• Quality Management System

Build the gate. Kill the manual report.

CAPA that proves the fix, a full learning system, controlled documents in every module, 100+ release queues and a complete LIMS. Release-ready starts with the evidence already in place.

See how it works

Runs on its own. Connects when you’re ready.

Test in contextSample → method → result

LAB RESULTS · AR-0042

Sample linked to its lot

Approved method in use

Results in specification

Sample linkedMaterial and batch in context

Method approvedCurrent specification in use

Result recordedInstrument and analyst linked

Every test has its context.

Methods, results and investigations stay with the material or batch.

The problem

Quality finds out last.

The lab, the floor and the document room each keep their own records. QA is left assembling the story after the fact, and the audit becomes a project of its own.

• 01 · Root cause

Evidence lives in five places.

Lab results in one system, batch records on paper, SOPs in a shared drive, training in a spreadsheet. Every release decision starts with a search.

• 02 · Root cause

Closed is not the same as fixed.

A CAPA gets closed because the action was marked done. Nobody checks whether the same deviation is back, and nobody has checked whether the fix worked.

• 03 · The cost

Audit prep becomes a sprint.

Weeks before an inspection, the team drops quality work to pull records by hand. That is not readiness; it is a scramble for the last fortnight.

Quality that gates the work

Less evidence hunting.
More time for the quality decision.

01 / Built-in CAPA workflows

A CAPA is not closed because someone says it is.

Carry every quality event through investigation, corrective work and an effectiveness check, in one system. Change control maps the impact before anything moves.

01
Open from the event.
Raise deviations, change controls and CAPA from quality events, with their source context.
02
Investigate with history.
Start with the history for the same equipment, product and stage, and map each change’s impact on documents, training and masters.
03
Close on evidence.
Close CAPA only after a passed effectiveness check.

CAPA-0034 · Effectiveness check

Defects on the next 3 lots from Nilgiri Glassworks. Target under 0.1%. Before the CAPA: 0.8%.

Checking

LotReceivedRejectedRateResult

GRN-0016Awaiting lot—

GRN-0018Awaiting lot—

GRN-0021Awaiting lot—

Closing gate

Every action done3 of 3, each with its evidence

Every change control closedCC-0016, closed Nov 2

Effectiveness verifiedAll 3 lots under target. Average 0.03%, down from 0.8%.

Close CAPA

02 / A full learning system

Train new joiners, retrain on schedule, and keep everyone current.

A complete learning system, not a training register. Curricula on day one, retraining on schedule, and a competency matrix of who can do what.

01
Onboard by role.
New joiners get a role-based curriculum, assigned automatically.
02
Retrain on schedule.
Run periodic training and retrain on every SOP revision, with SOP reading, videos, timed quizzes and on-the-job assessments.
03
Gate work on competency.
Keep a competency matrix per person, and suspend access the moment training lapses.

03 / Controlled documents across every module

The right SOP, on the page where the work happens.

Write, review and revise SOPs in the app. The effective version appears inside every module that depends on it, from stores to the shop floor to the lab.

01
Write in the app.
Draft in an in-app editor with an outline, suggested edits and comments.
02
Check where it applies.
See everywhere an SOP applies before you change it.
03
Retrain on revision.
Assign training automatically when a new revision takes effect.

SOP-PRD-024 Coating preparationRev 4 draft

4. Procedure

4.1 Confirm line clearance LC1 is signed before charging the vessel.

4.2 Weigh the coating premix on a calibrated balance and record the net weight.

4.3 Add purified water at ~~25 to 30 °C~~20 to 25 °C and stir for not less than 45 min.

Kavya R. Matches the new premix supplier’s data sheet. Approve?

4.4 Record the stirring time and hand over to stage 7.2.

4.5 Filter the mix through a 60 mesh screen into the holding tank.

4.6 Use within 24 hours of preparation. Discard after that.

04 / 100+ release queues & approval conditions

Release on your conditions, not on someone’s memory.

Every release point has its own queue and conditions, from material to final batch. Set what must be true, and Factro holds the item until it is.

01
Set your conditions.
Configure approval conditions, control points and triggers across stores, production, lab and QA.
02
Release by exception.
Review only what needs attention, instead of the whole record.
03
Hold on open deviations.
Block batch release while a critical or major deviation remains open.

GRN-0421 · Filler MC-102 · Release conditions

Configured once, checked on every lot

Checking

Full testing on receipt, not reducedTesting · PO, vendor qualification

Retest before use if held over 90 daysTesting · GRN, PO

CoA with every lot, on the vendor letterheadDocuments · PO, vendor qualification

CoA on the new templateDocuments · PO

Close the open CAPA before the next orderVendor · Vendor qualification

Supply only from the audited siteVendor · Vendor qualification, PO

05 / A full LIMS, built in

Every result has a lab, an instrument and a standard behind it.

