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Every year we perform mapping on hundreds of Controlled Temperature Units across Europe. The easiest option for us would be to use a simple template to perform the mapping. Which is why our customers are often surprised when we tell them we don’t use templates. All of our protocols are bespoke to each of our clients.
We write individual bespoke protocols to ensure the testing, validation equipment and acceptance criteria are suitable for the unit under validation. It is important to ensure the protocol is designed for process and we do this by:
· Risk Assessment of the process
· Selecting the most appropriate testing for the equipment use
· Ensure the testing conforms to client SOPs
· Selecting the most suitable validation equipment
A well written protocol will clearly show critical parameters, acceptance criteria and results. It will be specific for the unit under test and is suitable for the process. By selecting the best equipment, execution timelines can be reduced while increasing the clarity in raw data and results.
If you would like to see copies of our protocols, we have executed versions available for review. We have performed IQOQ and PQ validation on our Controlled Temperature Units, in our Training and Development laboratory. One of our engineers would be happy to visit your site and go through out documentation. Please contact Chris Maughan via email for more information.