QMSQuality & Compliance
Quality Management System
Regulatory Compliance & Connected Quality Excellence Document control, CAPA, audits, training, risk management and full LIMS in one plant-floor-connected platform for regulatory compliance.
The challenge
Quality management in manufacturing has long been fragmented: document control sits in one system, CAPA tracking in another and lab results in spreadsheets, with no connection to the shop floor where quality events actually originate. This fragmentation creates blind spots, delays investigations and turns regulatory audits into resource-intensive exercises.
Overview
The LOGICAL SYSTEMS Quality Management System (QMS) unifies standard operating procedures, document control, change management, CAPA, audit management, training, non-conformance handling, complaint management, risk management and full Laboratory Information Management System (LIMS) capabilities in a single plant-floor-connected platform. Built on the Inductive Automation Ignition platform, it is natively integrated with real-time OPC UA tags, alarms and historian data: a temperature excursion auto-creates a deviation, an equipment alarm triggers a calibration check, and an out-of-range batch parameter initiates an out-of-specification (OOS) investigation.
Unlike cloud-only solutions that sit disconnected from manufacturing operations, QMS bridges the quality office, the production floor and the laboratory, turning reactive quality management into proactive, event-driven quality intelligence. It operates as part of a three-module ecosystem with the LSA Task Management System (TMS) and LSA Statistical Process Control (SPC): SPC out-of-control events auto-create QMS deviations, CAPA corrective actions become TMS tasks, and lab test results feed SPC control charts. Licensing is unlimited, with no per-user fees.
Capabilities
What QMS does
Document Control & Change Management
- Document lifecycle: Draft → In Review → Approved → Effective → Obsolete → Archived
- Sequential or parallel approval routing with electronic signatures and distribution tracking
- Change requests with impact analysis and change order execution
Deviations & CAPA
- Deviation workflow with classification, severity grading, MRB review and disposition
- CAPA stages: open, investigation, root cause, assignment, action plan, implementation, verification, closure
- Root cause tools: 5-Why, Ishikawa/Fishbone, Fault Tree and Pareto
- Effectiveness verification with recurrence monitoring
Audit Management
- Audit programmes across ISO 9001, ISO 22000 and other configurable standards
- Configurable checklists with compliance scoring and finding classification
- Finding-to-CAPA linkage for internal, external, supplier, regulatory and customer audits
Training & Competency
- Training plans by role, department or document: classroom, video, assessment, mentoring
- Competency matrix of skill by person by proficiency, with certification and expiry tracking
- Online assessments with automatic certification and auto-retraining on document revision
LIMS & Sample Testing
- Sample lifecycle management with chain of custody
- Specifications with test methods, acceptance criteria (USL/LSL) and SPC integration
- OOS investigation: Phase I (lab) and Phase II (full), with retest authorisation
- Equipment calibration (time, usage or event-based) and IQ/OQ/PQ qualification
Integration & Intelligence
- SPC out-of-control events auto-create deviations; CAPA actions sync bidirectionally with LSA TMS
- Tag-, alarm- and SPC-driven automation rules create deviations and notifications
- ICH-compliant stability studies; cleanroom monitoring with ISO/GMP classification and excursion management
- Batch release with record review, sample aggregation and CoA/CoC generation
- Supplier qualification workflows, supplier CAPA tracking, scorecards and incoming inspection
- Risk register with 5×5 matrix, FMEA with RPN, and HACCP with CCP monitoring
Benefits
Why manufacturers choose QMS
One platform, no gaps
Quality management and laboratory operations run on one platform, with no integration gaps.
Faster non-conformance resolution
Structured workflows speed up the resolution of non-conformances.
Improved CAPA closure
Automated escalation improves the closure of corrective and preventive actions.
Audit-ready compliance
Centralised documentation speeds up audit preparation, with audit-ready compliance across multiple standards.
Training compliance
Training is assigned automatically whenever a document is revised, supporting training compliance.
Stronger supplier quality
Supplier scorecards and qualification strengthen supplier quality.
Having QMS, LIMS, and SPC connected to our plant floor in one platform changed how we manage quality.
Ask QMS in plain language
LS Assistant, the AI assistant in every Logical Systems application, answers questions from your live QMS records and shows the sources behind every answer. It keeps learning as your records, work instructions and resolved issues grow, and your data is never used to train AI models.
Answers with sources
Every answer cites the records and work instructions it used.
Your role, your site
It sees only what each user is allowed to see.
Asks before it acts
Every change it proposes needs a person's confirmation and is audited.
18 languages, voice on mobile
Questions, answers and content in your teams' languages.
Integration
Connects to the systems you run
Systems & protocols
- OPC UA
- Historian
- MQTT
- OPC DA
- REST API (JSON payloads)
- Kafka (via connector)
- Snowflake (via pipeline, data bridge)
Standards
- ISO 9001
- ISO 22000
- 21 CFR Part 11
- ICH
- GMP
- HACCP
- ALCOA+
Datasheet
Quality Management System datasheetWorks with
Related solutions
See QMS in action
Book a demo with our engineers, using scenarios from your own plant.