European Medicines Agency

Work Instructions

Title: Use of TrackWise software for SOP/WIN recording and tracking

Applies to: IQM Coordinators, IQM Manual Coordinators and their delegates

PUBLIC Document no.: WIN/EMEA/0053

Lead Author Approver Effective Date: 22-Oct-08
Name: John S. Forte Name: Melanie Leivers Review Date: 22-Oct-11
Signature: On file Signature: On file
Supersedes: WIN/EMEA/0053 (06-
MAY-08)
Date: 16-Oct-08 Date: 21-Oct-08 TrackWise record no.: 2027

1. Changes since last revision

Addition of new flow chart.
Changes to Steps 30 and 35 and introduction of new steps 31 and 32 to reflect the upgrading of
TrackWise whereby the status of effective SOPs and WIN is labelled as such in the post sign-off stage
and a new status for permanently closed records when replaced by superseding versions has been
created.
Changes to steps 7 and 27 to introduce warning on need to close Word documents when generating
templates from TrackWise.

2. Records
Records generated are saved in TrackWise.

3. Responsibilities
Responsibility for step 1 through to step 34 lies with the IQM Coordinator and for steps 35 and 36
with the IQM Manual Coordinator.

4. Related documents
WIN/EMEA/0035: Creating and maintaining SOP/WIN folders in EDMS.

5. Definitions
IQMCo: IQM Coordinator
PPT: PowerPoint template
SOP: Standard Operating Procedure
UDF: User-defined field
WIN: Work Instructions

Page 1/12
6. Process Map(s)/Flow Chart(s)

SOP Management

IQM Coordinator
Opened Cancel Closed - Cancelled
Mail Merge SOP/WIN
Notify Originator *Summary
Originator will Attach Required
Submit Documentum Locator
for Word & PPT

Drafting Obsolete SOP/WIN Closed - Obsolete

ES
Notify Web Publisher
WIN Consultation not Notify Manual Coordinator
Revision not Needed Send Out to Consultation
Needed
Notify Manual Coordinator
Notify Lead Author

Consultation
Notify Manual Coordinator, Lead Author
if ‘Consultation End Date’ is changed

Trackwise
Perform after X weeks and notify:
IQM Coordinator Mailing List
Consultation Over Manual Coordinator
Lead Author (Assigned to)

If New SOP then X = 4 weeks

Post Drafting Post Review Post Consultation If New urgent SOP then X = 2 weeks
If Revised SOP then X = 2 weeks
If New WIN then based on ‘Consultation End Date’ field
If Revised WIN then based on ‘Consultation End Date’ Date field
Final Draft Checked

Pending Signoff
Mail Merge Transmission Slip

Signoff
ES
Notify Manual Coordinator

Manual Coordinator Additional Business Rules :

Effective (Receipt of
Hardcopy Pending) Auto report on a monthly basis of overdue or due to review
for next 4 months grouped by unit sent to IQM/coordinator
Locked Auto report on a quarterly basis of overdue or due to review
for next 4 months grouped by unit sent to IQM/coordinator &
Hardcopy Received & IQM Coordinator Team Leader
Filed
Notify Lead Author & Mailing List, 26 weeks after
ES ‘Consultation Over’ activity is performed , if ‘External
Consultation’ = ‘Yes’ and record in status ‘Post Consultation’ .
Effective Notify Lead Author & Mailing List, 8 weeks after
‘Consultation Over’ is performed, if ‘External Consultation’ =
‘No’ and record in status ‘Post consultation’ .

IQM Coordinator Set Review date = Effective date + 104 weeks (2 years) for
Close Record records in state ‘Pending Receipt of History’.

Locked

Closed - Done

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 START

1-2: Initiate use of Trackwise

3-4: Create new record

9: Confirm For review 5: SOP/WIN

template type?

New
6-8: Create initial entry and template

10: Submit record

Cancel 11. Status

12. Close record
of record?

Promote

13: Change status to drafting

Obsolete
16: Change 14-15: Outcome
status to obsolete of drafting Consultation
Revision
and close record or review not needed not needed
17: Change status 18: Change status
Consultation needed
to post review to post drafting
19-22: Update record and change
status to consultation

24: Change Yes 23: Change in 26-28: Record quality check and
consultation consultation update status to pending mail
end date end date?
29: Record post sign off quality check
No
25: Record status changes to post
consultation Yes 30: Update record.
Previous version?

