WHY USE
STRATEGNOS FOR YOUR
TEMPERATURE MONITORING
NEEDS?

Strategnos provides end-to-end monitoring report solutions making the management of monitoring data that much easier so you can focus on your customer.

We provide audit-ready temperature monitoring reports, with detailed analysis of the data, and OOS (Out of Specification) results above or below the acceptance criteria with our proprietary methods and software, tailored to your equipment.

 

Common challenges faced by industry requirements:

  • Management of collected data
  • Data must be accessible
  • Data must be traceable
  • Supported by calibration certificates
  • Data should be reviewed and analysed for any corrective action

 

 

We can supply reporting by shipment, weekly, monthly, quarterly or yearly
tailored to your requirements.

 

  • Data can be categorised and linked to relevant calibration certificates.
  • Analysis by route, branch and season.
  • Audit-ready reports with suggested corrective action where appropriate.

REGULATORY OVERVIEW

SAHPRA

South African Health Products Regulatory Authority
Good Wholesale Practice for Wholesalers – 2016

SAPC

South African Pharmacy Council
Good Pharmacy Practice – 2017

 

Num-05

14.5.7. Good storage practices and loading configurations should not lead to the obstruction of air distribution; e) Have sensors for continuous temperature monitoring and alarms located at the points representing the temperature extremes.

2.3.5.5. (h) Temperature data loggers, refrigeration tags, freezer tags, log tags or cold chain monitoring cards that complies with or meets WHO specifications must monitor the temperature of the loaded area of the transportation throughout the trip, and the validated cooler box packaging must have at least a temperature monitoring device that complies or meets with WHO specifications.

COMPLIANCE IS A JOURNEY.

Let us be your partner to ensure cost effective, consistent adherence to compliance requirements.