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.
Gamp4
As an option Lytzen can offer a complete package of qualification and validation documentation based on GAMP4 (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.
FDA-approval
A lot of our customers have production facilities, needed to be approved 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 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.
