Quality is often viewed as a necessary burden for a regulated company. Done right, Quality is the difference between success and failure of a medical product company. Do Quality Right with LuminLogic. Use LuminLogic to create compliant, consistent and efficient processes and accurate, reproducible and regulatory compliant medical products.
Quality Assurance
Make quality your Differentiator.
The following are scenarios within the Quality Assurance process with traditional manual steps. LuminLogic software is ideal for digitally managing every step of the way.
LuminLogic is the platform for:
Quality Management System (QMS) creation and maintenance
- Complying with your established regulatory framework for FDA or Global Quality System Regulations (e.g 21 CFR Part 820, ISO 13485)
- Creating, maintaining and distributing Policies/Procedures/Forms
- Applying personnel training requirements and monitoring training progress
- Monitoring and tracking the recurring review of Standard Operating Procedures (SOPs)
- Implementing an automated change control process
- Viewing and printing integrated master lists and logs
LuminLogic is the platform for:
Management Reviews and Trend Analysis
- Collecting trend data and sharing Management Review Inputs and Outputs
- Performing Management reviews, tracking attendance and documenting meeting decisions
- Demonstrating completion of annual Quality Objectives including review of SOPs and meeting actions
LuminLogic is the platform for:
KPI Creation and monitoring
- Communicating corporate Quality objectives
- Monitoring, tracking and viewing Key Performance Indicators (KPI) progress and graphs
LuminLogic is the platform for:
Supplier Management program
- Communicating the Approved Suppliers to Purchasing or applicable departments
- Qualifying suppliers and maintaining evidence of conformance to corporate acceptance criteria
- Monitoring Supplier performance and tracking certification expirations and renewals
LuminLogic is the platform for:
Training Program
- Defining training requirements and responsibilities via matrices
- Managing curriculum, eligibility, attendance, progress
- Monitoring training effectiveness and recurrence intervals
LuminLogic is the platform for:
Internal and External Audit management
- Creating and communicating audit schedules, plans and progress
- Tracking information and documentation shared with auditors
- Managing reviews, approvals of Audit results and reports
- Streamlining audits and access to audit requested information
- Making FDA audits easier and efficient
- Transitioning audit Q&A responses and checklists to audit reports
LuminLogic is the platform for:
CAPA management
- Issuing CAPAs
- Assigning CAPAs and notifying relevant parties of their pending actions
- Tracking CAPA status
- Creating, reviewing and approving corrective and preventative actions
- Managing supporting evidence of nonconformances and implemented actions
LuminLogic is the platform for:
Complaint Management
- Issuing Complaints and tracing to unique products and services
- Managing Investigation processes and escalating complaints to relevant parties
- Defining and tracking actions
- Tracing Complaints to CAPA records
- Viewing reports and dashboards of complaint process progress
LuminLogic is the platform for:
Deviation management
- Managing deviations
- Communicating and notifying relevant parties
- Maintaining deviations history
LuminLogic is the platform for:
Nonconforming product Control
- Document nonconformities
- Document investigation results and decisions
- Communicating and notifying relevant parties
LuminLogic is the platform for:
Design controls
- Managing all FDA design control phases
- Maintaining Design and Development plans and communicating responsibilities to relevant parties
- Trace design Inputs, design outputs and V&V actions
- Creating Bill of Materials (BOM)
- Performing design Reviews and track design decisions
- Implementing design change control and configuration management
LuminLogic is the platform for:
Device Master Record (DMR)
- Implementing a Device Master Record
- Maintaining DMR documentation and communicating with internal or external manufacturers
- Viewing integrated DMR indexes /span>
LuminLogic is the platform for:
Product Inspections & Acceptance
- Accessing released specifications
- Maintaining and communicating inspection control plans and data sheets
- Approve and document Final product acceptance
- Monitor and track NCRs and deviations
LuminLogic is the platform for:
Product Traceability
- Establishing Traceability practices for product distribution
- Maintaining product distribution traceability