MasterControl Change Control™

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 MasterControl Solution

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 follow-
up, late notifications, and delays in task completion.
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.

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.
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.

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.
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.

• 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.

web: www.mastercontrol.com phone: 800.825.9117 email: info@mastercontrol.com

 MasterControl Change Control™

• 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.

© 2010 MasterControl Inc. All rights reserved.

SKU: M1240 REV: 0010

web: www.mastercontrol.com phone: 800.825.9117 email: info@mastercontrol.com