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Medical Device Mapping & Validation (Cold Chain Packaging)

As Medical Device Inspectors become more familiar with the expectations of the Drug Inspectors for evidence of meeting labelled storage conditions, mapping and validation compliance is becoming an area of discussion during Medical Device inspections.

The Medical Device Regulations require that procedures are in place to address storage and handling requirements. If your product has specific storage requirements, then you need to be prepared to provide evidence that storage requirements are being met. We can develop programs and protocols for you which help provide evidence that your handling of products complies with storage requirements.

DSA offers a wide range of services with respect to mapping, qualification & validation:

Mapping and Validation Studies:

Coolers (IQ/OQ/PQ)
Freezers (IQ/OQ/PQ)
Incubators (IQ/OQ/PQ)
Shipping Containers
Transportation Vehicles
Storage Areas

Qualification or Verification Studies:

HVAC (IQ/OQ/PQ)
Packages
Carriers
Shipping Routes

Validation Studies:

Computers
Analytical Methods
Manufacturing Process
Cleaning

Please contact us to receive a quote on our mapping and qualification studies.

"We are very pleased with the results of our packaging qualification study. You’ve been a tremendous support in qualifying our patient bags. We would not hesitate to recommend your services to any of our Pharma clients."

Donald,
Sales Representative

"It has been great working with your team on this project. You’ve given us binders of evidence to show clients that we run a state-of-the-art warehouse. It’s a great feeling to know that we can welcome any client auditor into our building and not have to fear the “validation” question."

-Bill,
Warehouse Manager