Compliant. Connected. Complete.

Tech Paper:
MasterControl Change Control™

Managing Change to Ensure Compliance

Introduction
Since it’s impossible to avoid change, it is absolutely critical for regulated companies to manage it. In the FDA and
ISO environments, change must be controlled to prevent unintended consequences in the manufacture of products. Any
“unintended consequences,” for example, in a surgical balloon used to open blocked arteries of heart patients, or in a
tire used in millions of cars worldwide, could have a great impact on public safety. The concept of change control is so
crucial that it has been incorporated in a number of regulations enforced by the Food and Drug Administration and in ISO
international standards.

In manufacturing, change refers to any modification in equipment, raw materials, facilities, utilities, design, formulations,
processes, packaging/labeling, computer systems, and all associated documentation (SOPs, quality manual, etc.). A
change may refer to an updated document, or a simple part replacement, or a totally revamped design. A change may be
temporary or permanent, routine or emergency, simple or serious enough to shut down production. It may be caused by a
deviation from an approved regulatory filing or written procedures.

Regulatory Requirements
The FDA’s 21 CFR Part 820 requires medical device manufacturers to establish written change control procedures.
Specific requirements are outlined in section 820.30 (design changes), section 820.40 (document changes), and section
820.70 (production and process changes).

Written procedures are considered part of the Current Good Manufacturing Practice regulations (CGMP) outlined in 21
CFR Parts 210-211, which cover drug and biologic manufacturers. Section 211.100 provides that written procedures,
including any changes, should be controlled — meaning recorded, reviewed, and approved by the quality control unit.
Any deviation from written procedures should be recorded and justified.

Manufacturers certified to ISO 9001:2000 and ISO 13485 standards face similar requirements. They are required to ensure
that any changes affecting the quality management system (including product requirements, design, and development
changes) should be controlled. Changes must be reviewed, verified, validated, and approved prior to implementation.

Manual or Hybrid Quality System

Change control is a complex process and an inadequate system can cause internal confusion, noncompliance, or even a
product recall or liability lawsuit. Change control can be especially challenging for companies that rely on a paper-based
or hybrid process. Here are some of the characteristics of manual and hybrid systems and the common problems they
cause.

• Inefficient System – Under a paper-based system, companies are likely to rely on face-to-face exchanges,
such as change control board meetings, to discuss changes. The effectiveness of these meetings depends on
their frequency and the availability of members to meet as emergency changes arise. Lack of communication
between departments, failure to follow up or escalate change requests, and delayed or inappropriate
notification of changes made by suppliers are all symptoms of an inefficient system.

• Disconnected Processes – Quality processes that are not connected, as in manual and hybrid systems, are
likely to result in a communication breakdown. In the context of change control, this could mean lack of
follow-up, late notifications, and tasks not completed by deadline. Suppliers who are entirely outside the
change control process could be making changes without proper and timely notification.

• Time Consuming – Finding the necessary data in a manual process almost always requires more time and
effort, and could result in poor turnaround for change implementation. The problem becomes worse when
there is an unexpected change — a deviation — and supporting data is not generated in a timely manner.
Delays may also result from failure to recognize the urgency of a change and the absence of a contingency
plan for certain types of changes.

MasterControl Change Control™ Page  Tech Paper

 Figure 1 - MasterControl connects change control with training processes to automatically
invoke training tasks when a document or process requires change

• Ineffective Documentation – A manual system could mean ineffective documentation unless employees are
vigilant in revising and updating documents. For example, a proposed change may be delayed if an outdated
record does not show revision history, or testing may be duplicated because documentation has not been
updated with results of a previous testing.

• Training not Integrated with Change – Adequate personnel training on approved changes is a prerequisite
in both FDA and ISO environments. In a manual system, training control is not connected to change control
and other quality processes. Training tasks can easily fall through the cracks, unless employees actively seek
them.

The MasterControl Solution

MasterControl Change Control™, an integrated part of the MasterControl™ quality management suite, automates and
manages the change control process in an efficient and cost-effective manner. Here is how MasterControl addresses major
challenges in change control.

Sustained Compliance: MasterControl helps FDA-regulated and ISO-certified companies attain and sustain compliance
by optimizing the change control process and keeping the overall quality system always ready for inspections and audits.

• Increased Efficiency - MasterControl automates all tasks pertaining to change control, including routing,
follow-up, escalation, and approval. Automation helps simplify the compliance environment, making it easier
to stay compliant.
• Centralized Repository - All documents related to change control will be stored in a secure, centralized
repository, making it easy to update, or search and retrieve them.

MasterControl Change Control™ Page  Tech Paper

 Figure 2 - Electronic “Best Practice” forms provide a medium for collecting
and tracking data throughout the change control process

• Best-Practice Process - A pre-configured, multi-page form guides users through the process of collecting and
tracking data from submission through evaluation, approval/rejection, implementation, verification, and close
of project.