31: Close off previous record

No
32: Record close off in 33-34: Promote record to pending
current version receipt of hard copy

35-36: Record receipt of hard copy

and promote record to effective

END

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7. Instructions

Step Action
1 Log on to TrackWise as an IQMCo using your Windows username and password.
The TrackWise Desktop window opens.
2 In current scope, select SOP/WIN (pub).

Creating a new record for a new SOP/WIN or an existing SOP/WIN to be reviewed

3 In the header band, click New to open and create a new record. A new window, Create New
Record, is opened.
4 In the General Information section of the SOP/WIN Information tab, enter the required
data in all fields marked by a red single arrowhead and, if required, in the Drafting/Review
Team field.
Standard Format for Field Entries
Subject: Type full title of SOP/WIN as it should appear in the template header.
Document Number: Type SOP/WIN document no. in standard format SOP/X/NNNN, e.g.
SOP/EMEA/0001, WIN/EMEA/0022, as it should appear in the template header.
Revision Number: Type “0” (zero) for new SOP/WIN or, in the case of SOP/WIN to be
reviewed, the relevant revision number, e.g. “1“ for first revision.
Supersedes: Type “N.A.” for new SOP/WIN or, in the case of SOP/WIN to be reviewed,
the relevant SOP/WIN document number and effective date of the version to be
reviewed, e.g. SOP/EMEA/0001 (01-SEP-05), as it should appear in the template
header.
Owner (Unit): Select the Unit responsible for the SOP/WIN from the drop-down menu.
Sector/Function: Select the Sector/Function responsible for drafting/maintaining the
SOP/WIN from the drop-down menu.
Lead Author: Click on Search to search for and add name.
Approver: Click on Edit to search for name(s) and click OK to add name(s).
Drafting/Review Team: Click on Edit to search for name(s) and click OK to add name(s).
Mailing List: Select IQMCo in Owner (Unit) responsible for the SOP/WIN from drop-down
menu.
5 For a new SOP/WIN, go to Step 6.
For an existing SOP/WIN to be reviewed, go to Step 9.

For a new SOP/WIN

6 Click Save to save and close the record.

A record number is assigned by the system. In the TrackWise Desktop window, the record
Status appears as Opened.

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Step Action
7 Create the template in one of the following ways:
(i) Using mail merge in TrackWise (this will auto-populate pre-defined fields).
It is advisable that you save and close all other Word documents before performing these
steps and checking the template into EDMS.
In the TrackWise Desktop window, select File ÎMail Merge. The Mail Merge
window opens.
In the Selected Form Letter field select SOP Template.doc or WIN Template.doc, as
applicable from the drop-down menu.
Tick the box to include UDFs.
Click on OK.
The SOP/WIN template opens in MS Word. Check the contents of the header and check
in to EDMS (in the appropriate folder – refer to WIN/EMEA/0035).
To close the Mail Merge window click on Exit.
(ii) Using the standard Word template.
Select the SOP template or WIN template saved at X:\Templates\Others\IQM.
Complete the required information in the header and footer fields.
Check the document in to EDMS (in the appropriate folder – refer to WIN/EMEA/0035).
8 In the TrackWise Desktop window, click on the record for the SOP/WIN to open it. In the field
SOP/WIN checked in Documentum, select Yes from the drop-down menu.
Click Save. The Meaning window opens. Select Initial entry from the drop-down menu and
click OK.
Click on Exit to close the record.
Go to Step 10.

For an existing SOP/WIN to be reviewed

9 In the field SOP/WIN checked in Documentum, select Yes from the drop-down menu.
Click Save to save and Exit to close the record.
A record number is assigned by the system. In the TrackWise Desktop window, the record
Status appears as Opened.
10 At this stage the record may be promoted to Drafting stage or Cancelled (e.g. if the record
was created erroneously or development/review of the SOP/WIN is cancelled).
Click on the record in the TrackWise Desktop window. In the Workflow - Post Any
Activity section at the lower right-hand corner of the screen click on Submit.
A new window, Post New Activity, opens.
(Note: The above is not required if the record details window is already open.)
11 To Cancel a new record, go to Step 12.
To promote a new record to Drafting, go to Step 13.

