TABLE OF CONTENTS Although not often considered in the validation of a CDS, the purchase order is the start of the system configuration. A plan is also required for where to install the hardware (server, data acquisition servers and the chromatographs to be connected to the system) and the contract protects the rights of both the vendor and the customer.
Clause 18 states27:
When outside agencies are used to provide a computer service, there should be a formal agreement including a clear statement of the responsibilities of that outside agency (see EU GMP Chapter 7).
There is little in the regulations about the contract. However, it is for business reasons that a contract is important, especially with a new system and/or a new vendor.
If the vendor audit, the quote and the CDS software are acceptable, you will be raising a capital expenditure request (or whatever it is called in your organisation) and then generate a purchase order. The quote and the purchase order are a vital link in the validation chain as they provide a connection into the next phase of the validation life cycle: the qualification phase. Before the order is placed, there is a small matter of the contract.
If you never consider a contract just pause to consider the following questions:
Which organisation writes the contract for the CDS application you...
