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Title: Publication of, and training on standard operating procedures and work instructions
Status: PUBLIC
Lead author
Approver
Signature: On file
Signature: On file
Supersedes:
Date: 10-Jul-13
Date: 10-Jul-13
SOP/EMA/0037 (31-AUG-11)
TrackWise record no.: 3949
1. Purpose
To describe the procedure for publishing new and reviewed standard operating procedures and work
instructions, withdrawing obsolete SOPs and WIN, and maintaining courses in SAP HR IMS.
2. Scope
This SOP applies to:
3. Responsibilities
Each Head of Unit under the responsibility of the Executive Director must ensure that this procedure is
adhered to within their own unit. The responsibility for the execution of a particular part of this
procedure is identified in the right-hand column of section 9.
Revision of step 4 to adapt instructions on adding title to file summary in MS Word 2010.
European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged.
Addition of new steps 16 to 19, 28, and 32 to 39 to describe how to maintain courses in SAP HR
IMS and update Units SOP/WIN training matrices.
6. Related documents
SAP-HR-II IMS - User Manual for the back-end (located on the intranet at
http://emeaplus/EMEAPlus_WebsiteNew/IQM/html/Manuals.htm)
7. Definitions
A-HR-PER: Personnel Section
DREAM: Document records electronic archive management system
IQMCo: Unit IQM co-ordinator or delegate
ManualCo: IQM manual co-ordinator or delegate
SAP HR IMS: IMS learning solution module in the Human Resources component of SAP system
SOP: Standard operating procedure
TrackWise: Software for the tracking of processes and the creation and archiving of related records
and associated documents. The SOP/WIN Management module is intended for the recording and
tracking of SOPs and WIN
WIN: Work instructions
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Obsolete
1. Is
SOP/WIN
for publication or
obsolete?
For publication
2. Record quality check
7. Status of
SOP/WIN?
Confidential SOP/WIN
24. Is
SOP/WIN published on
external
web site?
Yes
25. Remove SOP/WIN from
external web site
26. Remove SOP/WIN from
IMS manual
27. Delimit the training
course in SAP
28. File hard copy as
obsolete
16. Is SOP/WIN
new or revised?
Revised
17. Delimit training course
for superseded version in
SAP
New
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From
step
29.
30. Announce on intranet
news page
No
End
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9. Procedure
Step
Action
Responsibility
IQMCo
IQMCo
and carry out and record the quality check (Check of Signed-off
SOP/WIN (before publication)) while performing steps 3 and 4
below.
3
IQMCo
Date and Review Date using the format DD-MMM-YY, e.g. 08-JUN07.
The Effective Date should not be earlier than the date of signature
by the approver.
The Review Date should be the Effective Date plus the validity
period prescribed by the EMA, e.g. 3 years from the Effective Date.
Update footer of signed hard copy in ink with the same Effective
Date using the format DD-MMM-YY on each page (except the first)
next to the document number.
4
IQMCo
file in the signature cells and with the original dates of signature
by the lead author and approver and the Effective Date and Review
Date using the format DD-MMM-YY.
Update in typing the footer with the final status and with the
Effective Date using the format DD-MMM-YY. The final footer
should have these details:
Standard operating procedure - <STATUS>
<SOP/a/bbbb>, <DD-MMM-YY>
Page x/y
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Step
Action
Responsibility
IQMCo
IQMCo
IQMCo
IQMCo
Remember to close off the record for the superseded version (refer
to WIN/EMA/0053).
9
IQMCo
Manual Co.
Go to step 14.
Public SOP/WIN for external publication
10
IQMCo
IQMCo
Remember to close off the record for the superseded version (refer
to WIN/EMA/0053).
Forward hard copy of SOP/WIN and transmission slip to Web
Publishers.
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Step
Action
Responsibility
12
Web Publishers
Web Publishers
14
ManualCo
Publish title and PDF of SOP/WIN (saved in TrackWise) in intranetbased IMS Manual.
15
ManualCo
Manual Co
ManualCo
ManualCo
the SOP/WIN (refer to SAP-HR-II IMS - User Manual for the backend).
Obsolete SOP/WIN
19
IQMCo
IQMCo
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Step
Action
Responsibility
IQMCo
IQMCo
IQMCo
WIN/EMA/0053).
24
IQMCo
Web publishers
26
ManualCo
In SAP HR IMS module, delimit the training course for the obsolete
ManualCo
ManualCo
Inform
by
Intranet
News
Editors
to
advertise
ManualCo
Intranet
page.
News Editors
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Step
Action
Responsibility
31
ManualCo
from A-HR-PER.
Note: Updates include new staff, staff that left the Agency and
internal staff movements.
32
ManualCo
34.
If there are no changes, procedure ends.
Day X-7: Updating and transmission of matrices
33
Update each Unit matrix to reflect the following changes since the
ManualCo
previous update.
New SOP/WIN: insert new column in matrix using pink for the
background.
New Staff: insert new row in matrix using pink for the
background.
34
ManualCo
IQMCo
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Step
Action
Responsibility
36
IQMCo
For
staff
movement
within
same
unit,
if
IQMCo
ManualCo
10. Records
When completed and approved the original, signed hard copy of a SOP or WIN is retained by the IQM
Manual Co-ordinator in the controlled documents master file.
Electronic records of SOPs are generated and saved in TrackWise.
Electronic documents are filed, in DREAM under: Cabinets/06. Corporate governance/06.2 Integrated
Management System/2. IMS Manual/5. SOPs and WINs.
Electronic IQM training courses are created in SAP HR IMS.
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1.2
In the Printed Watermark window, select Text watermark and type Obsolete (DD-MMM-YY) in
the Text field, select Verdana font and black as the colour and untick Semitransparent. Click on OK for
watermark to be inserted in each page of the document.
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With MS PowerPoint document in edit view, select Inser>WordArt and select style as indicated
below.
1.4
In the text box, type Obsolete (DD-MMM-YY). If the document consists of more than one
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With MS Visio document in edit view, select Insert > Text Box > Horizontal.
1.6
Drag icon over page and draw text box. Type Obsolete (DD-MMM-YY) and change font to
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