To cancel a new record in status Opened

12 From the field Activity Type, select Cancel from the drop-down menu.
Enter justification for cancellation in field Activity Summary. Click Save to close and
confirm cancellation of record.
In the TrackWise Desktop window, the record Status appears as Closed – Cancelled.
End of procedure.

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Step Action

To promote a new record in status Opened to status Drafting

13 From the field Activity Type, select Submit from the drop down menu.
Click Save to close and confirm new status of record.
In the TrackWise Desktop window, the record Status appears as Drafting.
An automated notification generated by TrackWise is sent by e-mail to the IQMCo who
created the record (the “Originator”). Attach (to the e-mail) locators to the SOP/WIN
template and, if applicable, the process map template in the EDMS folder for that SOP/WIN.
Select the required fields in the e-mail message and forward to the Lead Author.
You may now choose to log out of TrackWise from File ÎLog out or continue to work in
the system.
14 At this stage there is a break in the procedure as the Lead Author and drafting team
develop/review the SOP/WIN. At the end of this stage there are four available options.
1. Following review of an existing SOP/WIN, the document is considered obsolete.
2. Following review of an existing SOP/WIN, the document does not require any revision.
3. Following drafting of a new WIN or review of an existing WIN there is no need for
consultation.
4. Following drafting of a new SOP/WIN or review of an existing SOP/WIN there is a need
for consultation.
15 Log on to and open the TrackWise Desktop window as described in Steps 1 and 2.
Highlight the record for the required SOP/WIN by clicking on the { symbol (‘radio button’)
next to the record number in the TrackWise Desktop window.
The Workflow - Post Any Activity section at the lower right-hand corner of the screen
shows the Instant Action Activities: Obsolete SOP/WIN, Send Out to Consultation,
Revision not Needed, WIN Consultation not Needed.
If, following review of an existing SOP/WIN, the document is considered obsolete, go to
Step 16.
If, following review of an existing SOP/WIN, the document does not require any revision,
go to Step 17.
If following drafting of a new WIN or review of an existing WIN there is no need for
consultation, go to Step 18.
If following drafting of a new SOP/WIN or revision of an existing SOP/WIN there is a need
for consultation, go to Step 19.

For an obsolete SOP/WIN

16 In the Workflow - Post Any Activity section at the lower right-hand corner of the screen click on
Obsolete SOP/WIN.
A new window, Post New Activity, opens. Obsolete SOP/WIN should be visible in the
field Activity Type.
Enter justification for obsolete SOP/WIN in field Activity Summary. Click Save.
A new window, Electronic Signature, opens. Enter your Windows password and click OK.
The Electronic Signature screen closes. In the TrackWise Desktop window the status of record
is now Closed – Obsolete.
Automated notifications generated by TrackWise are sent by e-mail to the Web Publishers and the

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Step Action
IQM Manual Co-ordinators with instructions to remove obsolete SOP/WIN from the external web
site and intranet, respectively.
End of procedure.

For a reviewed SOP/WIN not requiring revision

17 In the Workflow - Post Any Activity section at the lower right-hand corner of the screen click on
Revision not Needed.
A new window, Post New Activity, opens. Revision not Needed should be visible in the
field Activity Type.
In the TrackWise Desktop window the status of record is now Post Review.
Go to Step 26.

For a new/reviewed WIN not requiring consultation

18 In the Workflow - Post Any Activity section at the lower right-hand corner of the screen click on
WIN Consultation not Needed.
A new window, Post New Activity, opens. WIN Consultation not Needed should be
visible in the field Activity Type. Click Save.
In the TrackWise Desktop window the status of record is now Post Drafting.
Go to Step 26.

