Most manufacturing quality programmes rely on inspection at the end of the production process rather than control throughout it. Non-conformances are discovered after the product is complete. CAPA records are maintained in spreadsheets. Audit preparation requires assembling documentation manually. Supplier quality data exists in separate systems disconnected from production. Perimattic builds custom quality management systems that integrate quality checkpoints into production workflows, automate non-conformance routing and CAPA tracking, and produce the compliance evidence that regulatory audits require — without manual assembly.
QMS Technology Stack — Node.js, Python, PostgreSQL, React, TypeScript, Docker, AWS, Kafka, REST APIs, GraphQL, Redis, Elasticsearch
Quality management system development is the design, engineering, integration, and support of software platforms that manage and automate quality processes across manufacturing and regulated industry operations. A custom QMS manages the full quality workflow — incoming inspection and goods receipt quality checks, in-process quality control with defect recording and disposition, non-conformance management, corrective and preventive action tracking, audit management, controlled document management, supplier quality management, and compliance reporting — and connects these quality processes to the production, inventory, and ERP systems where quality decisions have operational and financial consequences. Unlike off-the-shelf QMS products, a custom quality management system is built around the specific quality workflows, regulatory obligations, and integration requirements of the organisation rather than requiring the quality function to adapt its processes to a packaged product's model.
The challenge with most manufacturing quality programmes is that quality data is fragmented across systems that are not connected to each other or to production. Non-conformances are recorded in spreadsheets that are not linked to the production batch or work order that generated them. CAPA actions are tracked in documents that do not enforce due dates or verify effectiveness. Audit preparation requires manually assembling records from multiple systems before an inspector arrives. Supplier quality non-conformances are managed through email with no systematic tracking of corrective action status. The result is a quality management programme that documents quality events without controlling them — and produces compliance evidence at audit time through manual effort rather than capturing it continuously through the quality workflow.
Perimattic builds custom quality management systems that start from the actual quality workflows, regulatory requirements, and audit obligations of the organisation before any platform architecture decisions are made. Every engagement begins with a discovery phase that maps existing quality processes, compliance requirements, and integration dependencies. We design compliance evidence capture into every workflow from the start so that the records required at a regulatory inspection exist in the QMS continuously. We build the integration layer that connects quality events to production work orders, inventory positions, and ERP financial records. And we deliver in phases, testing each quality module against real operational scenarios and regulatory audit simulations before production deployment.
Non-conformance tracking
Spreadsheet records requiring manual routing to quality and engineering teams — non-conformances are not linked to the production batch or work order that generated them
Non-conformance tracking
Automated NCR workflows with configurable escalation and disposition routing — non-conformances are connected to the production event, batch, and supplier shipment that generated them
CAPA management
CAPA actions tracked in separate documents without due date enforcement, effectiveness verification, or linkage to the non-conformance that initiated the corrective action
CAPA management
CAPA workflow with root cause analysis tools, action assignment with ownership and due dates, verification of implementation, and effectiveness review with audit trail
Audit preparation
Manual assembly of quality records from multiple systems before each regulatory audit — compliance evidence is created at audit time rather than captured continuously
Audit preparation
Audit-ready reports generated directly from QMS data with configurable evidence packs — compliance evidence exists in the platform continuously, not assembled before the audit
Supplier quality
Supplier non-conformances managed through email with no systematic tracking of corrective action status or supplier performance trends across time
Supplier quality
Supplier quality portal with NCR routing to suppliers, SCAR generation and response tracking, corrective action verification, and supplier performance scoring
Compliance evidence
Quality data assembled at audit time from spreadsheets, email records, and paper-based quality documents — creating significant audit preparation burden and compliance risk
Compliance evidence
Continuous compliance evidence captured in QMS throughout production — every quality decision, disposition, CAPA action, and document approval is recorded with a timestamped audit trail
The operational cost of a quality management programme that is not connected to production and cannot produce audit-ready compliance evidence becomes visible as audit preparation burden, regulatory findings, and the management time spent assembling quality records that a properly designed QMS would capture automatically.
Seven QMS capability areas covering the complete quality management operation — from custom platform development and non-conformance management through CAPA, audit management, document control, supplier quality, and production integration.
Bespoke quality management platforms covering the full quality workflow from incoming inspection through final release. Built around the specific quality processes, regulatory obligations, and integration requirements of the organisation — not around the feature set of a packaged QMS product that requires quality workflows to conform to its model.
NCR creation, disposition routing, quarantine management, material review board workflows, and regulatory reporting. Non-conformances are connected to the production event, batch, or supplier shipment that generated them, and routed automatically to the correct quality, engineering, or supplier management workflow based on configurable escalation rules.
