Change is a constant in the world of clinical study planning. In The Art of Making Changes Part 1: Five Keys we talked about the stress change can generate, and about the five essential elements for achieving painless change management for IRT (IWR/IVR) systems. The present article outlines the components of a successful management process for technical change.
- Use an issue tracking system for all requested changes. This enables you to assign and re-assign the issue to different staff as clarifications occur and questions arise between the initial change request and resolution, and to designate closure when all is done.
- IRT Project Manager (PM) initiates the case and bears primary responsibility for ensuring that all stakeholders have the same interpretation of the request being made. This is a key
- PM obtains from system developers/configuration managers the hours required for the change, by various personnel, and any concerns/issues.
- Proposals/Contracts personnel provide a quote for the change to the client.
- When all questions are resolved, a Change Order with full descriptive text and associated time and cost is prepared for client’s written authorization. Here again it is key that the document accurately describe the change(s) required.
- Client signs and returns the Change Order.
- System developers/configuration managers implement change in accordance with company SOPs.
- Changes undergo appropriate testing and quality review, as required by company SOPs. All issues and questions are resolved.
- Changes are released for User Acceptance Testing (UAT), as appropriate.
- Issues and questions raised during UAT are resolved, retested, finalized.
- Client provides written authorization for the new version of the system to be moved into the production environment and the system made available to end-users.
- Issue tracking system is updated to indicate the change is finalized and in production. system. Issue is closed in issue tracking system.
- Finance personnel are notified for invoicing.
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