BVJ Company, Inc.
Consulting on the PDM FDA Enhancement Project

SmarTeam

St. Jude Medical

FDA

Project Objective

SmarTeam approached BVJ with the following problem:

Their customer, St. Jude Medical, purchased a SmarTeam PDM System, with the intent of adding enhancements to the system so that the resulting system would conform to their understanding of the FDA regulation publication 21CFR11 (Part 11).

The scope of the development is to enhance the PDM functionality based on the FDA regulations. The main areas that require enhancements are:

1. Audit Trail - one central place to trail all modifications to the database (Add, Update, Delete and change in state. Login information - success and failure.).
2. Synchronized time stamp between client and server, email administrator if they exceed a tolerance threshold.
3. User verifications -
   • double login verification - same OS user name as PDM user name unless user is an administrator which requires a second login,
   • login verification upon life cycle change,
   • password expiration - by date or counter
   • force the user to change password after expiration and
   • only allow administrators to view the Audit Trail via a Visual Basic Application,
   • email administrator upon login failure.
4. Object Level Security - user can access objects in class that having one or more attributes set to particular values.
5. Database Structure - create a template that includes the Audit Trail tables and Implementation Document Class.

The administrator will be able to see the Audit Trail information in a tool similar to the NT Event Viewer. The tool should include the sequenced Audit Trail records, based on the recording time stamp. The administrator should be able to sort by date, user or object class.

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