STANDARD OPERATING PROCEDURE

Title: System Requirements

SOP Number: IT-003 SOP Revision: 002

Effective Date: 01-SEP-2019 Expiration Date: 31-AUG-2021
Review Date: 01-SEP-2020 Primary Author: Chris Williams

SOP Coverage
Departments: Information Technology
Locations: United States, Canada
Subsidiaries: All
Job Titles: All

Approvers
Name Title Date Signature

Related Information
Related IT-001 SDLC Overview
Documents: IT-002 User Requirements
Related 21 CFR Part 11, Sarbanes-Oxley Act of 2002
Regulations:
Related Systems: All

Revision History
Revision Number Summary of Changes
001 Initial version
002 Added summary steps and flowchart

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Table of Contents

Purpose.................................................................................................................................................3
Steps .....................................................................................................................................................3
Related Documents ..............................................................................................................................7
Related Regulations..............................................................................................................................7
Related Business Systems.....................................................................................................................7
Appendix C - Summary Steps................................................................................................................8
Appendix B - Workflow Diagram ..........................................................................................................9
Appendix C – Additional Attachments................................................................................................10

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 Standard Operating Procedure Details

Purpose
The purpose of this document is to provide a detailed template and instructions for creating a Standard
Operation Procedure (SOP) document. This template can be used for any SOP in any situation. The
steps outlined document.

Steps

1. Complete the required identifying information for the SOP.

Each SOP needs unique identifiers, the areas of the organization that fall under the SOP, an
approver list and revision history. Whether all this information is at the beginning of the SOP
(recommended) or end, it is important that it is consistent. The following information is needed
for each SOP.

Title: Unique descriptive title for the SOP.

SOP Number: Unique identifier for SOP. Typically, an SOP Number consist of an acronym to
represent the category of the SOP (e.g. QA – Quality Assurance, IT – Information Technology),
plus a sequential number. QA-005, IT-002, CLIN-003, FIN-002, HR-007

SOP Revision: Unique sequential number indicating the current revision of the SOP document.
It is very common for SOPs to be modified over time. Each revision made to an existing SOP
needs a unique revision number. Recommended format for revision numbers is a three-digit
number format. e.g. 001, 002, 003. NOTE: Only one revision can be active at a time.

Effective Date: Start date the SOP becomes active and governance period begins.

Expiration Date: As part of any compliance framework, SOPs (and policies) cannot perpetually
exist and must have an expiration date. This prevents old or stale SOPs accidentally kept in
place. Of course, if the SOP is still valid at the time of the expiration date, it can be re-issued
with new dates. Typical time expiration periods are two(2) years.

Review Date: A review date occurs between the Effective Date and Expiration Date of an SOP.
The review date indicates when a review is completed to insure the SOP is still valid in the
current form. The review can be completed by approvers, process owners or the primary
author. It is common to have all SOPs reviewed on an annual basis.

Primary Author: The main individual responsible for making edits to the SOP.

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2. Complete the SOP Coverage information

SOP Coverage indicates which parts of the organization fall under the SOP, who needs to be in
compliance, who needs to be trained and who needs to be informed of changes.

Although it is possible to structure this section in any manner, the following categories are
generally recommended for mid-sized to large organizations:

a. Department/Division
b. Geographic Location
c. Legal Entity/Subsidiary
d. Job Title

3. List the SOP Approvers

Section that lists the approvers and is also used if physical signatures are being used instead of
digital signatures.

4. Complete Revision History

Revision history provides a summary of changes made to an SOP for the current revision. The
revision history provides readers of the SOP a quick review of what actually changed from the
previous version. Revision history is also used extensively by Quality Assurance, Corporate
Compliance and Internal Audit during reviews and testing.

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5. Document the detailed steps of the SOP

The detailed steps are the core content of any SOP. Detailed steps provide the specific actions
that need to be performed and who needs to complete them. Although, the actual structure of
an SOP step can change from organization to organization based on the needs, there are several
common components that should also be completed. It is also critical that each step is
numbered for proper reference.

Step Title: Brief description of the step that can be quickly referenced. Steps titles should
begin with an action verb.

Details: Detailed description of the step. This can include text, images, illustrations or
even videos. The details of the step must provide the reader all the information needed to
properly complete the step.

Step Owner: Indicates who needs to complete the current step.

Next Step: As some steps may create a decision point or create different output that needs
to be handling differently, it may be important to include a next step. For example, if Step 5 is a
review and the reviewer rejects the content, the SOP may need to go back to Step 2 instead of
proceed to Step 6.

6. List Related Documents (Optional)

Related documents are SOPs or Policies that have references to the current SOP or vice versa.
Most SOPs are governed by specific Policies in an organization. A change in a Policy may force a
change to an SOP or at the very least should be reviewed. This can also be found with
connected SOPs. If the output of one SOP changes, any other SOP that uses that SOP should
also be reviewed for changes.

Related Documents is one of the most important yet overlooked components of an SOP.
Without proper Related Document tracking and usage, the changes of introducing risk or errors
into your process is very high.

7. List Related Regulations or Standards (Optional)

In most instances, if a formal SOP is being created, the process is in a regulated environment
and subject to direct audit. It is recommended to list the specific regulations or standards that
govern your SOP. Providing Related Regulations and Standards provides an Auditor guidance for
the SOP. It also provides a list of SOPs that need to be reviewed if there is a change in a
Regulation or Standard.

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8. List Related Business Systems or Equipment (Optional)

Anytime an SOP incorporates Steps that involve a specific business system or piece of
equipment, it needs to be listed for quick reference and audit. In the event there is a change in
a Business System (eg. new Time System, new CTMS) or piece of equipment, any SOP that has
reference needs to be reviewed for changes. Without a link between an SOP and business
systems or equipment, the changes of a broken SOP increased dramatically when a change is
introduced.

9. Complete Summary Steps

Summary Steps is a list of the Step titles for the SOP on 1 – 2 pages. This provides someone a
quick view of all the steps in order and they can go to the detailed steps if more information is
needed about specific step.

10. Complete workflow diagram (Optional)

A workflow diagram is a visual representation of the SOP and can provide a quick overview of
the SOP for individuals.

11. Add additional attachments

Additional attachments may need to be added to any SOP as an Appendix. A common example
could be a copy of a form that needs to be completed as part of the SOP.

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Related Documents

 POL-001 – Policy guidelines for writing policies

 SOP-002 – SOP of writing and releasing Policies

Related Regulations

 None

Related Business Systems

 Policy and Procedure Management system

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 Appendix A - Summary Steps

1. Complete the required identifying information for the SOP.

2. Complete the SOP Coverage information.

3. List the SOP Approvers.

4. Complete Revision History.

5. Document the detailed steps of the SOP.

6. List Related Documents (Optional).

7. List Related Regulations or Standards (Optional).

8. List Related Business Systems or Equipment (Optional).

9. Complete Summary Steps.

10. Complete workflow diagram (Optional).

11. Add additional attachments.

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 Appendix B - Workflow Diagram
Complete
Identifying
Information

Complete SOP
Coverage

List SOP Approvers

Complete Revision
History

Document Detailed
Steps

Related List Related

Documents? Documents

List Related Related

Regulations Regulations?

Related List Related

Systems? Business Systems

Complete Summary
Steps

Complete Workflow Add Additional

Diagram Documents

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 Appendix C – Additional Attachments

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