For a new/revised SOP/WIN requiring consultation

19 Click on the record number in the TrackWise Desktop window to open Record Details
window.
In the Post Any Activity section, select Send Out to Consultation from the drop-down
menu.
The red single arrowheads in the General Information section change to double arrowheads
while new red single arrowheads appear in the Consultation Information section.
20 Click on the second tab Checklist. When conducting the quality check on the draft
SOP/WIN, complete all mandatory fields for Questions 1.1 to 1.9 in the section Check of
Initial Draft SOP/WIN (before consultation) by selecting from the options in the drop-
down menus. Refer to Annex 1 for list of questions.
(N.B. All questions must be selected otherwise an error message will be generated when
attempting to save changes.)
21 Click on SOP/WIN Information tab and go to Consultation Information section. Enter
required data in all fields marked by a red single arrowhead.
Standard Format for Field Entries
Document Type: Select from drop-down menu.
External Consultation: Select from drop-down menu.
Consultation End Date: If the applicable standard time frame described in the on-screen
explanatory note is to be followed, leave this field blank. Otherwise select the required date
by clicking on the icon . (N.B. The recorded consultation end date applies only to
internal EMEA consultation. In case of parallel external consultation, the post consultation
status of the SOP/WIN is followed up by means of automated notifications generated by
TrackWise - see step 25.)
Draft for Consultation: Click on file to open the Draft for Consultation window and click

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Step Action
on the Browse tab. When prompted log on to EDMS using you Windows password and go
the relevant SOP/WIN file to view the contents. To select required files (i.e. SOP/WIN and
any forms/templates created in parallel) click on Select next to the file name. (N.B. Do not
click on the file name otherwise it will be checked out of EDMS. Click on Unselect to reverse
file selection.) Click on Main tab to view selected files. Click OK to close window.
22 Click on Save. The Meaning window opens. Do not modify any entries in the fields. Click
OK. Meaning window closes.
Click Exit to close the Record Details window. In the TrackWise Desktop window the
status of record is now Consultation.
Automated notifications generated by TrackWise are sent by e-mail to the Manual
Coordinator and the Lead Author.
You may now choose to log out of TrackWise from File ÎLog out or continue to work in
the system.
23 At this stage there is a break in the procedure for the duration of the consultation period. If
during consultation a change needs to be made to the consultation end date (e.g. an error was
made when the initial time frame was selected, an extension is requested), go to Step 24.
If no change is made to the consultation end date, go to Step 25.

Amending the End of Consultation date (after promotion of record to state ‘Consultation’)

24 Log on to and open the TrackWise Desktop window as described in Steps 1 and 2.
Open the Record Details window for the required SOP/WIN by clicking on the record
number in the TrackWise Desktop window.
In the Consultation Information section, select the required date by clicking on the icon
next to the Consultation End Date field.
Click on Save.
The Meaning window opens. In the Consultation End Date field, select the appropriate
reason for the date change from the drop-down menu. Click OK. Meaning window closes.
Click Exit to close the Record Details window. In the TrackWise Desktop window the
End of Consultation date has been updated.
Automated notifications generated by TrackWise are sent by e-mail to the Manual
Coordinator and the Lead Author.
You may now choose to log out of TrackWise from File ÎLog out or continue to work in
the system.
25 At the end of the consultation period, TrackWise automatically promotes the record through
the activity Consultation Over and sends out automated notifications by e-mail to the Lead
Author, responsible IQM Coordinator and Manual Coordinator.
In the TrackWise Desktop window the status of record is now Post Consultation.
If the SOP/WIN has been marked for External Consultation in TrackWise and the record
remains in the Post Consultation status for 26 weeks after Consultation Over, an automated
reminder notification is sent by e-mail to the Lead Author and the responsible IQMCo.
If the SOP/WIN has not been marked for External Consultation in TrackWise and the record
remains in the Post Consultation status for 8 weeks after Consultation Over, an automated
reminder notification is sent by e-mail to the Lead Author and the responsible IQMCo.

