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MasterControl Change Control™
Just as with life in general, the only constant in quality management and business is change. In FDA and ISOenvironments, change control is required as a way of improving product quality and safety — and ensuring compliance.
How can MasterControl help you?
MasterControl Change Control ™ is designed to automate and effectively manage every step of the change control process,
from submission through actual implementation, verication, and close of project.
MasterControl offers a line of validation products and services addressing different levels of validation needs based on individualrisk assessment. They are designed to allow “continuous validation” for FDA-regulated companies by making validation of software upgrades easier, faster, and more cost-effective
Here’s how MasterControl can ease some of the major challenges in change control:
Communication breakdownis likely to happen in a quality management system thatconsists of disconnected tools and processes. In thecontext of change control, this could mean lack of follow-
up, late notications, and delays in task completion.
MasterControl is an integrated solution thateffectively connects users, data, and processes under a centralized system. This connectivity vastly improves
communication and efciency, and helps ensure that
issues don’t fall through the cracks.
Timeliness is essential in changecontrol. A manual system that relies on paper-baseddocuments to generate necessary data, and legworkto route and track submissions is likely to have poor turnaround for change implementation.
Integrates and streamlines theentire change control process for faster turnaround. Itoffers a best-practice form that incorporates priority level,as well as escalations. Plus, reports provide real-timestatus for all change control tasks.
Training not Integrated with Change:
In a manual
system, it is difcult for employees to keep up with
all the changes in SOPs, policies, and other criticaldocumentation because the training process is notconnected to the rest of the quality system.
With MasterControl, the changecontrol process can be integrated with training control. Anychange to a document/process that warrants new trainingwill automatically invoke training tasks.
MasterControl allows continuous compliance by keeping your quality system always ready for inspections andaudits.
Automates all tasks pertaining to change control, including routing, notication, follow-up, escalation,
and approval. Automation helps simplify the compliance environment, making it easier to stay compliant.
A pre-congured, multi-page form helps collect and track data throughout the change control process.
A section in the change submission form captures such information as description of change, justication, and
impact. Both original and revised documents can be attached for easy comparison.An initiator can use one form for multiple changes. For example, the form for a change in a component used inmaking 10 products can have 10 attachments, greatly streamlining the process.