1Z0-931 Autonomous Database

CSV Fall 2020 Final Exam File upload question

INSTRUCTIONS:  Download this file and include your name in the file name before you upload it into Canvas.  Complete the table exactly as described in the scenario.  Credit will only be given for each complete and appropriate entry.  Points will be deducted for inappropriate/incorrect/missing entries.

Scenario

You are the validation lead for a young company that does not have many polices and procedures in place.  They are implementing systems for regulatory compliance and you are ensuring their newly purchased Complaint Management system is installed and validated.  The system will be installed on new computers in the existing hosting data center used by the company.  The system is highly configurable.

Complete the validation deliverables matrix for the system using the table below.  Enter the validation deliverable for the listed system in the first column (include name of document and a brief description of it’s purpose).  The use of abbreviations is discouraged.  All validation deliverables must be clear and unambiguous or no credit will be given.  List the deliverables in the approximate order of their creation/approval in accordance with the validation lifecycle. 

Assign roles where it has <role> then populate each cell with the role’s responsibility for the deliverable using the codes below. Add/remove rows as needed. 

 The following codes are to be used in the table:

(C) – Create:  Author of a document/creates a document

(A) – Approve: Signs for approval

(R) – Review:  Formal review requiring signature

(E) – Execution:  Applies to protocols/test cases, role(s) responsible for testing 

Add an asterisk if there is a plan to combine any deliverables or incorporate some deliverables in another deliverable, or any other project specific approaches, and note the reason below the table.  Leave no blanks – use “—“ to indicate a strike through or enter NA.

Deliverable Name

Deliverable Responsibilities

Validation Deliverable

<role>

<role>

<role>

<role>

<role>

* [Use this space to indicate any combined deliverables with an explanation for each]

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