Workflow + FDA Compliance & the use of Digital Signatures with single sign-on

['Mark Pyc']

> G'day WFers,
>
> Can anyone confirm the FDA stance on the use of Workflow as an approval
> mechanism? Does approval of GxP data have to be accompanied by a digital
> signature or does the Workflow logging mechanism and the SAP security
> solution constitute a sufficient auditable record?
>
> The background to this is the design of a general Master Data
maintenance
> solution potentially through WF. This would cover requests for changes
to
> most Master Data in the system and data creation requests in certain
> areas.
>
> A potential solution is the use of DMS Info records and their associated
> status management as a means of tracking a request from creation to
> approval and implementation and potentially validation. Questions come
> around how the initial requirements are physically gather and stored
(XML
> form, Word template, ??) and then how approval and tracking of the
request
> occurs.
>
> Anyone who can offer insight I would be grateful to hear of your
> experiences. I've been at one other pharmaceutical customer site but
they
> chose to continue with their current centralized paper based solution.
>
> Even further off the topic of WF specifics, can anyone confirm how
Digital
> Signatures work (or not) with single sign-on through the Portal? My
> understanding of Digital Signatures is that the user re-enters their
> sign-on password to confirm it is still them on the system. Does this
work
> for pure Portal users who don't have  a password stored against their
user
> master???
>
> Have fun!
> Mark