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Document No

STANDARD OPERATING PROCEDURE [Document Number]


<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
System Change Control [Effective Date]

APPROVALS:
Name Signature Date

REVISION HISTORY:
Revision Initials and Date Summary of Changes
00

Instructions on completing this document


(Please remove this table when you are finished modifying this document.
This table is for your information only.)

- 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.

Confidential Page 1 of 8
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

3.0 DEFINITIONS Commented [MTM4]: In this section define acronyms and


terms that would help team members better understand the
3.1 Acronyms content of this Procedure.

3.1.1 IT – Information Technology


3.1.2 QA – Quality Assurance
3.1.3 SCR – System Change Request
3.1.4 SOP – Standard Operating Procedure
3.2 Terms
3.2.1 Change
Any modification that must be planned for, evaluated, tested, documented, scheduled, and
authorised prior to use.
3.2.2 Controlled Environment
A controlled environment supports regulated activities and must be documented and
maintained following strict guidelines as defined within governing procedures (i.e. Configuration
Management and Change Control).
3.2.3 Emergency Change
Any change that requires immediate action in order to protect patient health and safety, to
protect critical business assets, or to resume critical business activity that has been interrupted.
3.2.4 Like-for-like Replacements
Replacement of a component with a component of equal functionality, generally built by the
same manufacturer and having the same model number, and which would have no effect on the
system.

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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
System Change Control [Effective Date]

3.2.5 Non-Controlled Environment

3.2.6 Turnaround Time (Recovery Turnover)

4.0 RESPONSIBILITY Commented [MTM5]:

4.1 IT Manager, representative or designee

4.2 Personnel

4.3 Quality Assurance Representative

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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]:

5.1.1 Like for Like Replacements

5.1.2 System Administration Changes

5.1.3 Emergency Changes

5.1.4 Temporary Changes

5.2 SYSTEM CHANGE CONTROL (SCR) PROCESS


5.2.1 Change Request Good Documentation Practices

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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
System Change Control [Effective Date]

5.2.2 Initiating a Change Request

5.2.3 Request Routing

(a)

5.2.4 System Change Request Management

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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
System Change Control [Effective Date]

5.2.5 Change Release into Production

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]

5.3 Risk and Impact Assessment Commented [MTM7]:

5.4 Change Implementation and Verification Commented [MTM8]:

5.5 Change Release Commented [MTM9]:

5.6 Change Documentation Archiving Commented [MTM10]:


.

5.7 Periodic Review

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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