Quality Management

Quality Management

Medical Device and Pharmaceutical Manufacturing Operational Audits

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
Facilities & Equipment System:
  • Critical Utilities System Qualification
  • Validation of Compressed Air and Gases
  • Clean Room Qualification
  • Sterilization Processes

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

If you would like to discuss your project with one of our experts, please fill out our contact form, and we will be with you immediately.

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