Auditing

Auditing

Medical Device and Pharmaceutical Manufacturing Operational Audits

LexaMed is an internationally recognized industry leader at performing Medical Device and Pharmaceutical Manufacturing Operational audits. Our experienced team of auditors and subject matter experts are eager to work with your company to provide a comprehensive assessment of all aspects of your facilities, quality systems and suppliers. Your company will benefit from the safety and confidence gained by our comprehensive, “eye of the agency” evaluations. Contact LexaMed to discuss our specialized auditing capabilities which include, but are not limited to:

 

Pharmaceutical:
  • Pharmaceutical cGMP: 21 CFR Parts 210/211
  • IPEC-PQC Excipient cGMP
  • API cGMP: ICH Q7A
  • Non-Sterile Solid Dosage
  • Large and Small Volume Parenteral
  • Isolator Technology
  • Terminal Sterilization
  • Aseptic Operations
Medical Device:
  • Medical Device CFR: 21 CFR Part 820
  • Quality Systems ISO 9001 and 13485
  • Canada MDR (Medical Device Regulations)
Sterilization:
  • All sterilization Modalities
  • Parametric Release
Laboratory:
  • Laboratory GLP: 21 CFR 58, ISO 17025
Validation:
  • Equipment, Process, and Method Validation

Compliance Auditing

LexaMed offers a full spectrum of focused Domestic and International Compliance Audits which include, but are not limited to:

  • System GAP Analysis for compliance with US and International statutory requirements, ISO standards and industry guidelines
  • Pre-PAI Preparedness
  • Pre-FDA GMP Preparedness
  • Pre-ISO Certification
  • Vendor / Supplier Qualification / Re-Qualification
  • Internal Corporate Compliance

Verification

LexaMed has state of the art, integrated Laboratory, Research and Consulting capabilities and is uniquely qualified to assist with post-audit verification activities which include, but are not limited to:

  • Generation and Management of Compliance Action Plans
  • Assistance with Execution of Remediation Activities
  • 483 and Warning Letter Responses
  • Post-Audit Sustainable Compliance Evaluations

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.

Leave a Comment