ERP Software Validation - required or not?

I

itay26

#1
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
 
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yodon

Staff member
Super Moderator
#2
A little clarification on your items 1 & 2: not just how it (may) affect the device (which an ERP system in and of itself wouldn't) but also how it may affect information related to the device (e.g., the quality records).

Your item 3 is really the key to the rest. The user's requirements for how the system is used in HIS (or HER) environment is what testing should target. If they are relying on the system range-checking, that should still be verified.

Presumably the system has local configuration (access levels, etc.). Those should also be verified (as working per the requirements).

One other thing that I would consider for validation (especially for an enterprise-level app) would include simultaneous access

ERP validation is typically not a trivial exercise and I really just scratched the surface. The validation should be in line, of course, with the client's Validation Master Plan and, again, should be tailored for how the system is used by the client (not a verification of general system capabilities).
 
K

Kane Nawrocki

#4
ERP Software validation must require because when particular user wants data from ERP software then there is need to login of user.If login is not available then anyone can steal and see your data easily.So prevent this kind of situation every ERP software must need validation.through which we can validate product name, product data and many details about product.Now a days some advanced ERP software arrived in market.that are Cloud ERP software or Cloud Accounting Software.By using this type of software we can easily share business resources or data or information on cloud.so its easy to reach each and every person to notify if normal changes done in production or sales chain or some other thing.So i personally prefer Cloud ERP software which are not very costly.
 
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