A compliance-focused change management solution should: consider the following solutions
- Many organizations have large number of SOPs that cross-relate to changes. Modern organization maintains a centralized queue to manage and confirm incoming change requests from all departments.
- The organization should have well defined SOP, written procedures for identification, ownership, justification for proposed changes. The documentation involved should clearly define, scope and justification of proposed changes; Record all impacted areas, assign tasks, and propose change plans.
- Change management system of the organization should be scalable and has capacity to handle complex changes when necessary.
- Enable one or multiple assessments to allow experts to evaluate the impacts of a change, accounting for results of impact assessments before routing for approval.
- Track and monitor changes in the organization as they are executed and verified.
- Effectiveness of change should be measured holistically at all levels.
- Integrate with other departments regarding new changes to be implemented and provide additional trainings and certifications.
- Incorporate electronic signatures during impact assessment, review, approval within the change process to ensure compliance with 21 CFR Part 11. (updated on 26.09.2020)