LMR Industrial Compliance
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Services

Reduce the Risk of non-compliance

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

• Regulatory & Compliance
• Quality Plan & Quality Systems
• Quality Control/ Assurance
• FAT/SAT/Commissioning & Verification
• Qualification & Computer System Validation
• Process & Packaging Validation
• Cleaning Validation
• Food & Beverage Safety Code
• 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.

Contact US ▸

 

Sustainable practices are Compliance

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Quality &
Regulatory

Development/ Revision/ Implementation of Quality Systems as:

  • Quality Management System

  • Quality Risk Management (QRM)

  • Documentation Management (translation, storage, retention)

  • Maintenance & Calibration Program

  • Food Safety (HACCP & HARPC)

  • Customer Complaints Management

  • Annual Product Reviews (APR)/ Quality Plans Reports

  • FDA enforcement action Remediation Plans

  • Review and approval of regulated documentation (batch, log…)

  • Training Program, curriculum and seminar

  • Supplier Certification Program & Audits

  • Event Investigation Program and CAPA System

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Equipment qualification & Validation Planning

Provide Commissioning and Validation Project Management as:

  • Development of Validation Program & execution strategies

  • Master Plan, Validation Plan, CSV Plan, Qualification Plan

  • Factory & Site Acceptance Test (FAT, SAT)

  • Validation Activities (protocol, execution & summary):

    • Utilities, Facilities & Equipment Qualifications

    • Process Validation/ Product Transfer

    • Laboratory Instrumentation

    • Method Validation

    • Packaging Validation

    • Cleaning Validation

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Automated
Systems

Computer System Validation (CSV):

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