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Hallo All
It is always nice to visit the Cove community.
I am a consultant in the field of ERP systems. Lately our company implemented an ERP system by a medical device manufacturer. The system manages orders (purchase and sales), inventory, BOM, production orders including the work plans and operations and resources, traceability, customer details for delivery and etc. Last week the customer requested to know he may validate the system.
I know that validating means:
1. Identification of the parameters/characters that will affect the Medical device, on which the ERP system has effect
2. Identification of the processes in the ERP system that may affect the parameters of the medical device
3. Creation of criteria (the requirements) - Values which the parameter should achieve
4. To define the tests that will examine these criteria
5. To prove that the criteria is being fulfilled
6. Application of configuration control
Very important - Each process is automatically verified by the system, before the system saves the data on the data bank. For example, when a production order is input, the system verifies that the right data was input and verifies the links between the different system elements (Produkt, Version, BOM, Set of Operations, Set of required resources and etc. - until the level of the label) using procedures and functions.
My questions are:
In this case does is it really required validating the system parameters or may I settle for the verification? When I need to verify the system parameters, which parameters should I to verify?
Thanks in Advance
Itay
It is always nice to visit the Cove community.
I am a consultant in the field of ERP systems. Lately our company implemented an ERP system by a medical device manufacturer. The system manages orders (purchase and sales), inventory, BOM, production orders including the work plans and operations and resources, traceability, customer details for delivery and etc. Last week the customer requested to know he may validate the system.
I know that validating means:
1. Identification of the parameters/characters that will affect the Medical device, on which the ERP system has effect
2. Identification of the processes in the ERP system that may affect the parameters of the medical device
3. Creation of criteria (the requirements) - Values which the parameter should achieve
4. To define the tests that will examine these criteria
5. To prove that the criteria is being fulfilled
6. Application of configuration control
Very important - Each process is automatically verified by the system, before the system saves the data on the data bank. For example, when a production order is input, the system verifies that the right data was input and verifies the links between the different system elements (Produkt, Version, BOM, Set of Operations, Set of required resources and etc. - until the level of the label) using procedures and functions.
My questions are:
In this case does is it really required validating the system parameters or may I settle for the verification? When I need to verify the system parameters, which parameters should I to verify?
Thanks in Advance
Itay