Life Sciences Validation and Critical Monitoring

j5_300.pngEMCOR Services Automated Controls offers cold-storage validation testing and critical monitoring services for the complex equipment used to store pharmaceuticals, lab samples, vaccines, product materials, and more. We help ensure that your systems comply with precise temperature and control specifications—and monitor and maintain these systems for continued reliability.

IQ, OQ, and PQ Testing

Our validation process includes installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) testing.

  • During IQ, we verify that your unit is properly installed and housed in environmental conditions according to manufacturer specifications.
  • During OQ, we check and calibrate your equipment’s essential operating controls and monitoring features.
  • Finally, during PQ, we test unit performance in a range of applications, collecting data on your unit’s cooling, energy usage, and temperature recovery abilities.

21 CFR Part 11 Compliance

j8_300.pngOur team can also evaluate your use and documentation of electronic records and electronic signatures according to all applicable regulatory requirements – including the FDA’s 21 Code of Federal Regulations (CFR) Part 11. After evaluation, we provide detailed results and make recommendations to help optimize your documentation method based on your specific operational needs.

As an authorized dealer for Automated Logic, we employ WebCTRL to help maintain precise conditions while capturing operating and procedural data. This building automation system can address every aspect of critical variance tracking, reporting, and data security necessary for FDA-regulated facilities.

NIST Calibration

We also offer single- and multiple-point thermometer calibration according to National Institute of Standards and Technology (NIST)-maintained standards of accuracy. Our experts in temperature mapping can verify that your units’ sensors are accurate and NIST-traceable—at a range of variables tailored to your facility’s specific climate needs.

Critical Monitoring and Alarming

Our trained technicians provide continuous, NIST-traceable temperature data logging to help you maintain your operation’s critical storage conditions. And with 24/7 monitoring and rapid response via our call center, our team is ready for repairs at a moment’s notice.

Our Complete Validation and Qualification Offerings Include:

  • IQ/OQ/PQ validation services for critical storage
    • Coolers
    • Freezers
    • Cryogenics
    • Warehousing
  • 21 CFR Part 11 compliance system
    • WebCTRL for life science facilities
    • Mean kinetic temperature data aggregation
  • NIST calibration services
    • Single point
    • Multiple point
  • Critical monitoring and alarming
    • 24/7/365 data monitoring
    • Call center response
    • Data trending