A full LIMS, not an add-on. Every sampling, IPQC and FPT result in ERP and MES carries the lab, instrument and standard that produced it.

01
Run the lab.
Run labs and instruments with their own layouts, schedules and upkeep, and block any instrument overdue for calibration or maintenance.
02
Watch your standards.
Track primary and working reference standards, and flag every test that depends on one before it expires.
03
Validate and report.
Keep a validation pack with every instrument, raise OOS straight into Quality events, and build CoAs from the results.

Reference standards

Primary from the issuing body, working qualified against them

IDSubstancePurityRetest byUsed inStatus

RS-BAS-0328Base material, workingWorking99.6%Oct 2444 testsQualified

RS-IMP-AImpurity AImpurity99.0%Oct 159 testsQualified

RS-BAS-P-01Base material, primaryPrimary100.0%Ref valid5 specsQualified

RS-FIL-0811Filler MC-102Working99.1%Nov 718 testsRetest due

RS-ADC-0412Additive CPrimary99.8%Ref valid11 testsLow stock

Under the hood

Everything QMS runs,
module by module.

The lab, the investigation, the procedure and the people. One quality system, with evidence at every step.

QMS

Quality assurance

Quality events, CAPA and release, each held until its conditions are met.

100+ Release Queues
Release by Exception
Deviation History
Effectiveness Gate
Live Compliance Score

QMS

Controlled documents

SOPs written and approved in the app, shown wherever they apply.

Library
Editor
Reviews
Revisions
Approvals

SOPs Across the Platform
Suggest Edits
Retraining on Revision
Periodic Review

QMS

Training

Courses, quizzes and a competency matrix that gates regulated work.

Courses
Assignments
Quizzes
On-the-job assessments
Competency matrix

Role-based Curriculum
Timed Quizzes
Competency Gates
Suspension on Lapse

QMS

Laboratory

A full LIMS: instruments, standards and validation behind every result.

Instrument Traceability
Reference Standard Expiry
Validation Packs
Calibration Lockout

Task Manager

Every task, approval and conversation, with nothing chased by hand.

Tasks
Alerts
Reminders
Conversations
Variance

Automatic Nudges
Approvals with SLA
Related Search

Library

Master data for every module, under change control.

Masters
Materials
Specifications
Test masters
Equipment templates

Version Control

Industry packs

Controls for each regulated category, on the same records and workflows.

Moments that matter

The days quality
is judged on.

Five situations every QA team meets. Here is what happens in Factro.

A new analyst joins on Monday.

Their role’s curriculum is assigned before they log in. SOPs to read, videos, timed quizzes and on-the-job assessments. They only get assigned work once the competency matrix shows them as trained.

The cleaning SOP is revised.

The revised version goes to every step the SOP governs. When the revision takes effect, retraining starts automatically, and the current instruction is already on the cleaning step.

A reference standard expires next week.

The lab sees it coming. Tests that depend on it are flagged, and results capture the approved standard on each record.

A batch is ready, but a major deviation is still open.

Release is blocked. The queue shows the open deviation and what remains to be done, not a separate inspection of the whole record.

An inspector asks for the CAPA history on Line 2.

The record opens straight from the search, with every deviation, investigation, action and effectiveness check linked. Nobody stops manufacturing to find it.

Who it is for

Built for the people who
sign off on quality.

Each role opens Factro on its own screen, with the evidence it needs to act.

01 / Who it is for

A sampling queue, results with instrument records, and OOS raised in place.

01
A sampling queue raised at receipt and on the floor
02
Results with lab and instrument records
03
OOS raised in place, CoA built from results

Before you start

Questions
plants ask us.

Start with the operation you have. Agree the controls and connections you need.

Talk to our team

What does a release queue check?

Whatever the step needs. Typical conditions include passed tests, closed deviations, effective documents, current training and independent QA approval. Each queue’s conditions are configured around your SOPs.

Do we need a separate LIMS?

No. It is built in. The Laboratory module is a full LIMS: labs, instruments, reference standards, validation packs and calibration, behind every sampling, IPQC and FPT result on the platform. Results stay with the material or batch they belong to.

Can QMS run if our batches are recorded somewhere else?

Yes. QMS runs on its own and can take batch and material data from your existing systems. You get the full benefit of release by exception once MES records sit on the same record.

What prevents a CAPA from closing too early?

The effectiveness check must pass and the configured approvals must be complete. Finishing the action alone does not close the corrective record.

Who makes the release decision?

An independent, authorised QA reviewer. Factro brings the evidence together and applies the checks; it never replaces the accountable human decision.

When do we start paying?

When you start using it. Start with your own records and processes during onboarding, before the subscription begins.

Make it your workflow

Bring a deviation.
Follow it to verified closure.

Walk through a CAPA, an SOP revision and the training it must raise, the lab and the release queue, on a quality workflow that matches your plant.

Walk through QMS