COMPUTER SYSTEM VALIDATION (CSV)

According to the GDP, computer systems must be validated. This also applies to temperature monitoring computer systems.

Dyzle delivers computer system validation (CSV) as an integral part of the solution. Therefore, Dyzle’s solutions perfectly match a GDP-compliant environment. In order to achieve this, Dyzle has implemented 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 IQ and OQ have been drawn up;
  • Protocols have been implemented to a system that match a client area in the pharmaceutical industry;
  • Tests have been successful.

A complete GDP- compliant and cost-effective validation of all GDP-requirements is an integral part of our solution. Therefore, there is no need to train your own personnel in validating our solution. Neither will you risk losing knowledge. Dyzle is fully trained and competent, dividing investments and running expenses over multiple clients. This results in cost reductions, thus saving you money.