Quality Management and Compliance in Ostendo Continuum ERP

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Building Quality and Compliance Into Every Process

Ostendo Continuum ERP delivers an integrated, end-to-end Quality Management and Compliance framework, embedding traceability, control, documentation, and auditability directly into daily operations. Modern manufacturing, distribution, and service organisations face increasing demands for regulatory compliance, product traceability, and auditable quality processes.

Designed for manufacturing, food & beverage, pharmaceuticals, medical devices, electronics, distributors, service providers, and regulated supply chains, Ostendo enables organisations to meet ISO, GMP, HACCP, regulatory, and customer-specific requirements without relying on disconnected systems or manual paperwork.

Built-In Quality Management Framework

Ostendo Continuum provides a comprehensive set of Quality Management System (QMS) capabilities designed to support ISO-aligned practices, GMP environments, and customer-specific compliance requirements.

Key capabilities include:

Inventory traceability by batch number, serial number, expiry date, and revision
Mandatory QC approval workflows before inventory can be used or shipped
Quarantine locations for non-conforming or pending-inspection stock
Batch-level QC status with full change-log audit history
Capture of QC test results, measurements, and inspection data
Linked documents, images, and certificates stored directly against batches and transactions
Market and certification codes to control where products can be legally supplied

This ensures that only compliant, approved product is released into manufacturing or supplied to customers.

End-to-End Traceability for Compliance & Recalls

Ostendo provides full forward and backward traceability, answering the critical compliance questions:

Where did this product come from?
What components were used?
Which customers received affected stock?
Which batches, serials, or revisions are impacted?

Supported Tracking Dimensions

Serial Number tracking (unit-level traceability)
Batch / Lot tracking
Expiry date control
Revision tracking
Colour, grade, and size attributes

Tracking methods can be used individually or in combination, allowing different products to follow different compliance rules within the same system.

Every inventory movement is recorded with complete transaction history and drill-down to source documents, supporting rapid quality investigations, audits, and recall management.

Quality Embedded in Manufacturing Operations

Quality is enforced directly within manufacturing workflows using digital work instructions, routings, and checklists.

Key manufacturing quality features include:

QC checkpoints embedded into Bills of Material and routing steps
Digital Standard Operating Procedures (SOPs)
Hazard alerts displayed at operation level
Input/output batch and serial linking for full production traceability
Electronic documentation and image capture at each production stage
Unlimited, date-stamped production history notes

This approach builds quality into the process, reducing reliance on end-of-line inspection alone.

Batch Control, QC Status & Audit Trails

Ostendo’s Batch Management capability forms the backbone of quality enforcement:

Batch QC statuses: Approved, On Hold, QC Required, Rejected
Full status change history with user, date, and reason
Date of manufacture and expiry tracking
Supplier batch number capture
Quarantine locations for restricted stock
Linked documents, test results, notes, and images

Only approved batches can be issued, shipped, or consumed in manufacturing—ensuring compliance is enforced systemically, not manually.

Market Codes & Compliance by Destination

Ostendo allows Market Codes to be assigned to batches and customers, ensuring that:

Only compliant batches are supplied to specific markets (e.g. EU-certified, country-specific, customer-mandated standards)
Regulatory and contractual requirements are enforced automatically
Customer eligibility rules are applied at the point of dispatch

This is especially valuable for exporters, multi-jurisdiction manufacturers, and certification-driven industries.

Integrated Quality Control & Non-Conformance Management

Ostendo supports active quality management, not just passive record-keeping:

QC checks required before item release
QC test results and measurements linked to batches and work orders
Incident management for:
- Non-Conformances
- Corrective & Preventive Actions (CAPA)
- Return Merchandise Authorisations (RMA)
- Engineering Change Management
- Incident and near-miss reporting
Classification and trend analysis for continuous improvement

All records are date-stamped, traceable, and auditable, supporting both internal reviews and external audits. Issues are classified, tracked, and analysed, enabling trend reporting and continuous improvement across quality, safety, and operations.

Paperless Manufacturing & Controlled Work Instructions

Ostendo’s Order Process Traveler replaces paper-based work orders with an interactive, digital experience:

Step-by-step assembly instructions
Embedded health, safety, and quality checkpoints
Mandatory confirmations for critical steps
Real-time progress visibility
Linked BOMs, documents, and images

Quality is built into the process, reducing reliance on end-of-line inspection and improving first-pass yield.

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Mobile Quality & Compliance with Ostendo Freeway

Ostendo Freeway extends Quality Management and Compliance to the factory floor, warehouse, and field using Android and iOS devices.

