Organizations must continue to evolve and with that comes a level of change—don’t let fear of change hold you back. Automating the process helps to ensure a successful outcome. An automated change control process enforces standardized change across the enterprise while allowing the flexibility to meet specific workflow steps, making it flexible enough to manage various types of changes using one centralized system.
This process is applied to ensure that changes in a system or product are controlled, coordinated and approved before their implementation.
Here’s why it’s needed.
The Importance of Change Control
To prevent issues associated with changes to processes and procedures, systematic controls must be put in place. For any company with a complex manufacturing process, systems must be established to evaluate changes and to track them. This ensures adequate control.
Change control is critical because:
- Every modification to a process, material or equipment needs to be properly recorded and authorized
- It ensures proper coordination across stakeholders through automated workflows and alerts
- It helps meet compliance with industry and government regulations and standards
Change control ensures the safety and quality of medicines are not compromised by production and process changes. With the lives of consumers at stake, product irregularities simply cannot occur.
Challenges Facing Manual Change Control
There are various types of changes that can trigger the change control process, including changes to documents, regulations, equipment and materials.
The vast and complex nature of change control procedures has caused many companies to struggle with implementing a global change management system.
As a result, many manufacturers instead use a collection of disparate manual systems, spreadsheets and databases. These manual, disconnected mechanisms can lead to delays, input errors, inconsistencies, duplicate data and loss of productivity.
Benefits of Automating the Change Control
An automated change control system manages all action items associated with a change including impact assessments, implementation items, regulatory notifications, approvals and effectiveness checks. It reduces risk by enforcing a consistent and harmonized change control process that is compliant with industry regulations.
Organizations will also see an improvement in efficiency and reduction in change control closure time by automating workflows and implementing an electronic parallel review and approval process. Furthermore, the process reduces risk of lost or duplicated data by enforcing a consistent and harmonized change control process.
3 Best Practices to Follow for Effective Change Control
Change control is a critical business issue in terms of risk, safety and business performance. Successful implementation of an enterprise-wide global change control program will:
- Improve cycle time and time to market
- Enhance production
- Increase product quality
- Enable flexibility needed to adapt to changing regulations
There are three best practices companies can apply that will provide an effective change control system—automation, centralization and integration.
View the eBook to learn more about these best practices and learn how they can transform your change control process.
