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APPROVALS:
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REVISION HISTORY:
Revision Initials and Date Summary of Changes
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- Montrium has inserted instructions in blue text into this document to help you
understand the information in each section. Once you have modified this
document to meet the specifics of your organization, please delete the blue text.
- Blue italicized text in this document indicates elements which should be revised
or completed by you so that the text meets your company’s needs and quality
system requirements. Once you have completed this information, please remove
the italics in the document.
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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
System Change Control [Effective Date]
1.0 PURPOSE Commented [MTM1]: In this section, you should insert a short
statement describing the purpose of the procedural document to
The purpose of this procedure is to define a formal process for change management that will describe why it is needed, and what it is being implemented to
accomplish.
ensure that system changes are implemented in a controlled fashion. The procedure will also
describe the framework for proposing, reviewing, and approving changes to a system.
2.0 SCOPE Commented [MTM2]: In this section, you should insert a short
statement describing the scope of the procedural document,
This procedure applies to changes intended for Company Name validated information outline the reason the document was created and define its
intended audience.
technology systems that are in operational use.
If the text in Section 2 is acceptable, you need only insert your
The following changes are exempt from this procedure: Company name to replace the italicized field.
• Changes to non-regulated systems Commented [MTM3]: You must describe or reference how
these are handled (i.e. these changes are handled through regular
• Like-for-like replacements maintenance defined within the System Maintenance SOP)
• Emergency Changes
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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
System Change Control [Effective Date]
4.2 Personnel
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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
System Change Control [Effective Date]
5.0 PROCEDURE
5.1 Change Management Commented [MTM6]:
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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
System Change Control [Effective Date]
(a)
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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
System Change Control [Effective Date]
5.2.6 Closure
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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
System Change Control [Effective Date]
Confidential Page 7 of 8
Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
System Change Control [Effective Date]
6.0 REFERENCES
Document Number Document Title
Document Number
Document Number
Document Number
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