Data Sheet
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 Software Solutions 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 and Solutions
Challenges MasterControl Solution
Disconnected Processes: Communication breakdown Connected: MasterControl is an integrated solution that
is likely to happen in a quality management system that effectively connects users, data, and processes under
consists of disconnected tools and processes. In the a centralized system. This connectivity vastly improves
context of change control, this could mean lack of follow- communication and efficiency, and helps ensure that
up, late notifications, and delays in task completion. issues don’t fall through the cracks.
Poor Turnaround: Timeliness is essential in change Excellent Turnaround: Integrates and streamlines the
control. A manual system that relies on paper-based entire change control process for faster turnaround. It
documents to generate necessary data, and legwork offers a best-practice form that incorporates priority
to route and track submissions is likely to have poor level, as well as escalations. Plus, reports provide real-
turnaround for change implementation. time status for all change control tasks.
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Data Sheet
Training not Integrated with Change: In a manual Integrates Training: With MasterControl, the change
system, it is difficult for employees to keep up with control process can be integrated with training control.
all the changes in SOPs, policies, and other critical Any change to a document/process that warrants new
documentation because the training process is not training will automatically invoke training tasks.
connected to the rest of the quality system.
How Can MasterControl Help Your Organization?
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.
• 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.
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Data Sheet
• 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.
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Data Sheet
• 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.
About MasterControl
MasterControl Inc. creates software solutions that enable life science and
other regulated companies to deliver life-improving products to more people
sooner. MasterControl’s integrated solutions accelerate ROI and increase
efficiencies by automating and securely managing critical business processes
throughout the entire product lifecycle. More than 1,000 companies worldwide,
ranging in size from five employees to tens of thousands, rely on MasterControl
cloud solutions to automate processes for new product development, clinical,
regulatory, quality management, supplier management, manufacturing and
postmarket surveillance. MasterControl solutions are well-known for being
scalable, easy to implement, easy to validate and easy to use. For more
information, visit [Link].
© 2019 MasterControl Inc. All rights reserved.
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