LMR Industrial Compliance offers a diverse portfolio of services across the regulated industries in the following areas:

• Regulatory Compliance
• Quality Plan & Quality Systems
• Quality Assurance & Quality Control
• FAT/SAT/Commissioning & Verification
• Qualification & Computer System Validation
• Process & Packaging Validation
• Cleaning Validation
• Food & Beverage Code & Safety
• Supplier Vendor Certification
• cGMP Audits and FDA Readiness Inspection
• GAP Analysis (as-is) & Remediation (to-be).

We can help.

Whether you need specific expertise and or are staff-limited, LMR Industrial Compliance can offer the professionals you need. Contact us, we are confident that we can support you to demonstrate compliance with innovative solutions.

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Quality &
Regulatory

• Quality Policies and Systems SOP’s

• Quality Risk Management

• Documents Control, Review & Approval

• Supplier Certification & Inspection

• Event Investigation and CAPA System

• Customer Complaints Management

• Annual & Periodic Product/ Data Reviews

• Maintenance & Calibration Program

• Food Hazard & Risks inspections & SOP’s

• FDA enforcement action Remediation Plans

• Training Program, curriculum and seminar

Qualification &
Validation

• Commissioning and Validation Project Management

• Development of execution strategies & SOP’s

• Master Plan, Validation Plan, Qualification Plan

• Commissioning, Qualifications (FAT, SAT, IOQ, PQ) & Validation:

  • Utilities, Facilities & Equipment

  • Laboratory Instrumentation

  • Method Validation

  • Cleaning Validation

  • Process Validation/ Product Transfer

  • Packaging Validation

Computer System
Validation (CSV)

CSV Master Plan & Validation Plan
• User Requirements & SPEC
• Traceability Matrix
• Commissioning & Qualification
PLC, SCADA, DeltaV, HMI, LIMS,
EMPOWER…
• Protocols & Plans Summary Reports
• 21 CFR Part 11 “Electronic Records & Electronic Signatures”
• CSV Vendor Audit Plan
• Serialization
• Data Integrity
• Laboratory Software