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 and humidity range  by Temperature and Humidity  Mapping
• Validation that the system used to monitor the temperature and humidity  in the facility meets the requirements of the regulatory authorities

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)
  • Perform IQ/OQ Qualification Testing
  • Validate Software upgrades and/or Hardware additions/changes to validated systems.