Closed project or turn-key models. The client contracts FIVE to prepare one or more previously specified documents. FIVE acts in the validation and qualification life cycle, preparing to provide all the documents foreseen in the GAMP5® (Good Automated Manufacturing Practice guideline), including the application of tests in all phases. There is also the possibility of preparing specific documents, such as but not limited to Master Plans for System Validation or Equipment Qualification, Validation or Qualification Plans or Protocols, Risk Assessment, Inventory, and Procedures, among others.

Other products
FIVE Training
FIVE Audit
FIVE Manager
FIVE Consulting
FIVE Evaluation

GAMP5® is a guide that has its intellectual rights reserved by ISPE™. Available for purchase at