Laboratory Auditing Services

  • EKG Labs provides comprehensive laboratory auditing services to support product development for medical device and pharmaceutical products. As a contract laboratory, we understand what it takes to develop robust quality systems and how to make sure those quality systems are being followed. You can take advantage of our experience by choosing us to audit your analytical or manufacturing partner.
  • audit checklist
General Quality System Audit​

Whether you are getting ready to take the leap and register your facility with the FDA or simply have a FDA inspection anticipated in the near future, our experienced auditors can perform an external audit of your Quality System and provide you with valuable feedback on areas of improvement and potential system failures. Some general quality system audits include:

  • ​Regulatory Compliance Audits – Compliance of your system to 21 CFR Parts 58, 210, 211, and 820​​
  • Laboratory Audit​s – Assistance developing a master validation or metrology plan​
  • Training Program Audit​s – Design and implementation of an appropriate training program
Vendor and Supplier Audits

EKG Labs can free up valuable time and resources by assisting with your vendor and supplier audits. We can act as an extension of your Quality Assurance Unit and take the lead on auditing prospective material and component manufacturers. Additionally, if you are seeking to outsource a portion of your manufacturing and analytical work, we can leverage our knowledge of quality systems to help you find a reputable partner with a solid regulatory record.

​Protocol Audit

Proper protocol design is a crucial aspect of both scientific accuracy and quality compliance. Our Quality Assurance team can assist you with the design and audit of internal and external protocols. Examples of protocol-based laboratory auditing services include:  ​

  • IQ/OQ/PQ protocol set-up and execution​
  • Extractable and Leachable Studies
  • Stability Studies
  • Method Validation
  • Method Transfer
​​Data and Project Audit​​​​

Do you have compliance concerns with a project completed by another vendor or service provider? Do you need a team to review data for your submission? Our team can audit submission data for:

  • PMA – Premarket Approval​
  • 510(k) – Premarket Notification
  • IND – Investigational New Drug Application
  • NDA – New Drug Application
  • ANDA – Abbreviated New Drug Application (generic)
  • NADA – New Animal Drug Application