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Medical Validation in Propel

1.  IQ - We provide a completed IQ.   It is a single document that shows the completed installation information. 

2.  OQ - The OQ is feature based.  We provide a completed OQ.  This includes a protocol, executed protocol and evidence file for every Propel module with the exception of Supplier Portal 

3.  PQ is by definition a mirror of your configuration / SOP.  We do not provide a PQ with the exception of System Administration.  We include test cases in System Administration that address regulatory requirements such as 21 CFR Part 11 and other GxP requirements.  For example, we cannot make a statement that you are compliant with Password policy.  As a customer, you must ensure that your configuration in Salesforce is compliant with your internal SOP's and Salesforce configuration. 

4.  URS  The URS is a high-level statement of requirements.  We provide the URS but it is a "Framework" document that should be owned by the customer.  Every customer will configure their workflows different, either from a flow perspective, naming convention perspective, required fields etc.   Every customer will have different workflows.  Changes may include an ECO, ECR, DEVIATION or other flow.  The production Quality modules may include NCR, Complaints, etc....   My experience is that you will need a protocol for every workflow to show that the configuration behaves in the manner as defined in your SOP.  The depth of the protocol is up to you.   My experience is that you keep this simple and address "normal" user behavior.  You do not need to test every nook and cranny as that was done in the OQ.  Customers are expected to update the URS as they develop the PQ protocols. 

5.  FRS - The FRS is a very detailed feature based requirements documents.  Every feature listed in the FRS is addressed in the OQ. Propel PLM is a highly configurable solution.  We ensure that the options you select behave as expected.  We address master data such as Items, Accounts, AML, BOMS, Reports, Import/Export.  We address Workflow Changes and Quality, and finally, we address Propel related System Administration features.  An example of System Administration is ensuring that a Pick List can be changed and displayed correctly.  This is important because if you choose to change a pick list down the road, you can refer to the FRS tests in System Administration and not validate the change because it has been tested and is low risk. 

 6.  Trace Matrix - We provide a Trace Matrix.

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