Life Sciences Validation and Critical Monitoring

EMCOR 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 your systems comply with precise temperature and control specifications, and monitor and maintain them for continued reliability.

Our complete validation and qualification offerings include:

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

21 CFR Part 11 Compliance

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

As an authorized Automated Logic dealer, we use WebCTRL to help maintain precise conditions and capture 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 multi-point thermometer calibration in accordance with National Institute of Standards and Technology (NIST)-maintained accuracy standards. Our experts in temperature mapping can verify that your unit’s 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. With 24/7 monitoring and rapid response through our call center, our team is ready to respond to repairs at a moment’s notice.

Contact us today to learn more about our validation and critical monitoring services.