is sharepoint compliant with iso 13485

[RichyRich]

Hi
We are looking to have an ISO 13485 Audit, and am wondering if the document
control system in Sharepoint 3.0 is acceptable to the ISO standard

thanks

Richard

[kayka...@gmail.com]

Hi Richard

As far as I am aware SharePoint is compliant with requirements within ISO 13485,however Sharepoint needs to be configured correctly in order to be Compliant.

1) SharePoint document Versioning, needs to be activated, A "label" feature can be used within sharepoint to ensure version numbers in word documents and sharepoint match, this can also be done for document status.
2) Ensure that when changes take place revision history records are updated, (Add a comment when changes when checking in the document)
3) Ensure permissions are assigned appropriately so that not everyone can edit documents
4)Use Approval workflows for the approval of documents, a review workflow can be used too.
5) add columns for (Author, Reviewers, Approvers etc)
6)Ensure that SharePoint is Validated, A COTS IUV (Commercial off the shelf - Intended Use Validation) can be used for this, this will only be a basic document stating that you are only using the software as intended and not modifying any parameters of the software. (ie: custom Coding)
7) One Gray area is electronic signatures, however Microsoft has released a document stating how this can be achieved, look-up "Sharepoint FDA 21 CFR Part 11", this modification would require a full IUV however only testing the custom Coding for electronic signatures only.

Anyways hope this helped!