What is Validation?

Validation in the Pharmaceutical Industry can be described as “documenting that a process or system meets its pre-determined specifications and quality attributes”

Typically this can encompass

• Validation that a facility can maintain required storage and transportation temperatures by Temperature Mapping  
• Validation that the system used to monitor the temperature in the facility meets the requirements of the regulatory authorities

The IceSpy Wireless Temperature Monitoring & Alarming system is capable of being validated to the requirements of FDA 21 CFR Part 11.

How can Rototherm assist?

Our Quality & Validation Department can assist by:

• Working with you to complete the execution of the supplied Validation Document IQ/OQ (Installation & Operational Qualification).
• Using your URS (User Requirements Specification) we can produce  the following for your approval
  • FDS (Functional Design Specification)
  • VMP (Validation Master Plan)
  • Customise OQ testing to your specific requirements as required
  • Performance Qualification Testing
  • Using Change Control validate Software upgrades and/or Hardware additions/changes to validated systems.