IT Quality Management System for a Healthcare company.

  Overview

All industries strive to create quality products and services and have instituted policies and procedures to insure that these goals can be achieved consistently. Nowhere is this essential than with healthcare related companies who also operate under several regulations. These enterprises require strict internal project management to ensure that their system are completely validated and have achieved the highest degree of confidence in their correct functionality. In addition to providing our own, validated and transparent project development methodology, Discoverture Solutions’ consultants have helped our clients achieve this same confidence.

  Opportunity Summary

A sizeable company involved in the Healthcare field was required to track all project documentation and validation status for all internally and externally sourced IT projects. However, their existing manually intensive tracking methods and limited staff were becoming stressed from an ever-growing list of projects and their numerous project artifacts. Any potential project lapses made them vulnerable to FDA audits. In addition, their ongoing process improvements resulted in an evolving methodology that was difficult to communicate to the extended, global development team.

  Solution

The Quality Assurance team engaged us to resolve these issues. As a result, a Quality Management System was developed to support Validation team members, Project managers, Auditors and Administrators. This system embodies their developing methodology and Standard Operating Procedures. The New Project Wizard allows Project Managers and Validation Team members to cooperatively classify a new project and apply correct project approach with its incumbent documentation requirements. The Wizard creates the base version of the required document and delivers them to the responsible project members. In this way, not only does each project get off to the correct start, but also the Quality System is prepared to track the delivery and validation of each project artifact.

The system is able to track projects as they are structured in the real world, with multiple project versions and complex dependencies. Projects can be grouped and organized by the business unit or auditing requirements. In addition, the system tracks all related project resources such as team members, change requests, and suppliers.

  Benefits

As a result, this company can now be assured that they are in full compliance with all FDA standards for validated system development, without increasing their staff. Also, since the Quality System now manages process improvements insuring that the latest revisions are delivered with each new project, compliance has been greatly increased.

Now that the Quality Management System is knowledgeable of all projects and their documentation requirements, it is able to automatically notify the appropriate staff of required validation actions and schedules via browser and e-mail reminders.