Document No

STANDARD OPERATING PROCEDURE [Document Number]

<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Incident Management [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.

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 Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Incident and Problem Management [Effective Date]

Contents
1.0 PURPOSE .............................................................................................................................. 3
2.0 SCOPE .................................................................................................................................. 3
3.0 DEFINITIONS ........................................................................................................................ 3
3.1 Acronyms ......................................................................................................................... 3
3.1.1 IT – Information Technology ................................................................................... 3
3.1.2 SOP – Standard Operating Procedure ..................................................................... 3
3.1.3 QA – Quality Assurance ........................................................................................... 3
3.2 Terms ............................................................................................................................... 3
3.2.1 Incident .................................................................................................................... 3
3.2.2 Problem ................................................................................................................... 3
3.2.3 Requestor ................................................................................................................ 3
4.0 RESPONSIBILITY ................................................................................................................... 4
4.1 IT Manager, representative or designee ......................................................................... 4
4.2 Personnel ......................................................................................................................... 4
4.3 QA Representative........................................................................................................... 4
5.0 PROCEDURE ......................................................................................................................... 4
5.1 Reporting ......................................................................................................................... 4
5.2 Confirmation.................................................................................................................... 4
5.3 Investigation .................................................................................................................... 5
5.3.1 Determine root cause .............................................................................................. 5
5.3.2 Contact 3rd Party ...................................................................................................... 5
5.4 Resolution ........................................................................................................................ 5
5.5 Close out .......................................................................................................................... 6
5.6 Periodic Review ............................................................................................................... 6
6.0 REFERENCES ........................................................................................................................ 6

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 Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Incident and Problem Management [Effective Date]

1.0 PURPOSE
The purpose of this procedure is to define the requirements to ensure that any unplanned
Information Technology (IT) incident that could impact product quality and data integrity is
addressed in order to minimize the disruption of operational activities.
The process defined within this procedure is also designed to return the system or service to
users as quickly as possible.
Commented [MTM1]: In this section, you should insert a short
statement describing the purpose of the procedural document to
describe why it is needed, and what it is being implemented to
accomplish.
If the text in Section 1 is acceptable, you need only insert your
Company name to replace the italicized field.

2.0 SCOPE
This procedure applies to operational systems in use by Company Name.
This procedure does not apply to the management of incidents governed by the following
procedures:
• Nonconformance <enter appropriate procedure reference>
• CAPA <enter appropriate procedure reference>
• Deviation <enter appropriate procedure reference >
Commented [MTM2]: In this section, you should insert a short
statement describing the scope of the procedural document,
outline the reason the document was created and define its
intended audience.
If the text in Section 2 is acceptable, you need only insert your
Company name to replace the italicized field.

3.0 DEFINITIONS Commented [MTM3]: 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 SOP – Standard Operating Procedure
3.1.3 QA – Quality Assurance
3.2 Terms
3.2.1 Incident
An issue that has impaired services.
3.2.2 Problem
An issue that has not caused interruption or degradation to services.
3.2.3 Requestor
Person who initiated or reported an incident or problem.

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 Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Incident and Problem Management [Effective Date]

4.0 RESPONSIBILITY Commented [MTM4]:

4.1 IT Manager, representative or designee

4.2 Personnel

4.3 QA Representative

5.0 PROCEDURE
5.1 Reporting

5.2 Confirmation

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 Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Incident and Problem Management [Effective Date]

5.3 Investigation

5.3.1 Determine root cause

5.3.2 Contact 3rd Party

5.4 Resolution

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 Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Incident and Problem Management [Effective Date]

5.5 Close out

5.6 Periodic Review

6.0 REFERENCES
Document Number Document Title

N/A

Document Number [Add document title of documents referenced within]

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