LexaMed’s concept of quality systems involves the synchronization of procedures and processes thus yielding a quality product. This approach allows us to ensure your compliance with cGMP or ISO requirements. LexaMed can build a robust quality system encompassing all of the necessary elements to ensure it is in a state of constant control.  LexaMed has proven expertise in the following quality areas:

Quality System

  • Effective controls and monitoring tools
  • Integrated Systems
  • CAPA Systems
  • Deviation and Product Complaint Management Systems
  • Design Control
  • Management Review
  • Supplier Approval Program and Audits

Laboratory Control System

  • Laboratory Investigations
  • SOPs and Test Method Generation
  • CAPA Plans
  • Stability Program
  • IQ / OQ / PQ
  • Specification Generation

Production System

  • Equipment Validation and Qualification
  • Process Controls
  • Cleaning Validation

Packaging & Labeling System

  • Specification Generation
  • Label Control System
  • Contamination Prevention
  • Product Inspection Process

Facilities & Equipment System

  • Critical Utilities System Qualification
  • Validation of Compressed Air and Gases
  • Clean Room Qualification
  • Sterilization Processes

Materials System

  • Incoming Inspection Program
  • Supplier Qualification
  • Supplier Audits
  • Warehousing Procedures

Documentation Systems

  • Design Control – Input/Output
  • Risk Management – ISO 14971
  • Complaint – Medical Device Reporting – Vigilance Systems
  • Device Master Records – Device History Records
  • EU clinical literature research and evaluation

Services

  • Author SOPs and Test Methods
  • Change Control Management
  • Compliant System
  • Risk-based Validation Plan
  • Data Trending
  • Testing Execution
  • Technical Transfer Assistance
  • Employee Training
  • Project Management
  • Benefits

    • Improved Efficiency
    • Tailored to Customer Needs
    • Drive Down Costs
    • Adherence to FDA and Other Regulatory Agency Compliance
    • Allows Redeployment of Internal Resources
    • Quality Compliance

    Quality Compliance

    LexaMed provides Quality Management System services compliant with:

    • 21 CFR Part 820-Quality System Regulation
    • 21 CFR Part 210/211-GMP in Manufacturing, Processing, Packaging, or Holding of Drugs:
    • General/GMP for Finished Pharmaceuticals
    • 21 CFR Part 111-GMP in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
    • 21 CFR Part 11
    • EU GMP, Chapters 1-9, Annex 1
    • ICH Q7A-GMP for APIs
    • ICH Q8-Pharmaceutical Development
    • ICH Q9-Quality Risk Management
    • ICH Q10-Pharmaceutical Quality System
    • ISO 13485
    Anne Schuler

    Anne Schuler

    Subject Matter Expert

    Anne Schuler is our resident subject matter expert in Quality Management. Feel free to contact Anne with any questions via email at aschuler@lexamed.net.

    Contact Anne

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