Using configurable mobile datasheets and conditional checklists, organisations can:

Perform QC inspections on receipts, production steps, installations, or jobs
Capture measurements, temperatures, quantities, and reject counts
Update batch QC status in real time (subject to permissions)
Capture photos, annotations, voice notes, and signatures
Scan barcodes and RFID tags for fast, accurate data entry
Work offline with automatic synchronisation when connectivity is restored

Conditional checklists dynamically adapt based on responses, ensuring the right checks are performed at the right time, with clear pass/fail outcomes.

Statistical Quality Data & Continuous Improvement

Ostendo enables structured capture of quality metrics and operational statistics, including:

Reject quantities and defect rates
Temperature and measurement readings
Supplier quality performance
DIFOTIS (Delivery In Full, On Time, In Spec)
Manufacturing productivity and yield

Captured data can update item, supplier, customer, asset, and site statistics, supporting robust reporting and continuous improvement initiatives.

Compliance, Health & Safety Management

Ostendo Continuum also provides a robust Compliance and Health & Safety framework, ensuring operational risks are identified, controlled, and auditable.

Capabilities include:

Tracking employee qualifications, licences, and expiries
Asset certifications and capability matching
Scheduling restrictions where required capabilities are missing
Hazard registers across inventory, manufacturing, jobs, and customer sites
Risk-rated hazard listings (Extreme to Low)
Digital inductions, pre-start checks, inspections, and safety plans
Incident, investigation, and risk assessment records
Full document and image library linked to any record

All compliance activities are supported by date-stamped history notes and audit trails, providing defensible evidence for regulators and customers.

A Unified Quality & Compliance Platform

By integrating traceability, quality control, documentation, mobility, and reporting into a single ERP environment, Ostendo Continuum delivers:

Stronger regulatory compliance
Reduced risk and recall exposure
Improved product quality
Faster investigations and audits
Lower administrative overhead
Greater customer confidence
Improved product quality and customer confidence
A scalable platform that grows with your business

Quality is not an afterthought—it is embedded into every transaction.

Ready to Strengthen Your Quality & Compliance Framework?

Ostendo Continuum ERP can be configured to match your industry regulations, customer standards, and internal quality systems, from simple batch control through to enterprise-grade quality management.

Reporting & Analysis

Effective quality and compliance management depends on clear, timely, and auditable information. Modern ERP-driven reporting brings all quality data together, transforming inspections, non-conformances, audits, and corrective actions into real-time insights that support continuous improvement and regulatory confidence.

Centralised Quality Intelligence

Quality and compliance reporting consolidates data from across operations into a single source of truth, giving managers, auditors, and quality teams immediate visibility into:

Inspection and test results
Non-conformance trends
Corrective and Preventive Actions (CAPA) status
Supplier quality performance
Audit findings and follow-ups

This eliminates spreadsheet silos and manual reporting, ensuring accuracy and consistency.

Real-Time Dashboards & KPIs

Interactive dashboards provide at-a-glance visibility of key quality indicators, such as:

First-pass yield and defect rates
Open vs closed non-conformances
CAPA ageing and effectiveness
Audit compliance status
Supplier rejection and return rates

These dashboards can be filtered by product, customer, supplier, site, or time period, enabling fast root-cause analysis and informed decision-making.

Full Traceability & Audit Readiness

Quality reporting delivers end-to-end traceability, linking:

Materials and suppliers
Production batches and serial numbers
Inspection results and deviations
Corrective actions and approvals

Complete audit trails ensure every change, decision, and approval is time-stamped and traceable—supporting ISO standards, GMP requirements, and customer audits with confidence.

Compliance Monitoring & Risk Management

Automated compliance reports highlight:

Overdue inspections or audits
Repeated or high-risk non-conformances
CAPAs at risk of breaching deadlines
Supplier or process performance deterioration

Early visibility enables proactive intervention, reducing compliance risk and avoiding costly failures or recalls.

Continuous Improvement & Management Reporting

Trend analysis and historical reporting support structured improvement initiatives by:

Identifying recurring quality issues
Measuring CAPA effectiveness over time
Comparing performance across sites or product lines
Providing executive-level summaries for management review

This data-driven approach aligns quality outcomes with broader business objectives.

Integrated, Reliable, and Actionable

Within Ostendo Continuum, quality and compliance reporting is fully integrated with manufacturing, inventory, purchasing, and jobs—ensuring quality data reflects real operational activity, not after-the-fact reporting.

The result: greater transparency, stronger compliance, faster audits, and a culture of continuous quality improvement—backed by trusted, real-time ERP intelligence.

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