When a certain temperature limit or storage time is exceeded, you run a great risk of loss and product write off. Continual insight into the conditions under which your products are produced, stored or transported reduces this risk. Dyzle helps you achieve this and therefore reduces your lost product write-off costs.
Always GDP compliant
To comply with (international) legislation, Dyzle continuously adapts systems and processes. In this respect,
GDP and Gamp guidelines and protocols are always the primary focus. All processes are structurally validated
and comply with today’s as well as tomorrow’s requirements. In this, Dyzle is unique!
Validation Of the DYZLE “computerized system”
Dyzle’s solutions fit seamlessly into a GDP compliant environment. To achieve this, Dyzle has taken the following steps:
- User Requirements have been defined
- Risk assessment has been carried out
- System impact has been determined
- 21 CFR part 11 functionality available
- Protocols and documents for the IQ and OQ have been drawn up
- Protocols have been carried out in a system comparable to a customer environment in the pharmaceutical industry
- Tests have been successfully completed.
Fully GDP compliant and cost-effective
Validation of all GDP requirements is an integral part of our cold chain solution. This means that you do not need to train your own personnel to validate our solution, nor do you run the risk of knowledge ‘running off’. Dyzle has all the necessary expertise and divides the investments and ongoing charges over multiple customers, which results in cost savings for you.