Quality Systems

  • Quality Systems at EKG Labs

    At EKG Labs, our commitment to quality and compliance is a driving force behind our operations. From sample receipt to report delivery, our Quality System is designed to provide our customers with the highest level of quality available, in a manner that often exceeds customer expectations.​

    EKG Labs has a comprehensive Quality System that ensures data produced by our laboratory meets applicable regulatory requirements, is scientifically sound and is rigorously documented. Key aspects of our system include:

  • EKG Quality Systems
​​EKG Labs Data Integrity
  • Comprehensive record of all direct and indirect laboratory components surrounding each project
  • A 100% review of this record for compliance with applicable internal procedures and regulations
  • Client-interactive, timely investigations for out-of-specification or suspect test results
  • Extensive IQ/OQ/PQ protocols for instrumentation used in regulated projects
​Quality Training
  • New hires undergo specific training regimens, tailored to their defined role, to ensure that they are competent to perform their job function prior to being released to task​
  • Active employees undergo rigorous ongoing training and assessment in areas such as Good Documentation Practices, instrument knowledge, SOP compliance and GXP regulations
  • Key project personnel stay current on compliance and technology by attending external seminars conducted by industry leaders
​Quality Oversight and Audits
  • FDA Registered (FEI Number 3010232943) and GDUFA Self-Identified. Our most recent audit was in June, 2016
  • DEA licensed to handle Schedule I – V controlled substances. Our most recent inspection was December, 2015
  • Continual monitoring of study protocols, SOPs and methods to ensure strict adherence and testing uniformity
  • Routine review of newly published FDA guidelines to maintain a system which evolves as regulatory guidelines are updated
  • Periodic, independent audits of all aspects of the Quality System
  • Prompt identification of divergence from written procedures with immediate assessment of their potential impact on study integrity

​We welcome all current and prospective customers to conduct audits and inspections of our cGMP facilities and systems. Schedule an audit.