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Step Action

Quality check on final draft SOP/WIN before sign-off

26 If required, log on to and open the TrackWise Desktop window as described in Steps 1 and
2.
Click on the record number in the TrackWise Desktop window to open Record Details
window.
In the Post Any Activity section, select Final Draft Checked from the drop-down menu.
Click on the second tab Checklist. When conducting the quality check on the final draft
SOP/WIN before sign-off, complete all mandatory fields for Questions 2.1 to 2.9 in the
section Check of Final Draft SOP/WIN (before sign-off) by selecting from the options in
the drop-down menus. Refer to Annex 1 for list of questions.
(N.B. All questions must be selected otherwise an error message will be generated when
attempting to save changes.)
Click on Save. The Meaning window opens. Do not modify any entries in the fields. Click
OK. Meaning window closes.
Click Exit to close the Record Details window. In the TrackWise Desktop window the
status of record is now Pending Signoff.
27 Create the transmission slip in one of the following ways:
(i) Using mail merge in TrackWise (this will auto-populate pre-defined fields).
It is advisable that you save and close all other Word documents before performing these
steps and checking the template into EDMS.
In the TrackWise Desktop window, select File ÎMail Merge. The Mail Merge window
opens.
In the Selected Form Letter field select TRANSMISSION SLIP.doc from the drop-down
menu.
Tick the box to include UDFs.
Click on OK.
The Transmission Slip opens in MS Word. Complete the required details
To close the Mail Merge window click on Exit.
(ii) Using the standard Word template.
Select the SOP/WIN transmission slip template saved at X:\Templates\Others\IQM.
Complete the required details.
Check the document in to EDMS (in the appropriate folder – refer to WIN/EMEA/0035).
28 At this stage there is a break in the procedure for the Lead Author and Approver to sign the
SOP/WIN.

Quality check on hard and electronic copies of SOP/WIN after sign-off

29 If required, log on to and open the TrackWise Desktop window as described in Steps 1 and
2.
Click on the record number in the TrackWise Desktop window to open Record Details
window.
In the Post Any Activity section, select Signoff from the drop-down menu and click on
Now.
Click on the second tab Checklist. When conducting the quality check on the hard and
electronic copies of the signed-off SOP/WIN, complete all mandatory fields for Questions
3.1 to 3.9 in the section Check of Signed-off SOP/WIN (before publication) by selecting
from the options in the drop-down menus. Refer to Annex 1 for list of questions.
(N.B. All questions must be selected otherwise an error message will be generated when

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Step Action
attempting to save changes.)
30 Click on SOP/WIN Information tab and go to Post Signoff Information section. Enter
required data in all fields.
Standard Format for Field Entries

Effective Date: Select the required date by clicking on the icon .

Public / Confidential: Select from drop-down menu.
PDF in Signoff Folder: Confirm that PDF version of SOP/WIN has been saved in signoff
folder by selecting Yes from drop-down menu.
Final Document: Click on file to open the Final Document window and click on the
Browse tab. When prompted log on to EDMS using you Windows password and go the
relevant SOP/WIN file to view the contents. To select required SOP/WIN click on Select
next to the file name. (N.B. Do not click on the file name otherwise it will be checked out of
EDMS. Click on Unselect to reverse file selection.) Click on Main tab to view selected files.
Previous version closed?: If the TrackWise record is for a new SOP/WIN that is not
superseding a previous version or another SOP/WIN, select No previous version from drop-
down menu, click OK to close window and proceed to step 33. If the TrackWise record is
for a SOP/WIN that is superseding a previous version or another SOP/WIN for which a
record exists in TrackWise, go to step 31.
31 Permanent closure of Effective Records
Highlight the record for the required SOP/WIN (to be superseded or replaced) by clicking on
the { symbol (‘radio button’) next to the record number in the TrackWise Desktop
window.
Under the Instant Action Activities heading at the bottom right-hand corner of the window,
click on Close SOP/WIN.
The Electronic Signature window opens. (N.B. Once past the electronic signature stage,
the IQM Coordinator has closed permanently an effective record.) Do not modify any
entries in the fields. Enter your Windows password. Click OK. Electronic Signature
window closes.
In the TrackWise Desktop window the status of record is now Closed (the padlock ±
symbol indicates that the record is locked and cannot be modified but is available as read-
only).
32 Return to the Post Signoff Information section of the TrackWise record you were working
on in step 30 to finalise data entry in the fields.
Standard Format for Field Entries
Previous version closed?: Select Yes from the drop-down menu.
33 Click on Save. The Electronic Signature window opens. (N.B. Once past the electronic
signature stage, the IQMCO cannot make any changes to the record.) Do not modify any
entries in the fields. Enter your Windows password. Click OK. Electronic Signature
window closes.
Click Exit to close the Record Details window. In the TrackWise Desktop window the
status of record is now Pending Receipt of Hardcopy (the padlock ± symbol indicates that
the record is locked and cannot be modified but is available as read-only).
You may now choose to log out of TrackWise from File ÎLog out or continue to work in
the system.
34 At this stage there is a break in the procedure as the SOP/WIN goes through the EMEA Web
Publishers to the Manual Coordinator.

