Apart from user manual which is delivered with each machine, Tien Tuan is able to provide qualification documents complying to the most up to dated regulations in pharmaceutical industry and following cGMP and GAMP Guidance. Customers can benefit from experience and expertise of our validation experts.
Validation documents are results of the cooperation between validation experts between Tien Tuan and our clients for the whole product life cycle.
Our complete validation documents include:
• Quality and Project plan
• Functional specification
• Design specification
• Installation qualification
• Operation qualification
• Traceability matrix
• Change control
