Compliant. Connected. Complete.

MasterControl Change Control™
Just as with life in general, the only constant in quality management and business is change. In FDA and ISO environments, 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, verification, and close of project. MasterControl offers a line of validation products and services addressing different levels of validation needs based on individual risk 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:

Challenges Disconnected Processes: Communication breakdown is likely to happen in a quality management system that consists of disconnected tools and processes. In the context of change control, this could mean lack of followup, late notifications, and delays in task completion. Poor Turnaround: Timeliness is essential in change control. A manual system that relies on paper-based documents to generate necessary data, and legwork to route and track submissions is likely to have poor turnaround for change implementation. Training not Integrated with Change: In a manual system, it is difficult for employees to keep up with all the changes in SOPs, policies, and other critical documentation because the training process is not connected to the rest of the quality system.

MasterControl Solution Connected: MasterControl is an integrated solution that effectively connects users, data, and processes under a centralized system. This connectivity vastly improves communication and efficiency, and helps ensure that issues don’t fall through the cracks. Excellent Turnaround: Integrates and streamlines the entire change control process for faster turnaround. It offers a best-practice form that incorporates priority level, as well as escalations. Plus, reports provide real-time status for all change control tasks. Integrates Training: With MasterControl, the change control process can be integrated with training control. Any change to a document/process that warrants new training will automatically invoke training tasks.

Compliant: : MasterControl allows continuous compliance by keeping your quality system always ready for inspections and audits. • • Automates Tasks: Automates all tasks pertaining to change control, including routing, notification, follow-up, escalation, and approval. Automation helps simplify the compliance environment, making it easier to stay compliant. Best-Practice Form: A pre-configured, 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, justification, 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 in making 10 products can have 10 attachments, greatly streamlining the process.

6322 S. 3000 E. Suite 110 Salt Lake City, UT 84121

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Compliant. Connected. Complete. ™
• The initiator is asked to evaluate the change in terms of training, validation, and regulatory requirements, prompting risk assessment. It also asks for classification of the change as low, medium, and high. Any high-level change implies great impact on the product and is likely to require regulatory filing. The ability to prioritize is incorporated because the form asks the initiator to categorize the change submission as routine or temporary or emergency.

• • •

Revision Control: Provides automatic revision history through the InfoCard, the MasterControl tool that summarizes basic information for every record. All changes made to the InfoCard are tracked, including reason(s) for every change. Analytics and Reporting: Provides standard and customized reports. Data can be summarized in multiple levels, so change orders can be reported by product, department, root cause, etc. MasterControl’s advanced analytics and reporting capability includes dashboard, drill-down, and scheduling features. Part 11-Compliant Features: Provides time-stamped audit trail, reporting, and electronic signature capabilities that fully satisfy FDA’s 21 CFR Part 11 requirements. Security features include dual passwords for document approval; password expiration, encryption, and certification; and account lockout to stop unauthorized users from gaining system access.

Connected: MasterControl connects the change control process with other quality processes to promote continuous improvement. • • • Web-based Platform: MasterControl is Web-based so it can connect all users involved in change control from virtually anywhere. Integrates with Existing Repositories: Integrates with existing document repositories and enterprise applications like ERP, LIMS, etc., without expensive custom coding. Form-to-Form Launching: A change submission form can be launched directly from a corrective/preventive action (CAPA) form, connecting one process to the next. MasterControl maintains the links so one can review a completed process and see what triggered the change. Relevant information from the CAPA form will be automatically entered into the change submission form. Integrates Training: The change control process can be integrated with training control. Any change to a document or process that calls for new training will automatically invoke training tasks. Automates the process of distributing online exams and grading. Organizers: MasterControl’s Organizer, similar to Windows Explorer, is an easy-to-use tool that helps users find and access documents quickly. All documents related to a particular change can be grouped together in Organizers.

Complete: MasterControl offers robust software, plus the appropriate tools and services necessary for successful implementation and validation. • Continuous Validation: For FDA-regulated companies, MasterControl offers a “continuous validation” approach that dramatically cuts the time, pain, and cost involved in validation. MasterControl’s continuum of innovative products and services include MasterControl Transfer OQ and MasterControl Automated OQ. Product Training: MasterControl’s Professional Services team, consisting of former ISO auditors and system administrators, has developed a comprehensive training program that serves as a foundation for successful project implementation and helps companies realize software ROI faster. Technical Support: Choosing MasterControl means getting the necessary technical support to ensure project success. MasterControl offers the expertise, infrastructure, and flexibility to meet every customer’s needs, from initial installation to regular maintenance.

6322 S. 3000 E. Suite 110 Salt Lake City, UT 84121

P 800.825.9117

F 801.942.7088

MASTERCONTROL.COM

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