Change Control Process is an inter departmental collaborated process of implementing change in the product development / manufacturing or packaging. Change in product information needs to be well managed with proper coordination as each department of the organization is dependent on informations provided by other departments.
A complete cycle of Change Control Request Cycle needs to be executed for approvals by all departments before a change is executed on a product. The entire Change Control Process can be automated by using SoluSoft Document and Workflow Management Solution.

Below is the ideal scenario of Change Control Process followed in an organization.

Change Control Model

• An initiator from a local office initiates a change control by filling in: product name, product batch, change description, change type, department, export or domestic market, code number, present status, change justification, etc. At this point any original and revised product documents that are needed for change control are uploaded as attachments. This process creates a case for the change control and is routed to QA head
• The Quality Assurance(QA) head from the local office is then assigned to process the following tasks: change evaluation, adequacy of justification, feasibility of change, impact on quality, impact on production, validation requirement, stability requirement, trail requirement, change classification (major, minor).  At this point, the change is either rejected or approved. For approved change, actions are assigned to responsible persons with a target date for change completion.
• Some of the change may require technical committee approval at corporate head office. The technical committee consists of head of R&D, head of manufacturing, head of regulatory compliance, head of advance lab, head of corporate QA. In addition to these committee members, other department may be invited to participate during the collaboration. At this point, the change is either rejected or approved. For approved change, actions are assigned to responsible persons with a target date for change completion.

Business Objectives satisfied by the solution

• Provide streamlined change control process system that deals with complete life cycle of change from initiation through reviewing, verification, recording, approving and completion
• Provide change control process implementation per FDA 21CFR Part 210-211 compliance
• Need enterprise wide centralized system that enforces change control collaboration between local offices, head office, partners and suppliers
• Need web based centralized system that is secured and remotely accessible by personnel from local offices, personnel from head office, partners and suppliers
• Utilize single tool instead of multiple disparate tools to process change control using task assignment, deadline, alerts, escalation, scheduling, collaboration, discussion, routing and version control
• Provide audit trail to record change at every step
• Provide real time and statistical reports for change control tasks

 Major CCP Application Features

1. Case creation: Change control case creation can be manually initiated  or can be automated via scheduler
2. CCP Process: Streamlined change control process system that deals with complete life cycle of change from initiation through reviewing, verification, recording, approving and completion
3. Case Process: Task assignment, deadline, alerts, escalation, scheduling, collaboration, discussion, routing and version control
4. Reporting: Real time and statistical reports for change control activities