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.