User Requirement Specification (URS) for off the shelf software.

[janwe]

Hello
Can anyone tell me what's important to remember when preparation an " User Requirement Specification" for Off-The- Shelf software?

Tanks in advance from a could and snowy Norway

[Ajit Basrur]

Originally Posted by janwe

Hello
Can anyone tell me what's important to remember when preparation an " User Requirement Specification" for Off-The- Shelf software?

Tanks in advance from a could and snowy Norway

For Commercially Off The Shelf (COTS) software, the GAMP - Good Automated Manufacturing Practices document categorises in Category 3

Category 3 - this is "commercially available off the shelf software" (COTS) including OpenOffice, Microsoft Office, MATLAB and similar packages. The packages themselves require no validation and the suppliers require no Supplier Audit.

However, upgrades must be considered carefully and a risk based analysis programme in place to carefully examine any upgrade programme. Configuration is limited to the environment set-up and parameter values IQ verifies the name and version / revision. OQ tests the requirements.

I am also attaching a PIC/S Document - GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN REGULATED “GXP” ENVIRONMENTS, which contains useful information.

[qagirl]

Mr. Basrur,

I also have a GAMP question. In our customer's URS, they want us to make a statement that all of the materials that come into contact with our customer's medical device, are approved FDA Materials. But, as you probably know, the FDA does not publish an approved materials list. Does anyone know of any guidance documents from the FDA about FDA approved materials? I know that over time, because the FDA approves materials in medical devices, industry knows what these materials are, such as Stainless Steel and Delrin - but there are probably some other more obscure materials that are also approved. HOw to find out what these materials are, if there is no official list from the FDA?