Change Control

Whitepaper:  Enterprise Change Control - A Life Science Business Imperative

Sparta Systems' change management solution enables all documented changes to be properly coordinated while increasing transparency by managing the change control process across all relevant departments from initial request, through pre- approvals, change execution, follow- up approvals and implementation.  

In addition, the change request management process will organize all tasks and activities tracked including actions needed to complete the change, regulatory approvals and updates as well as the appropriate linkages to other quality and regulatory processes including CAPA and product registration tracking. 

This change control software solution enforces a standardized change control process across the enterprise while allowing the flexibility to meet specific workflow steps, making it the only change control software solution designed to be flexible enough to manage all types of changes using one centralized system.

The Importance of Managing Change from a Change Request 

A change request usually consists of a document that contains a need for an adjustment of a system or process; it is the key element in change request project management.  Change requests are declarative, stating what needs to be accomplished, but leaves out how the change should be carried out. The change management system helps you document every detail of a change request.  

Justifying the Investment in Change Management Software

By documenting changes when they occur, you maintain control over the changes made throughout the enterprise, which helps reduce your businesses' exposure to a loss of quality. Sparta Systems' change management solution keeps a running workflow so that management and quality professionals can evaluate the risk involved with a particular change and plan accordingly. So even when unplanned change requests occur, Sparta Systems' change management software can help keep your business' exposure to risk down.

Management of Change (MOC) Software Applications Include Areas Such as
Batch Documentation EH&S
Equipment Hardware/Network                     Materials   
Packaging/Labels              Process Regualtions           
Specifications Supplier Validation

Management of Change (MOC) Software Applications Include Areas

Controlling change requests in projects is vitally important and must be managed correctly to avoid potentially damaging your bottom line, putting customers at risk, and damaging brand reputation. When implemented and managed successfully, enterprise-wide global change control management software can improve and invigorate your business, enhance production and increase product quality. 

Read about Change Control Solutions for the Pharmaceutical and Biotech Industry 

Change Control Frequently Asked Questions

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