Corrective and preventive action workflows covering root cause analysis tools, action assignment with ownership and due dates, verification of implementation, and effectiveness review to confirm that the corrective action has resolved the underlying cause. CAPA records capture the full audit trail required by ISO 9001, IATF 16949, ISO 13485, and FDA regulatory frameworks.
Internal and external audit planning, audit finding management, evidence collection, and compliance status dashboards. Audit reports are generated directly from QMS data rather than assembled manually, so the compliance evidence required at a regulatory inspection exists in the platform continuously rather than being created at audit time.
Controlled document management with version control, approval workflows, and distribution with read-confirmation tracking. Change management workflows route document changes through the correct review and approval process, and distribution controls ensure that only the current approved version is accessible to production and quality personnel.
Supplier audits, supplier corrective action requests, incoming inspection management, and supplier performance scoring. Non-conformances on incoming material are routed to the supplier with structured response requirements, and supplier performance data is calculated from NCR volumes, SCAR response times, and incoming inspection results — accessible to procurement and quality management in a single platform.
Integration with MES, ERP, and laboratory systems connecting quality events to production records, inventory movements, and financial systems. Non-conformances are linked to the production work order and batch that generated them. Quarantine and scrap decisions are reflected in ERP stock positions. Quality data is not isolated in the QMS — it is connected to the operational systems where quality decisions have financial and operational consequences.
A structured six-stage process from free quality operations discovery through production deployment and ongoing platform support.
We map your existing quality processes, regulatory requirements, current non-conformance volumes, integration landscape, and compliance obligations. This free session produces a clear picture of current-state quality workflows and system dependencies before any QMS architecture decisions are made.
We document target quality workflows in detail — non-conformance management, CAPA, audit management, document control, supplier quality — and identify compliance requirements, integration points with production and ERP systems, and the regulatory evidence that must be captured continuously.
We design the QMS platform architecture and build a proof of concept against the highest-risk component — typically CAPA or audit management — to validate the approach and surface any technical or integration risks before full development investment begins.
We build QMS modules incrementally and integrate with MES, ERP, and supplier systems throughout development. Working quality workflows are delivered at each phase so progress can be validated against real quality scenarios and compliance requirements.
We test the QMS against real quality scenarios including regulatory audit simulations, edge cases in NCR and CAPA workflows, and integration failure modes. Quality team acceptance testing is completed before any production go-live.
We deploy to production with CI/CD pipelines, infrastructure monitoring, and operational runbook documentation. We provide training for quality teams and offer engineering retainers for ongoing QMS evolution, compliance requirement changes, and new quality module development.
We map your existing quality processes, regulatory requirements, current non-conformance volumes, integration landscape, and compliance obligations. This free session produces a clear picture of current-state quality workflows and system dependencies before any QMS architecture decisions are made.
We document target quality workflows in detail — non-conformance management, CAPA, audit management, document control, supplier quality — and identify compliance requirements, integration points with production and ERP systems, and the regulatory evidence that must be captured continuously.
We design the QMS platform architecture and build a proof of concept against the highest-risk component — typically CAPA or audit management — to validate the approach and surface any technical or integration risks before full development investment begins.
We build QMS modules incrementally and integrate with MES, ERP, and supplier systems throughout development. Working quality workflows are delivered at each phase so progress can be validated against real quality scenarios and compliance requirements.
We test the QMS against real quality scenarios including regulatory audit simulations, edge cases in NCR and CAPA workflows, and integration failure modes. Quality team acceptance testing is completed before any production go-live.
We deploy to production with CI/CD pipelines, infrastructure monitoring, and operational runbook documentation. We provide training for quality teams and offer engineering retainers for ongoing QMS evolution, compliance requirement changes, and new quality module development.
Select a sector to see how we design, build, and integrate quality management systems for regulated manufacturing environments.
Automotive suppliers operating under IATF 16949 require QMS platforms that manage APQP workflows, PPAP documentation, customer-specific non-conformance reporting, and supplier corrective action requests with full traceability from non-conformance through CAPA closure.
Automotive suppliers operating under IATF 16949 require QMS platforms that manage APQP workflows, PPAP documentation, customer-specific non-conformance reporting, and supplier corrective action requests with full traceability from non-conformance through CAPA closure.
Medical device manufacturers operating under ISO 13485 and FDA 21 CFR Part 820 require QMS platforms with electronic records, electronic signatures, validated document control, and audit trails that satisfy regulatory inspection requirements without manual assembly.
Aerospace manufacturers operating under AS9100 require QMS platforms that manage first article inspection, production part approval, non-conforming material disposition, and escape management with the traceability and audit evidence that customer and regulatory audits require.
Pharmaceutical manufacturers operating under GMP and FDA 21 CFR Part 211 require QMS platforms with validated electronic batch records, deviation management, out-of-specification investigation workflows, and audit-ready compliance evidence captured continuously rather than assembled at inspection time.
