Change Control FAQs

Why Is It So Important to Have a Coordinated Change Control System in your QMS?

A change control system enables all documented changes to be properly coordinated across all relevant departments throughout the entire change control process.  Without a coordinated change control system, users could introduce changes that may disrupt operations or undo previously submitted changes requested by someone else in a different department. In addition, implementing a change control system, can improve transparency, so all users can see what changes have been requested, their status, and who is responsible for completing the workflow.

What Are the Steps Required to Make a Change in a Structured Change Control System?

In general, there are several steps that must happen before a change request can be implemented:

  1. Initial request
  2. Pre- approvals,
  3. Change execution
  4. Follow- up approvals
  5. Implementation
  6. Storing change history for audit

At each of these steps, there may be personnel from different departments that may need to get involved. In addition, the change may require regulatory filing and approvals and quality processes that must be addressed before the change can take place. This is where a change control solution like Sparta Systems’ can help project managers organize all tasks needed to complete the change as well as provide transparency needed across all of the departments that are affected by the change.

What Industries Does Sparta Systems Support?

Sparta Systems’ change control solution is a highly customizable system that was designed to be flexible enough to organize all types of changes in one platform. It does, however, support FDA compliance requirements for manufacturing quality production and a number of other regulatory standards and industry best practices. The system has been implemented by companies in a wide variety of industries to help them better address production issues, adverse quality events, and compliance requirements. In particular it has been implemented for businesses in the pharmaceutical industrymedical device industry, and more. 

What Are Some of the Features You Should Be Looking for in Change Control Solution?

Companies invest in change control systems because they need to be able to manage change at every level of the supply chain to ensure quality standards and compliance requirements are not affected. An optimal change control system will create a holistic system that eliminates any miscommunications and interdepartmental concerns. When a change is requested, all pertinent users can view the request, determine whether or not there is any risk involved, and come up with a plan for how the change can be carried out.

The solution should be able to handle every type of change request, including Batch, Documentation, EH&S, Equipment, Hardware/network, Materials, Packaging/labels, Process, Regulations, Specifications, Supplier, Validation. The change control system should also enhance transparency, improve regulatory reporting, and optimize management of change requests throughout the supply chain. Finally, change control systems should provide a checks and balances system to ensure the right changes are being made.

Is Sparta Systems’ Change Control Solution Right for My Organization?

Organizations looking to enhance the quality of their products, prevent a recall or other adverse event that can affect their bottom line and brand reputation, and ensure regulatory compliance can benefit from implementing Sparta Systems’ change control solution. The system facilitates perpetual improvement through organized change management. It is easy to use, highly configurable, and supports a closed loop system. Organizations are encouraged to contact us today to learn more about how our change control solution can help them mitigate risk, reduce waste, and improve collaboration.

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