Quality Systems Consulting

Quality Systems Consulting

Quality Systems Consulting

LexaMed can design a robust quality system encompassing all of the necessary elements to ensure compliance with the client’s desired registrations/certifications.  LexaMed has proven expertise in the following quality areas:

Quality System Development

 

  • Effective controls and monitoring tools
  • Integrated Systems
  • CAPA Systems
  • Deviation and Product Complaint Management Systems
  • Design Control
  • Management Review
  • Supplier Approval Program and Audits
  • Out-of-Specification Investigations
  • SOPs and Test Method Generation
  • Stability Program
  • IQ / OQ / PQ Validations
  • Specification Generation
  • Equipment Validation and Qualification
  • Process Controls
  • Equipment Cleaning Validation
  • Critical Utilities System Qualification
  • Validation of Compressed Air and Gases
  • Change Control Management
  • Compliant System
  • Risk-based Validation Plan
  • Data Trending
  • Employee Training Programs

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.