User Requirement Specification (URS) for off the shelf software


Can anyone tell me what’s important to remember when preparing a “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.

GxP.pdf (850.1 KB)

Where is the software used? I think the answers will differ if IN a medical device, in a commercial device, used in development of a device / product, used in production of a device / product, etc.

Stay warm! From a rather temperate Texas! :slight_smile:

It will be used in the Medical Device industry as a statisical analysis tool on 6 of our production lines.

Tks yodon

Then the only thing I could add to peterok’s response would be for you to consider Part 11 (if to be cleared by the FDA).

In your expert opinions what would be required to validate commercially available software used to analyze data in medical device product development applications? I am specifically referring to software such as JMP or Minitab.

I don’ t know all the requirements, but I believe medical devices also have to comply with the CE Mark!