Quality Systems Support
Quality systems programs don't fail because quality standards are unclear. They fail because QMS and execution systems don't communicate, quality events delay shipments without visibility, and CAPA workflows don't close the loop between quality and operations.
Quality management systems like TrackWise, MasterControl, and Sparta Systems are essential for compliance,
but they often operate in isolation from WMS, ERP, and execution systems. When a quality hold is placed,
when an NCR is opened, or when a CAPA investigation begins, operations must respond immediately. But if
those quality events don't sync across systems, inventory sits in quarantine indefinitely, shipments are
delayed, and audit trails break.
BaszGroup supports organizations through QMS integration, quality event workflow design, real-time visibility
implementation, and recovery when quality programs create operational chaos or compliance risk.
Core Quality Management Capabilities
Non-Conformance & CAPA
NCR workflows, corrective and preventive action tracking, root cause analysis, and effectiveness verification. Must integrate with inventory systems to trigger holds and releases.
Inspection & Testing
In-process inspection, receiving inspection, final release testing, certificate of analysis (CoA) management. Results must flow to WMS to enable or block inventory movement.
Document Control & Change Management
Controlled document versioning, change request workflows, approval routing, training record linkage. Changes to specifications or procedures must trigger updates in execution systems.
Audit Management
Internal audit scheduling, external audit preparation, finding tracking, and corrective action follow-up. Audit trail integrity across QMS and operational systems is critical.
Complaint Handling
Customer complaint intake, investigation workflows, trend analysis, and regulatory reporting. Must link back to lot traceability and potentially trigger recalls.
Supplier Quality Management
Supplier qualification, incoming inspection, performance scorecards, and non-conformance tracking. Quality issues must influence procurement decisions and receiving workflows.
Industry-Specific Quality Requirements
Medical & Pharmaceutical
FDA 21 CFR Part 11 compliance, ISO 13485, GMP requirements, lot traceability, and validation documentation. Quality systems are mission-critical and heavily integrated with Commercial and distribution.
Learn more about Regulated programs →Food & Beverage
FSMA compliance, HACCP programs, allergen control, GFSI standards, and supplier verification. Quality holds for shelf life and temperature excursions must integrate with WMS and transportation.
Learn more about Food programs →Aerospace & Defense
AS9100 certification, PPAP requirements, first article inspection, and strict traceability. Quality documentation must follow parts through Commercial and into service.
Learn more about Industrial programs →Industrial Commercial
ISO 9001 baseline, customer-specific quality requirements, in-process inspection, and dimensional verification. Quality data must flow to production planning and shipping.
Learn more about Commercial programs →Where Quality Systems Programs Break
Quality holds and releases don't sync with execution systems
- Quality hold placed in QMS but WMS still allows picking and shipping
- Material released in QMS but remains blocked in ERP or WMS
- Partial lot holds (some lots OK, some quarantined) aren't granular enough in execution systems
- Hold status changes require manual data entry across multiple systems
- No real-time visibility into which inventory is on hold and why
NCR and CAPA workflows are disconnected from operations
- Non-conformances are documented in QMS but corrective actions in operations never happen
- CAPA investigations drag on while impacted inventory sits in limbo
- Disposition decisions (rework, scrap, use-as-is) aren't communicated to warehouse or production
- Root cause analysis doesn't trigger process changes in WMS or ERP
- Effectiveness verification isn't tied to operational metrics
Inspection results don't trigger automatic execution responses
- Receiving inspection pass/fail doesn't automatically release or reject inventory in WMS
- In-process inspection holds don't stop production or trigger rework workflows
- Certificate of Analysis (CoA) approval doesn't enable shipping
- Out-of-spec results require manual intervention to prevent distribution
- Inspection data lives in QMS but isn't visible to planners or warehouse operators
Audit trail fragmentation creates compliance risk
- Quality events documented in QMS, inventory transactions in ERP/WMS, with no linkage
- Lot traceability requires manual correlation across multiple systems
- Electronic signature and 21 CFR Part 11 compliance only enforced in QMS, not execution systems
- Change history and who-did-what-when isn't consistently captured
- Regulatory auditors struggle to reconstruct event sequences
Real-time quality visibility doesn't exist
- Operations can't see which inventory is awaiting quality clearance
- Planners don't know quality hold status when committing to customer orders
- Shipping teams discover quality blocks at the last minute
- Quality metrics (defect rates, CAPA cycle time) aren't visible to operations leadership
- Dashboard and reporting require manual data extraction from QMS
Quality program changes don't propagate to execution systems
- Specification changes in QMS don't trigger updates to receiving or inspection workflows
- New testing requirements aren't reflected in WMS or production systems
- Training completions in QMS don't update user permissions in operational systems
- Document revisions create version control issues across platforms
- Quality procedure changes require manual updates in multiple places
Quality Systems Creating Operational Bottlenecks?
If your QMS and execution systems aren't communicating, or quality events are delaying operations without visibility, we can help.
Measurable Success in Quality Systems Programs
- Quality holds sync in real time between QMS and execution systems
- Disposition decisions trigger automatic workflow changes in WMS/ERP
- Inspection pass/fail results enable or block inventory movement automatically
- CAPA cycle time decreases as operational feedback loops tighten
- Defect escape rate declines because quality gates are enforced systemically
- Shipment delays due to quality holds reduce significantly
- Audit trail integrity is maintained across QMS and execution systems
- Lot traceability is complete and accessible in seconds, not hours
- Regulatory audit findings related to system integration are eliminated
- Real-time quality dashboards provide visibility to operations and leadership
- Quality metrics drive operational improvement, not just compliance documentation
- Cross-functional collaboration between quality and operations strengthens
Where We Engage
We support quality systems programs from integration design through workflow optimization and compliance recovery. Our focus is connecting QMS to execution systems, designing quality event workflows that maintain operational flow, ensuring audit trail integrity, and enabling real-time visibility. We bridge quality and operations.
QMS Integration Design and Implementation
Integration architecture between QMS (TrackWise, MasterControl, Sparta) and ERP/WMS, quality hold and release workflows, inspection result automation, disposition decision routing, and audit trail design.
Quality Event Workflow Optimization
NCR and CAPA workflow design that connects to operations, hold and quarantine management, inspection and testing integration with receiving and production, and real-time visibility implementation.
Compliance and Audit Trail Assurance
21 CFR Part 11 compliance across integrated systems, lot traceability and recall readiness, audit trail integrity verification, regulatory audit preparation, and compliance gap remediation.
Program Recovery and Stabilization
For quality systems that are disconnected from operations or creating compliance risk. Root-cause assessment, integration corrections, workflow redesign, audit trail restoration, and sustained stabilization support.
Learn More About Our Quality Systems Services
Ready to Talk About Your Quality Systems Program?
Let's Connect Quality and Operations
Whether you're integrating a new QMS, struggling with quality event workflows, or recovering from compliance issues, we can help.