Food manufacturers operating under FSSC 22000, BRC, and retailer codes of practice require QMS platforms that manage HACCP deviation, supplier non-conformances, customer complaints, and audit management with the traceability that recall scenarios and regulatory inspections demand.
Electronics and contract manufacturers require QMS platforms that manage incoming component quality, in-process non-conformances, failure analysis, and customer return management across mixed-product production environments with multiple customer quality requirements.
Perimattic's work resulted in stable production systems. The team was helpful, easily accessible, and communicative through email. Their professionalism was impressive.
Quality
4.5
Schedule
5.0
Cost
5.0
Willing to Refer
4.5
DevOps Managed Services · Oct 2023 – Aug 2024
24/7 monitoring and support for production environments plus Linux server administration for a leasing automation company.
The new architecture is scalable and highly efficient, saving a lot of money in fees. Perimattic provides high-quality IT consulting and cloud development work promptly and at great value. The team remains involved from the planning stage to providing support, showing diligence and proactiveness.
Quality
5.0
Schedule
5.0
Cost
4.5
Willing to Refer
5.0
AWS Migration (Legacy → Microservices) · Nov 2018 – Ongoing
Transitioned a travel systems company's legacy server system to an AWS-based microservices architecture with ongoing maintenance.
Four structural advantages that separate quality management systems built for real regulatory environments from platforms that satisfy a demo but fail at a compliance inspection.
Every QMS engagement begins with a thorough mapping of actual quality workflows, compliance requirements, regulatory obligations, and audit evidence expectations before any platform decisions are made. This prevents the most common QMS failure mode: a technically functional platform that does not match the quality processes, regulatory requirements, or integration dependencies of the organisation it was built to serve.
Audit-ready compliance records are a design requirement, not an afterthought. We design every quality workflow — NCR, CAPA, audit management, document control — to capture the regulatory evidence that inspectors require as a byproduct of normal quality operations. Compliance evidence exists in the QMS continuously, not assembled in the days before a regulatory audit.
A QMS that holds quality records but is not connected to production and ERP systems cannot close the loop between a non-conformance and the production event that caused it, or between a scrap decision and the inventory position it affects. We design structured integration architectures that connect quality events to production work orders, inventory movements, and financial systems through maintainable interfaces with proper error handling.
The team that maps your quality workflows and designs the QMS architecture also builds, tests, and deploys it. There is no handoff between a consulting team and a delivery team, no loss of quality process context between discovery and implementation. You work with the same engineering team from the initial compliance review through production deployment and post-launch support.
“A quality management system that holds non-conformance records but cannot produce the compliance evidence required at a regulatory audit — or that is not connected to the production workflow where quality decisions need to be made — is a documentation tool, not a quality management system.”
Custom quality management system development is the design, engineering, integration, and ongoing support of software platforms that manage quality processes across manufacturing and regulated industry operations. A custom QMS manages the full quality workflow — incoming inspection, in-process quality checks, non-conformance recording and disposition, corrective and preventive action tracking, audit management, document control, and supplier quality management — and produces the compliance evidence required by regulatory frameworks such as ISO 9001, IATF 16949, ISO 13485, AS9100, and FDA regulations. Unlike off-the-shelf QMS products, a custom quality management system is engineered to the specific quality workflows, regulatory obligations, and integration requirements of the organisation rather than requiring the quality function to adapt its processes to a packaged product.
Off-the-shelf QMS platforms such as ETQ, MasterControl, and Veeva cover standard quality workflows and are well-suited to organisations whose processes fit the product's model. The limitations emerge when quality workflows are non-standard, when integration with MES, ERP, or laboratory systems needs to be deep and real-time rather than periodic, when regulatory requirements are specific enough to require configuration beyond what the product supports, or when the organisation's scale makes per-user licensing uneconomic. A custom QMS is also the right choice when existing packaged QMS products require significant customisation to match actual workflows — customisation that creates upgrade dependencies, support complexity, and ongoing vendor costs that exceed the cost of a custom platform. We help organisations evaluate this decision honestly during the discovery phase.
A custom QMS can manage the complete quality workflow: incoming inspection and goods receipt quality checks, in-process quality control with checkpoint recording and defect logging, non-conformance management with disposition workflows, material review board processes, and quarantine management; corrective and preventive action management with root cause analysis, action assignment, verification, and effectiveness review; internal and external audit planning, audit finding management, and evidence collection; controlled document management with version control, approval workflows, and read-confirmation distribution; supplier quality management including supplier audits, supplier corrective action requests, and supplier performance scoring; and compliance reporting and dashboards that present quality status and compliance evidence for management review and regulatory audit. The scope is determined by the specific quality processes discovered during the engagement.
