Pharma MES · eBR · QC · Release
Pharmaceutical manufacturing from dispensing to QA release.
Dispense, run and record the batch at the station; QA reviews and makes the release decision.
Assay-corrected dispensing at the scale
V5 computes the as-is charge from the COA assay, LOD/water content and overage rules, then gates the weigh against tolerance in real time.
Electronic batch records that assemble themselves
Every scan, weight, signature, deviation and in-process result lands in the EBR as the line runs.
In-process QC and environmental checks inline
Sampling plans, IPC limits, room and equipment status all gate the next step instead of being reconciled later.
What goes wrong today3 common problems
ERP stops at the door of the suite
ERP knows what was planned and what was consumed. It cannot prove who weighed what, against which assay, on which scale, in which room.
Paper batch records delay release by weeks
QA reconstructs the batch after the fact from paper, spreadsheets and memory. Every gap is an investigation.
Potency and moisture corrections live in spreadsheets
Uncontrolled calculations for assay-adjusted charges are one of the fastest routes to a data-integrity observation.
Everything V5 does here5 capabilities
Assay-corrected dispensing at the scale
V5 computes the as-is charge from the COA assay, LOD/water content and overage rules, then gates the weigh against tolerance in real time.
Electronic batch records that assemble themselves
Every scan, weight, signature, deviation and in-process result lands in the EBR as the line runs. Review by exception, not page-turning.
In-process QC and environmental checks inline
Sampling plans, IPC limits, room and equipment status all gate the next step instead of being reconciled later.
Deviations, CAPA and change control connected
A failed check opens the deviation with the lot, step, equipment and operator already attached — and drives the CAPA to effectiveness closure.
Controls that support Part 11
Attributable, time-stamped, tamper-evident records. Enterprise includes IQ/OQ and validation support; validation decisions stay yours.
Standards referenced
- 21 CFR 210 / 211 (cGMP for finished pharmaceuticals)
- 21 CFR Part 11 (electronic records & signatures)
- EU GMP Annex 11 (computerised systems)
- ICH Q7 / Q9 / Q10
- GAMP 5 (2nd edition)
Common questions4 answers
- What is pharmaceutical manufacturing software?
- It is the execution layer between ERP and the floor: it dispenses to assay-corrected targets, enforces the master batch record step by step, captures in-process results and signatures, raises deviations at the point of failure, and produces an electronic batch record with audit trail and e-signatures for QA review; people decide release.
- Does it replace our ERP?
- No. ERP remains the system of planning, purchasing and finance. V5 executes and proves what actually happened on the floor, then posts consumption, yield and lot genealogy back to ERP.
- Is V5 validated for GMP use?
- V5 supplies the product controls and records; you decide intended use, validation approach, approval and release. Enterprise includes IQ/OQ and validation support.
- How are potency and moisture corrections handled?
- Correction factors are derived from the COA assay and LOD/Karl Fischer result and applied to the theoretical charge automatically, with the calculation, inputs and version recorded in the batch record.