The Change Control Process (CCP) is an important part of our Quality Management System (QMS). It is designed to make sure that every change in documents, processes, systems, or equipment is properly reviewed and approved before it is implemented. Impact assessment is conducted thoroughly and finalized only after review and approval, prior to implementation of the change.
In change control pharma, it is critical to follow regulatory guidelines and maintain complete records of every step. Our CCP solution makes this easier by giving you a simple and structured way to manage changes, track progress, and stay compliant.
Key Features
Complete lifecycle control – Handles the full flow of change control from creation to closure.
Integration with QMS modules – Works smoothly with DocsExecutive™ (DMS) and eTraining.
Web-based access – Secure, reliable, and easy to use from anywhere.
Regulatory compliance – Supports electronic signatures and audit trails as per 21 CFR Part 11 (USFDA).
Default department mapping – Automatically loads impacted departments based on product type or category.
Action points for HODs – Each Head of Department can add action items with target dates.
Smart reminders – Automatic emails and notifications for tasks like review, approval, and impact analysis.
Easy monitoring – Site QA can track and monitor CCP progress with multiple tracking options.
MIS reports – Clear department-wise and location-wise analysis for better decision-making.
Provision of Discussion Forum – Department can interact and discuss internally.
Questionnaire provision – Department-specific questionnaire within the CCP to facilitate structured impact assessment.
Flowchart
CCP in Pharma
Using a change control form in pharma, users can record details about the change, link related documents, assign responsibilities, and track approvals. Our CCP module ensures all changes are transparent, well-documented, and compliant with industry regulations.
This reduces risk, saves time, and increases accountability across departments.