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Step Action

Confirmation of Receipt and Filing of Hardcopy

35 Log on to TrackWise Desktop as IQM Manual Co-ordinator using your Windows username
and password.
The TrackWise Desktop window opens.
Open the Record Details window for the required SOP/WIN by clicking on the record
number in the TrackWise Desktop window.
In the Post Any Activity section, select Hardcopy Received and Filed from the drop-down
menu and click on Now.
Click Save. The Electronic Signature window opens. (N.B. Once past the electronic
signature stage, the IQM Manual Coordinator cannot make any changes to the record.) Do
not modify any entries in the fields. Enter your Windows password. Click OK. Electronic
Signature window closes.
Click Exit to close the Record Details window. In the TrackWise Desktop window the
status of record is now Effective (the padlock ± symbol indicates that the record is locked
and cannot be modified but is available as read-only).
36 You may now choose to log out of TrackWise from File ÎLog out or continue to work in the
system.

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Annex 1: SOP/WIN Checklists in TrackWise Record Details window

Question

Check of Initial Draft SOP/WIN (before consultation)

1.1 SOP/WIN - Status in header reads: CONSULTATION (CONFIDENTIAL)
1.2 SOP - Required fields in header are complete (Title, Status, Lead Author name, Approver
name, Document Number, Supersedes, Trackwise record number)
1.3 WIN - Required fields in header are complete (Title, Applies to, Status, Lead Author
name, Approver name, Document Number, Supersedes, Trackwise record number)
1.4 SOP/WIN - Status in footer reads: CONSULTATION (CONFIDENTIAL)
1.5 SOP/WIN - Document Number in footer same as in header
1.6 SOP - All required sections have been completed
1.7 WIN - All pre-defined sections have been completed
1.8 SOP/WIN - Process map has been pasted as an image in the required section
1.9 SOP/WIN - Steps described in Procedure match steps depicted in process map
Check of Final Draft SOP/WIN (before sign-off)
2.1 SOP/WIN - Status in header reads: PUBLIC or CONFIDENTIAL
2.2 SOP - Required fields in header are complete (Title, Status, Lead Author name, Approver
name, Document Number, Supersedes, Trackwise record number)
2.3 WIN - Required fields in header are complete (Title, Applies to, Status, Lead Author
name, Approver name, Document Number, Supersedes, Trackwise record number)
2.4 SOP/WIN - Designated fields in header for sign-off & post-sign-off are blank (Lead
Author signature & date, Approver signature & date, Effective Date, Review Date)
2.5 SOP/WIN - Status in footer reads: PUBLIC or CONFIDENTIAL as in header
2.6 SOP/WIN - Document Number in footer same as in header
2.7 SOP - All required sections have been completed correctly
2.8 WIN - All pre-defined sections have been completed correctly
2.9 SOP/WIN - Process map has been pasted as an image in the required section
Check of Signed-off SOP/WIN (before publication)
3.1 SOP/WIN - HARD COPY - Required Lead Author & Approver signatures and dates are
complete
3.2 SOP/WIN - HARD COPY - Required fields in header (Effective Date, Review Date)
updated in ink in format DD-MMM-YY
3.3 SOP/WIN - HARD COPY - Footer updated in ink with Effective Date in format DD-
MMM-YY, on each page except the first, next to Document Number
3.4 SOP/WIN - WORD FILE - Header updated with Lead Author & Approver signatures 'On
file' and original signature dates as in hard copy in format DD-MMM-YY
3.5 SOP/WIN - WORD FILE - Footer updated with Effective Date in format DD-MMM-YY,
on each page except the first, next to Document Number
3.6 SOP/WIN - PDF FILE - PDF rendition of WORD file checked in Documentum (as next
version after final WORD document) with 'Ver DD-MMM-YY' completed in
Documentum label field
3.7 SOP/WIN - PDF FILE FOR EXTERNAL PUBLICATION - Copy sent to G:\External
Information Draft\SIGN OFF\IQM
3.8 SOP/WIN - PROCESS MAP POWERPOINT FILE - Documentum label field updated
with 'Ver DD-MMM-YY'
3.9 SOP/WIN - Hard copy and transmission slip forwarded to web publishers

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