?
V5 sits between ERP and the shop floor. Standard integrations exist for SAP S/4HANA and Oracle Fusion — item master, BOM, batch consumption, GR/GI and financial postings.
Do you support outsourced (CMO/CDMO) manufacturing?
Yes. V5's contract-manufacturing model gives the sponsor visibility into batch records, deviations and release without granting write access to internal QA workflows.
What's included in the validation pack?
URS/FS/DS traceability, IQ/OQ/PQ scripts and evidence, validation summary report, and a signed shared-responsibility matrix. Your CSV team focuses on process-specific PQ.
See a cGMP batch executed end-to-end on your recipe.
Free trial. Validation evidence and Part 11 assessment included.