Quality Management Systems (QMS)

A Quality Management System (QMS) provides airtight validation of your product testing requirements, protecting both your business and your customers.

Benefits of Using QMS

1. Permanent Recordkeeping: Test results can be securely archived and accessed indefinitely.

2. Regulatory Compliance: Meets all industry and government testing standards and requirements.

Who Uses QMS?

• Pharmaceutical Manufacturers

• Health Product Manufacturers

• Chemical Manufacturers

• Food & Beverage Producers

• Government Contractors
  …and many others.

What Does a Typical QMS Engagement Look Like?

A consulting engagement for implementing a Quality Management System (QMS) in Infor LX is a structured project that follows a phased, methodical approach. The goal is to ensure full alignment with business objectives, seamless integration with existing ERP processes, and sustainable quality control practices. The engagement extends well beyond software configuration—encompassing process re-engineering, training, and continuous improvement.

Phase 1: Initiation and Planning

The first phase establishes the foundation for a successful project by defining objectives, scope, and team responsibilities.

Key Activities:

• Initial Meetings: Engage with leadership and stakeholders to define goals and secure executive commitment.

• Scope Definition: Identify which business areas (e.g., manufacturing, supply chain, procurement) and quality processes (e.g., non-conformities, CAPA, audits) are included.

• Gap Analysis: Compare existing practices to desired QMS standards (e.g., ISO 9001) to identify areas for improvement.

• Project Planning: Develop a comprehensive plan outlining timelines, milestones, responsibilities, and communication protocols.

• System Access: Establish consultant access to Infor LX, ideally within a mirrored test environment.

Phase 2: Design and Build

This phase focuses on designing optimized processes and configuring the Infor LX QMS module to support them.

Key Activities:

• Process Mapping and Optimization: Document current workflows, identify inefficiencies, and integrate quality management into daily operations.

• Technical Specification: Define system enhancements, interfaces, and data conversion requirements.

• System Configuration: Set up quality plans, test templates, specifications, and approval workflows.

• Coding and Unit Testing: Develop required enhancements and validate functionality through structured testing.

• Documentation: Produce user guides, work instructions, and an official quality manual.

Phase 3: Deployment and Testing

Testing and organizational readiness are the focus as the system nears launch.

Key Activities:

• Conference Room Pilot (CRP) / System Testing: Validate functionality and data integrity through controlled test scenarios.

• User Acceptance Testing (UAT): Engage key users to confirm the system meets operational requirements.

• Data Migration: Plan and execute the migration of existing quality data into Infor LX QMS.

• Training: Deliver targeted training sessions for end-users and internal trainers.

• Go-Live Planning: Prepare a detailed cutover and risk management plan to ensure a smooth transition.

Phase 4: Go-Live and Optimization

Once live, attention shifts to stabilization, performance tracking, and continuous improvement.

Key Activities:

• Go-Live Execution: Deploy QMS into daily operations.

• Post-Go-Live Support: Provide immediate issue resolution and fine-tuning assistance.

• Internal Audits and Management Review: Establish periodic assessments to ensure ongoing compliance and effectiveness.

• Continuous Improvement: Use metrics such as defect rates, audit outcomes, and CAPA success to drive enhancements.

• Certification (Optional): Support preparation for ISO 9001 or other certifications by coordinating with external auditors and resolving any non-conformities.

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George MorosesGeorge Moroses

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