Can the QMS be configured to match our ISO 9001 or IATF 16949 clause structure?

Yes. We map the system modules to your certification clause structure during the requirements phase so the QMS reinforces your management system. For ISO 9001:2015, the document control, audit management, and CAPA modules satisfy the evidentiary requirements of clauses 7.5, 9.2, and 10.2. For IATF 16949, requirements around APQP, PPAP, MSA, SPC, and customer-specific requirements of OEMs are built in as configurable rule sets. The audit trail, record retention, and document control workflows are defined during requirements sign-off with your quality manager.

How does document control handle regulatory requirements for 21 CFR Part 11?

For FDA-regulated manufacturers, we build electronic signature and audit trail functionality that meets 21 CFR Part 11 requirements: tamper-evident time-stamped audit trails, individual user authentication with unique IDs for every approval action, and electronic signature attribution that binds the signature to the record version. We document the Part 11 assessment as part of the validation package, covering IQ, OQ, and PQ protocol structure agreed before development starts.

Can the QMS integrate with our existing ERP or MES?

Yes. Common integration points include pulling non-conformance triggers from an MES when a quality hold is placed, syncing part master and supplier master from the ERP, and pushing inventory quarantine flags back to the ERP. For SPC, the integration can pull measurement data directly from CMM output files or automated gauging systems. Integration capability depends on your ERP's API or file export options, which we assess during scoping.

How long does implementation typically take?

A QMS covering CAPA, document control, and audit management typically takes 14 to 18 weeks from requirements sign-off to go-live. Adding supplier quality with APQP/PPAP tracking and calibration management extends this by four to six weeks. Adding SPC adds two to four additional weeks. We stage the rollout by module so your quality team can start using CAPA and document control while other modules are still being configured.

QMS Software Development for Manufacturing

When CAPA lives in spreadsheets, your QMS is only as good as the last update

When CAPA actions live in spreadsheets and document versions travel by email, your quality system is only as reliable as the last person who remembered to update the file. An audit response that should take minutes takes a day because the records are spread across folders and inboxes. We build custom QMS software for manufacturers who need structured, auditable quality processes: CAPA and document control through supplier quality and SPC, built to hold up under an auditor's scrutiny.

CAPA management with root cause, action assignment, and effectiveness verification
Document control with version management, approval workflows, and controlled distribution
Audit management for internal, supplier, and customer audits with finding tracking
SPC charts and process monitoring with out-of-control alerts

Recent outcomes

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6× deeper insights

Text-based interviews converted to automated phone calls

AI Automation · Ops

20k+ txns day one

Manual invoice OCR across 40+ gas stations

Loyalty · Retail

1,062 users in 4 weeks

SuperValu & Centra loyalty platform with receipt validation

SaaS · Logistics

2,000+ shipments yr 1

Multi-carrier shipping hub for Indonesian eCommerce

4.9

on Clutch

See our work

The problem

Sound familiar?

CAPA actions tracked in spreadsheets with no systematic follow-up or closure verification?
Audit findings managed in a shared folder with no visibility on open versus closed items?

Short answer

A Quality Management System (QMS) is the software layer that manages non-conformances, corrective actions, document versions, audits, and supplier quality in a controlled, auditable way, replacing spreadsheet-based CAPA tracking and emailed PDFs with structured workflows and a single source of truth. RaftLabs builds custom QMS software for manufacturers aligned to ISO 9001, IATF 16949, and FDA 21 CFR Part 11 requirements, typically delivering in 14 to 18 weeks at a fixed cost.

Key takeaways

A custom QMS is built around your document hierarchy, audit schedule, and non-conformance categories - not a generic configuration with unused screens.
The CAPA-to-FMEA link recalculates the Risk Priority Number automatically, so effectiveness verification is measurable, not assumed.
We stage rollout by module - CAPA and document control go live first, supplier quality and SPC follow, so the system delivers value from week 14 onward.
Most QMS projects covering CAPA, document control, and audit management deliver in 14-18 weeks; supplier quality and SPC extend the timeline by 4-8 weeks.

Trusted by

QMS delivery, by the numbers

products shipped: 100+

industries served: 24+

cost delivery: Fixed

week delivery cycles: 12-14

Why custom QMS software outperforms generic platforms

Generic QMS platforms are built to cover every industry with a single configuration. The result is a system with screens and fields your team will never use sitting next to gaps that require workarounds for your specific process. Customisation options are limited by what the vendor has exposed, and you pay per user for features you don't use.

A custom QMS is built around your quality processes, your document hierarchy, your audit schedule, and your non-conformance categories. It fits the way your quality team actually works, which means adoption is faster and the data quality is higher. When an auditor arrives, you can pull the records they need in minutes rather than spending the morning reconstructing them.

