standard operating procedure for document version control - Accord

ACCORD/ECTU
SOP Number: ACCORD/ECTU/SOP39/1.0
NHS Lothian R&D and Version: 1.0
The University of Edinburgh Effective Date: 01/10/2008
STANDARD OPERATING PROCEDURE FOR DOCUMENT
VERSION CONTROL
SOP NUMBER:
ACCORD/ECTU/SOP39/1.0
VERSION NUMBER: 1.0
PREVIOUS VERSIONS: N/A
EFFECTIVE DATE: 01/10/2008
REVIEW DATE: 30/09/2010
AUTHOR:
Alex MacLellan (QA Manager)
APPROVED BY (1):
.....Tina.McLelland...................................
(R&D Governance Manager, NHS Lothian)
DATE APPROVED: 29/09/2008
APPROVED BY (2):
..... Anne.Langston................................
(Associate Director, ECTU, University of Edinburgh)
DATE APPROVED: 25/09/2008
RELEASED BY:
.....Alex.MacLellan........................................
(QA Manager, ECMC, University of Edinburgh)
DATE RELEASED: 25/09/2008
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ACCORD/ECTU
SOP Number: ACCORD/ECTU/SOP39/1.0
NHS Lothian R&D and Version: 1.0
The University of Edinburgh Effective Date: 01/10/2008
DOCUMENT HISTORY
Version Edited by (job title): Effective Details of editions made:
Number:
Date:
1.0 01/10/2008 Original
1. PURPOSE
Version control is the management of multiple revisions to the same document.
Version control enables us to tell one version of a document from another.
Version control is important for documents that undergo a lot of revision and
redrafting and is particularly important for electronic documents because they can
easily be changed by a number of different users, and those changes may not be
immediately apparent. Knowing which version of a document you are looking at is
important if you are trying to find out which version of a document is currently in
force, or which version was in use at a particular time. Version control is also
important if one is working on a collaborative document with a number of contributors
and/or frequent revisions.
2. APPLICABILITY
This SOP applies to all staff who create and edit documents with multiple versions.
3. POLICY
Any staff member can perform the activities described in this procedure.
4. PROCEDURE
4.1 Version Numbers
4.1.1 Use a unique version number to distinguish one version from another.
Use this procedure for all documents where more than one version exists, or
is likely to exist in the future.
4.1.2 The numbering system which should be used, uses consecutive whole
numbers, i.e. version 1 for the first, version 2 for the second and so on. A
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ACCORD/ECTU
SOP Number: ACCORD/ECTU/SOP39/1.0
NHS Lothian R&D and Version: 1.0
The University of Edinburgh Effective Date: 01/10/2008
minor or major change will result in the use of the next consecutive whole
number.
4.1.3 There can be any number of draft copies of each version. If a new
document has three draft copies they should be labelled ‘version 1 draft 1’,
version 1 draft 2’ & ‘version 1 draft 3’ not ‘version 1’, ‘version 2’ and ‘version
3’.
4.1.4 Put the version number on the document itself. The placement of the
version number will depend on the style of the document, but the most
common places for version numbers are the document cover, or in either the
header or footer text of each page.
4.2 Naming Conventions
4.2.1 For SOPs, include the version number at the end of the document
number, as described in section 5.3 of the SOP ECMC/ADM/001.
4.2.2 For all other documents include the version number at the end of the
document’s file name e.g. ‘SOP Review Checklist version 1’.
4.2.3 Always add the date, to the header and/or footer, when any changes
were made to the document.
4.2.4 The words ‘Draft’ or ‘Final’ can be added to the end of the file name to
indicate the status of the version.
4.2.5 Use this procedure for all documents where more than one version
exists, or is likely to exist in the future.
4.3 Read-only Option
4.3.1 To reduce the likelihood of one version being overwritten with another
use the read-only tag. Applying a read-only tag will prompt
users to save the document with a new version number if they make any
changes to the original document.
4.3.2 Use this procedure for finalised documents where loss of the original
would be a problem e.g. participant clinical study documentation.
4.3.3 To add a read-only tag to your document:
• On your computer screen, navigate to your document.
• Right click on the document name and select ‘Properties’.
• On the ‘General’ tab check the ‘Read-only’ box.
• Select ‘Apply’ and then ‘OK’.
4.4 PDF Option
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ACCORD/ECTU
SOP Number: ACCORD/ECTU/SOP39/1.0
NHS Lothian R&D and Version: 1.0
The University of Edinburgh Effective Date: 01/10/2008
If one is not keeping an editable version, a PDF (Portable Document Format)
copy of the document can be created. Depending to which computer system
one is linked, the creation of these files will involve different methods.
Conferring with one’s local IT Administrator is suggested if creation of this
type of file is required.
4.5 Document Tracking
5.5.1 For regulatory requirements, it is necessary to keep track of document
changes to show when and which changes were made. This can be done by
a version control/history table or a saved ‘track changes’ file.
4.5.2 The table should be updated each time a change is made to the
document, with the answers to the following questions:
• What is the new version number?
• What was the change?
• Who made the change?
• When was the change made?
4.5.3 The table can either be included at the start of the document, e.g. in
SOPs, or it can be created as a separate document and filed in the same
folder as the document concerned.
4.5.4 A ‘track changes’ file can be created for every new version by using the
‘Track Changes’ option found on the Microsoft ‘Tools’ menu bar. This shows
all changes that have been made to the previous version. This document
should be saved and filed in the same folder as the document concerned.
4.5.5 Remember to remove track change information from the final version of
the document.
5. ATTACHMENTS
N/A.
6. RELEVANT DOCUMENTS
N/A.
7. DEFINITIONS
N/A.
8. REFERENCES
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ACCORD/ECTU
SOP Number: ACCORD/ECTU/SOP39/1.0
NHS Lothian R&D and Version: 1.0
The University of Edinburgh Effective Date: 01/10/2008
The Medicines for Human Use (Clinical Trials) Regulations 2004, (SI 2004 No. 1031).
The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006, (SI
2006 No. 1928).
Good Clinical Laboratory Practice (GCLP), BARQA 2003.
Declaration of Helsinki, Clarification of 5 th Revision, 2004.
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