Kbase P25201: Is Progress compliant with 21CFR Part 11?
| Autor |
Progress Software Corporation - Progress |
| Acesso |
Público |
| Publicação |
09/11/2004 |
|
Status: Unverified
GOAL:
Is Progress compliant with 21CFR Part 11?
FIX:
As stated in the 21CFR Part 11 website FAQs (http://www.21cfrpart11.com/pages/faq/index.htm):
"At best, the vendor can offer an application containing the required technical requirements of a compliant system."
The application vendor in this case is not Progress Software but the ISV or end-user.
Title 21 CFR Part 11 is a systemic look at a deployed application.
It is up to the ISV to ensure that the application is compliant.
Therefore Progress does not 'certify' the technology itself (i.e. database features).
The application built by the ISV/End-User with Progress must be certified.
Progress OpenEdge provides many features that can be used to provide application compliance with 21 CFR Part 11 but it is up to the application designer as to the implementation.
Some of the OpenEdge features available for 21 CFR Part 11 compliance are as follows:
Security: Database logins, special password protected entry fill-ins etc.
Audit trails: Database Schema triggers, 4GL Business logic etc.
Electronic signatures: The Database RAW Data type, the ability for the 4GL to access 3rd party applications etc.