Top 8 Change Management Solutions that can considered and implemented.

A compliance-focused change management solution should: consider the following solutions

1. 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.
2. 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.
3. Change management system of the organization should be scalable and has capacity to handle complex changes when necessary.
4. 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.
5. Track and monitor changes in the organization as they are executed and verified.
6. Effectiveness of change should be measured holistically at all levels.
7. Integrate with other departments regarding new changes to be implemented and provide additional trainings and certifications.
8. 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)