As the demands from the regulatory authorities regarding documentation have become increasingly extended, the requirement for first class qualification & validation documentation is a necessity.
Along with the comprehensive operation and maintenance manual, IQ/OQ qualification documents are standard when buying the Lytzen depyrogenation oven. Lytzen also offers QA-documentation.
As an option Lytzen can offer a complete package of qualification and validation documentation based on GAMP (Good Automated Manufacturing Practice).
An easy access to validation can save a lot of money and, not to forget, a lot of time. 1 week more for validation means 1 week less for production. Lytzen can of course offer assistance for completion of the GAMP documents.
A lot of our customers have production facilities demanding approval by FDA. Accordingly we put a special emphasis in making depyrogenation ovens that ensure that the customer will get a very smooth inspection by FDA. We are keeping ourselves continuously updated on the newest directives from FDA and no production facilities have ever been turned down by FDA because of our products.
“The validation went very quickly and everything went well. This was the fastest qualification I have ever performed on a depyrogention oven. Since the installation there have not been any issues with the oven”.
- Jeremy Griffin, Grand River USA.