Quality Control · In-Process · Release
Quality control software that records checks at the step, before final release.
In-process checks, sampling plans, spec limits, SPC trending, CoA generation and hold/release — enforced at the kiosk while the batch is still running, with a hash-chained audit trail behind every result.
In-process checks at the step
Spec limits and OOS routing
Sampling plans
SPC and capability
Full product detailCommon problems, what's included, why teams choose it, and where commercial meets regulated.
You searched 'quality control software' because QC still lives on clipboards.
In-process checks recorded on paper and typed up hours later
Out-of-spec results discovered at final release, after the value is added
Sampling plans that depend on whoever is on shift
CoAs assembled by hand in Word from three systems
No trending — you find the drift after the third failed batch
Hold and release status tracked with tape and hope
What quality control looks like when the system enforces it.
In-process checks at the step
The operator cannot advance the batch until the result is entered, in-spec or formally deviated.
Spec limits and OOS routing
Target, action and spec limits per attribute.
Sampling plans
AQL, ANSI/ASQ Z1.4 and fixed-n plans applied by product and risk — sample counts calculated, not remembered.
SPC and capability
Control charts, Cp / Cpk / Ppk and drift detection across batches, lines and sites — visible before the failure.
CoA generation
Certificates of Analysis built from the actual result records, signed, versioned and re-issuable with full lineage.
Hold / release control
Quarantine, restricted release and QA disposition enforced in inventory — held material physically cannot be consumed.
What changes when QC moves off the clipboard.
- Out-of-spec results surface within seconds of the check, not at release
- CoA turnaround falls from hours to a click
- Trending shows drift a batch or two before it becomes a rejection
- Released product is provably tested — every result linked to the lot
Standards your QC evidence maps to.
21 CFR 211.160 / 211.165
Laboratory controls and testing of every batch prior to release — specifications, sampling plans and results held as evidenced records.
21 CFR 211.192
Investigation of any unexplained discrepancy or out-of-specification result, with disposition and rationale recorded.
ISO 9001:2015 (8.6, 9.1)
Release of products and services, and monitoring, measurement, analysis and evaluation — with objective evidence.
ISO 13485:2016 (8.2.6)
Monitoring and measurement of product, including the identity of the person authorising release.
21 CFR Part 11
Bound e-signatures on results and dispositions, hash-chained audit trail, author-cannot-self-approve enforcement.
Quality control software for manufacturing, answered.
Is this a LIMS?
It overlaps but is not identical. V5 covers in-process and release QC — checks, specs, sampling, results, CoA and hold/release. A full LIMS adds lab-bench workflow such as instrument scheduling, stability studies and reference standards. V5 also has a LIMS module, and both share the same audit trail.
Can operators enter QC results at the line?
Yes — that is the point. Checks appear in the batch flow at the kiosk, and the step will not advance until the result is captured or a deviation is raised.
Does V5 do SPC?
Yes.
How does hold and release work?
QA disposition drives inventory status. Held or quarantined material is not selectable for dispense or shipping — the enforcement is in the system, not in a label.
Capabilities vary by plan and setup. Confirm specifics with our team before relying on them.
Find the out-of-spec while you can still do something about it.
Free trial. In-process QC, SPC and CoA in one system. IQ/OQ and validation support with Enterprise.