Computer System Validation Principles and Practices Supplier Audit Plan - IT Computer Science Assignment Help

Assignment Task:

Task:

Your TGA regulated pharmaceutical company has appointed you to determine whether ‘SoftwareCo’ are a suitable company to supply a Document Management System (DMS) to manage all controlled documents (such as SOPs, WIs and Batch Documents). These documents are used to produce your product and to make quality decisions about your product, therefore the system must be validated. As part of the validation process, the vendor must be audited to establish their suitability as a supplier of such a system.

You sent out a user requirements document to a number of potential suppliers and it seems that SoftwareCo could provide a suitable solution.

You have sent SoftwareCo a vendor audit questionnaire as the next step in your process. The response from SoftwareCo is attached.

Your job is to review the questionnaire response from SoftwareCo and prepare an audit plan focusing on the areas you have assessed as needing more investigation before agreeing to source software from this supplier. You must justify your choice of areas to review using risk management principles. You are not required to produce a formal risk assessment document.

Documentation to Produce:

1. A report giving your overall assessment of the supplier’s questionnaire response, and your justification for your audit plan. The length is to be 500 words (Min: 450 words, Max: 700 words) excluding cover page, audit plan and references

2. An audit plan showing how you will evaluate areas of uncertainty or areas that require confirmation at an on-site audit. The length is to be 1-2 pages excluding cover page, audit report and references

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