Regulatory compliance in a QMS is not a feature to be added after the platform is built — it is a design requirement that shapes the architecture from the start. For ISO 9001 and IATF 16949, this means non-conformance management with documented disposition, CAPA with root cause analysis and effectiveness verification, internal audit management, controlled document management, and management review data. For FDA 21 CFR Part 11, it means electronic records with integrity controls, electronic signatures with identity verification, audit trail records for all quality events, and validated system operation. For ISO 13485, it means design history file linkage, risk management integration, and post-market surveillance data capture. We design compliance evidence capture into every workflow so that the records required at a regulatory audit exist in the QMS continuously, not assembled manually when an audit is announced.
Yes. Integration with MES, ERP, and laboratory systems is a core component of most QMS development engagements. We design and build structured integration layers — using REST APIs, event-driven messaging, and middleware — that connect the QMS with SAP, Oracle, Microsoft Dynamics, and custom MES platforms. The integration typically covers production work order linkage so that non-conformances are connected to the production event that generated them, inventory movements so that quarantined or scrapped material is reflected in ERP stock positions, and supplier data so that supplier non-conformances reference the purchase order and incoming shipment. We always begin with a thorough discovery of the existing integration landscape before designing the target architecture.
Supplier quality management in a custom QMS covers the full supplier quality workflow: incoming inspection management where supplier shipments are inspected against specification and non-conformances are recorded against the supplier and purchase order; supplier corrective action request (SCAR) generation and routing to the supplier with structured root cause and corrective action response requirements; supplier response tracking with acceptance or rejection of proposed actions and verification of implemented corrections; supplier performance scoring calculated from non-conformance volumes, SCAR response times, and on-time delivery data; and supplier audit management covering planned audit schedules, audit finding management, and re-qualification workflows. The supplier quality portal can be made accessible to suppliers directly so that SCAR responses and action updates are captured in the QMS rather than managed through email.
Document control in a custom QMS covers the complete controlled document lifecycle: document creation with author and reviewer workflows, version control that maintains document history and prevents unauthorised changes, approval workflows routing documents to the correct approvers based on document type and impact level, controlled distribution that delivers the current approved version to relevant personnel and tracks read-confirmation, periodic review scheduling that flags documents approaching their review date, and obsolescence workflows that withdraw superseded documents from circulation and archive them with version history intact. The document control module is typically designed to meet the requirements of the organisation's regulatory framework — ISO 9001, IATF 16949, ISO 13485, or FDA 21 CFR Part 11 — from the start rather than being configured to compliance after the fact.
A corrective action addresses a non-conformance that has already occurred — it investigates the root cause of an actual quality failure and implements actions to prevent recurrence. A preventive action addresses a potential non-conformance that has not yet occurred — it identifies a risk or systemic weakness and implements actions to prevent the failure from happening. In a well-designed QMS, both are managed through the same CAPA workflow structure: root cause analysis, action assignment with ownership and due dates, implementation verification, and effectiveness review to confirm that the action has resolved the underlying cause. The distinction matters for regulatory compliance because ISO 9001, IATF 16949, and other standards require evidence that the organisation manages both actual and potential non-conformances systematically. A custom QMS can be designed to capture and report both CA and PA activity separately for management review and regulatory audit purposes.
Audit management in a custom QMS covers the complete audit lifecycle: audit planning with schedule management, audit scope definition, and auditor assignment; audit execution support with checklist management, finding recording, and evidence attachment; finding management with severity classification, corrective action linkage, and due date tracking; audit report generation producing audit evidence packs directly from QMS data rather than requiring manual assembly; and audit programme management with trend analysis across audit cycles to identify systemic quality issues. For external regulatory audits, the QMS provides the compliance evidence — non-conformance records, CAPA histories, document approval records, management review minutes — in a structured, audit-ready format. The value of a well-designed QMS at a regulatory audit is that the inspector can be shown continuous compliance evidence rather than records assembled in the days before the audit.
We follow a structured six-stage process: a free discovery and scoping session to map your existing quality processes, regulatory requirements, non-conformance volumes, integration landscape, and compliance obligations; a process mapping and regulatory audit phase that documents current and target state quality workflows in detail; a QMS architecture and proof-of-concept phase that validates the approach against the most complex workflow before full development begins — typically CAPA or audit management; platform development and integration where we build QMS modules and integrate with MES, ERP, and supplier systems; testing, validation, and quality team acceptance testing against real quality scenarios including regulatory audit simulations; and deployment with monitoring, training for quality teams, and engineering retainers for ongoing QMS evolution. We deliver working software at each phase so you can validate progress against your quality and compliance requirements throughout the engagement.
Tell us about your quality operations — the regulatory requirements you work under, the non-conformance volumes you manage, the audit preparation burden your team carries, and the integration dependencies between quality and production. We will show you exactly how a custom QMS platform can replace manual quality management with automated workflows that produce compliance evidence as a byproduct of normal quality operations.