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MasterControl Change Control™: Managing Change to Ensure Compliance

MasterControl Change Control™: Managing Change to Ensure Compliance

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Published by mastercontroldotcom
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.
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.

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Published by: mastercontroldotcom on Jan 06, 2011
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05/12/2014

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Tech Paper:
MasterControl Change Control™Managing Change to Ensure Compliance
Compliant. Connected. Complete. ™
 
MasterControl Change Control™PageTech Paper 
Introduction
Since it’s impossible to avoid change, it is absolutely critical for regulated companies to manage it. In the FDA andISO 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 atire used in millions of cars worldwide, could have a great impact on public safety. The concept of change control is socrucial that it has been incorporated in a number of regulations enforced by the Food and Drug Administration and in ISOinternational standards.
In manufacturing, change refers to any modication in equipment, raw materials, facilities, utilities, design, formulations,
 processes, packaging/labeling, computer systems, and all associated documentation (SOPs, quality manual, etc.). Achange may refer to an updated document, or a simple part replacement, or a totally revamped design. A change may betemporary or permanent, routine or emergency, simple or serious enough to shut down production. It may be caused by a
deviation from an approved regulatory ling or written procedures.
Regulatory Requirements
The FDA’s 21 CFR Part 820 requires medical device manufacturers to establish written change control procedures.
Specic 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 21CFR 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 justied.
 
Manufacturers certied 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, veried, 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-basedor hybrid process. Here are some of the characteristics of manual and hybrid systems and the common problems theycause.
Inefcient 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 ontheir 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
notication of changes made by suppliers are all symptoms of an inefcient system.
 
Disconnected Processes
– Quality processes that are not connected, as in manual and hybrid systems, arelikely to result in a communication breakdown. In the context of change control, this could mean lack of 
follow-up, late notications, and tasks not completed by deadline. Suppliers who are entirely outside thechange control process could be making changes without proper and timely notication.
 
Time Consuming
– Finding the necessary data in a manual process almost always requires more time andeffort, and could result in poor turnaround for change implementation. The problem becomes worse whenthere 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™PageTech Paper 
 
Figure 1 - MasterControl connects change control with training processes to automaticallyinvoke training tasks when a document or process requires change
Ineffective Documentation
 – A manual system could mean ineffective documentation unless employees arevigilant in revising and updating documents. For example, a proposed change may be delayed if an outdatedrecord does not show revision history, or testing may be duplicated because documentation has not beenupdated with results of a previous testing.
Training not Integrated with Change
– Adequate personnel training on approved changes is a prerequisitein both FDA and ISO environments. In a manual system, training control is not connected to change controland 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 efcient and cost-effective manner. Here is how MasterControl addresses major 
challenges in change control.
Sustained Compliance:
MasterControl helps FDA-regulated and ISO-certied companies attain and sustain compliance
 by optimizing the change control process and keeping the overall quality system always ready for inspections and audits.
Increased Efciency
- 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, centralizedrepository, making it easy to update, or search and retrieve them.

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