Capabilities

What we build

01
CAPA and non-conformance management
Non-conformances captured at detection, whether on the line, in incoming inspection, or from a customer complaint, trigger a structured 8D CAPA workflow: containment, root cause with Ishikawa diagram support, corrective action with owner and due date, and effectiveness verification before closure. FMEA risk register integration recalculates the Risk Priority Number once the corrective action lands, confirming the risk has actually been addressed.
Built with
8D · Ishikawa · FMEA
02
Document control and approval workflows
Documents created, reviewed, and approved under an ISO 9001:2015 clause 7.5 compliant framework, with automatic version history and full audit trail. Controlled copies distribute electronically with read confirmation required. Training matrices link document revisions to personnel training records, flagging who needs retraining when a procedure changes. No more emailed PDFs with version numbers in filenames.
03
Audit management
Internal, supplier, and customer audits scheduled from a single calendar aligned to ISO 9001 or IATF 16949 requirements, with checklists structured by clause or process. Findings recorded on mobile with severity classification; findings above threshold auto-generate a linked CAPA record. Repeat-finding tracking flags processes where corrective actions haven't held, a key surveillance trigger for certification bodies.
04
Supplier quality management
Approved vendor list with classification, approval status, and rolling performance scores. APQP/PPAP documentation tracked per new part submission against customer-specific PPAP level requirements. Incoming inspection results tracked by supplier, part, and lot. Supplier corrective action requests follow the same CAPA structure, with 8D response required within a configurable window.
Built with
APQP · PPAP
05
Calibration management
Every gauge and instrument registered with calibration interval, owner, procedure, and traceability to the national measurement standard. Automated due-notices and overdue escalation. If an instrument comes back out of tolerance, the system flags every measurement taken since the last in-tolerance calibration for quarantine review, the required response under ISO 9001:2015 clause 7.1.5.2.
06
Statistical process control
Shewhart control charts for key process characteristics, fed by operator entry or direct CMM/gauging import. Charts evaluated in real time against the full set of Western Electric rules; violations trigger an immediate out-of-control alert linked to the relevant process FMEA. Cp/Cpk capability indices calculated continuously and formatted for PPAP submissions without manual charting in Excel.
Built with
Xbar-R · I-MR · WECO rules

How we work

From scope to live QMS

Week 1
01
Clause-structure and process scoping
We map your certification clause structure and current non-conformance/document/audit process. You leave week 1 with a written scope document and a fixed-price quote.
Weeks 2-4
02
Data model and validation planning
CAPA, document control, and audit workflows designed against your certification standard. For FDA-regulated manufacturers, IQ/OQ/PQ protocol structure agreed before build starts.
Weeks 5-14
03
Build and integrate
CAPA, document control, and audit management built first and staged live; supplier quality, calibration, and SPC follow in subsequent releases.
Final 2-4 weeks
04
Rollout and data migration
Existing CAPA records, calibration history, and approved vendor lists migrated as part of the project scope, not billed separately.

Why us

Why manufacturers choose RaftLabs

01
Senior engineers build what they scope
The engineers who assess your quality processes also build the solution. No bait-and-switch, no offshore handoff after the contract is signed.
02
Fixed price before development starts
We scope the work, calculate the cost, and lock it in writing before any development starts.
03
9 years and 100+ products shipped
Clients include Vodafone, T-Mobile, Aldi, Nike, Cisco, and Lockheed Martin. Track record building compliance and workflow systems for regulated manufacturers.
04
Built for the audit, not just the workflow
The certification body's requirements are a design input, not an afterthought. We've built QMS systems that have been through successful ISO 9001 and IATF 16949 surveillance audits.
05
Staged rollout, value from week 14
CAPA and document control go live first while supplier quality and SPC are still being configured, so your team isn't waiting for full scope to start using the system.

Have a QMS project?

Tell us about your quality processes and the certification standards you operate under. We'll scope a system that works for your auditors and your team.

Talk about your QMS project

Related services

Quality Management System Software Development, scoped in one call.

Tell us what's broken. Within one business day you get a straight take on cost, timeline, and the right first step. No deck, no pressure.

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: Yes. We map the system modules to your certification clause structure during the requirements phase so the QMS reinforces your management system. For ISO 9001:2015, the document control, audit management, and CAPA modules satisfy the evidentiary requirements of clauses 7.5, 9.2, and 10.2. For IATF 16949, requirements around APQP, PPAP, MSA, SPC, and customer-specific requirements of OEMs are built in as configurable rule sets. The audit trail, record retention, and document control workflows are defined during requirements sign-off with your quality manager.
: For FDA-regulated manufacturers, we build electronic signature and audit trail functionality that meets 21 CFR Part 11 requirements: tamper-evident time-stamped audit trails, individual user authentication with unique IDs for every approval action, and electronic signature attribution that binds the signature to the record version. We document the Part 11 assessment as part of the validation package, covering IQ, OQ, and PQ protocol structure agreed before development starts.
: Yes. Common integration points include pulling non-conformance triggers from an MES when a quality hold is placed, syncing part master and supplier master from the ERP, and pushing inventory quarantine flags back to the ERP. For SPC, the integration can pull measurement data directly from CMM output files or automated gauging systems. Integration capability depends on your ERP's API or file export options, which we assess during scoping.
: A QMS covering CAPA, document control, and audit management typically takes 14 to 18 weeks from requirements sign-off to go-live. Adding supplier quality with APQP/PPAP tracking and calibration management extends this by four to six weeks. Adding SPC adds two to four additional weeks. We stage the rollout by module so your quality team can start using CAPA and document control while other modules are still being configured.

Work with us

Tell us what you need. We'll tell you what it would take.

We scope Quality Management System Software Development in 30 minutes. You walk away with a clear cost, timeline, and approach. No commitment required.

Scope and cost agreed before work starts. No surprises. No obligation.
Working prototype within 3 weeks of kickoff.
Pay by milestone. You see progress before each invoice.
60-day post-launch warranty. Bug fixes, UI tweaks, and deployment support. No retainer.
All conversations are NDA-protected.

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Manufacturing software by area

01
Manufacturing industry hub
RaftLabs track record building software for manufacturers.