• 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, depending on how many documents/items are
affected by a change. 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. For FDA-regulated companies, 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.

MasterControl Change Control™ Page  Tech Paper

 Figure 3- A variety of reports help proactively manage the change control process

• Analytics and Reporting - MasterControl’s advanced analytics and reporting capability increases
management oversight. It provides the ability to dynamically capture, trend, and link data needed to solve
problems and improve processes. Data can be summarized in multiple levels, so change orders can be
reported by product, department, root cause, etc.

• Revision Control - MasterControl automatically provides revision history through the InfoCard, the
MasterControl tool that provides basic information for every record. The software also provides the
document’s approval history. All changes made to the InfoCard are tracked, including reason(s) for every
change.

• Solid Audit Trail - For companies covered by the FDA’s 21 CFR Part 11, MasterControl provides a secure,
time-stamped audit trail as required by the regulation. The software documents the identity of anyone who
creates or modifies an electronic record, when the action occurred, and the changes made.

• Validation Services - To help companies meet 21 CFR Part 11’s validation requirements, MasterControl
provides IQ, OQ, and PQ validation protocols, tests, and consulting services. It continuously develops new
methods to cut the time involved in validating a system and to make it easier to validate software upgrades,
both of which are essential in lowering overall validation cost.

MasterControl Change Control™ Page  Tech Paper

Integrated Quality Management Suite: MasterControl connects the change control process with other quality processes
for a holistic approach to quality management.

• Easy Access - MasterControl is Web-based so it can connect employees, suppliers, contractors, consultants,
and others involved in the change control process regardless of location.

• Form-to-Form Launching - A change submission form can be launched directly from another form, such as
a corrective/preventive action (CAPA) form. Pertinent information from the CAPA form will be automatically
entered into the change submission, reducing data entry and mistakes common in manual data entry. Links are
maintained so users can review a completed process and see what triggered the change.

• Integrates Training with Change Control - With MasterControl, 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. MasterControl can automate the process of distributing online exams as
well as grading.

• Dependent Routing - Completion of a task can be made dependent on another task to give managers
more control of the workflow and reduce cycle time by prompting users immediately to their next task. An
innovative dependency tree illustrates relationships between dependent processes.

Enterprise-wide Solution: MasterControl can handle every department’s forms- and documents-based processes, making
it an ideal enterprise-wide solution.

• Integrates with Other Applications - MasterControl can integrate with other applications like ERP, LIMS,
accounting, and human resources applications to accommodate departmental needs.

• Easy to Search - A standardized Google-like search window is available throughout the application, which
means all authorized users throughout the organization can search and retrieve change control-related tasks
and documents.

• Easy to Find - MasterControl’s Organizer, similar to Windows Explorer, is an easy-to-use tool that helps
users find and access documents quickly. Every department can maintain its own Organizers and documents
can be stored in multiple Organizers. System administrators can control and automatically update the
documents through a dynamic link in the InfoCard.

• Automation of Forms-Based Processes - Any forms-based process unique to a department (i.e., PTO
forms for HR, customer satisfaction survey forms for Customer Service Department) can be automated. A
department can keep the look and function of existing forms or create entirely new ones.

Conclusion
FDA regulations and ISO standards emphasize the importance of implementing changes according to approved written
company policies and procedures. In this context, approval implies thorough review, investigation, and successful testing
to make sure that the change works. An effective change control system will help prevent unauthorized modifications that
could lead to noncompliance, or worse, expensive product recalls and product liability lawsuits.

Regulated companies can greatly benefit from software solutions that automate, streamline, and manage the change
control process. It makes good business sense to take advantage of the latest technology to optimize the change control
process, not only to help ensure compliance but as a tool for continuous quality improvement.

MasterControl Change Control™ Page  Tech Paper

About MasterControl Inc.
MasterControl Inc. has been at the forefront of providing quality management software solutions since 1993. Hundreds of
companies worldwide use MasterControl to help ensure compliance with FDA regulations such as 21 CFR Parts 11, 210-
211, 820, 606; ISO quality standards such as ISO 9000, ISO 13485, ISO 14000; and Sarbanes-Oxley Act requirements.
In addition to providing off-the-shelf products, MasterControl also offers comprehensive technical and customer support,
including product training, implementation, and validation services.

For additional industry white papers about automating quality and regulatory processes, visit www.mastercontrol.com,
or call, 800-825-9117.

© 2006 MasterControl Inc. All rights reserved.

MasterControl Change Control™ Page  Tech Paper

MasterControl Inc.
6340 S. 3000 E. Suite 150
Salt Lake City, UT 84121

P. 800.825.9117
F. 801.942.7088
www.mastercontrol.com