Track Wise

European Medicines Agency Work Instructions

/12

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

PUBLIC /12 WIN/EMEA/0053, 22-Oct-08

6. Process Map(s)/Flow Chart(s)

IQM Coordinator

SOP Management

Opened Cancel Closed - Cancelled

Submit

Drafting

Send Out to Consultation

*Summary Required

Notify Originator Originator will Attach Documentum Locator for Word & PPT

Consultation

Notify Lead AuthorNotify Manual Coordinator

Lead Author (Assigned to)Manual CoordinatorIQM Coordinator Mailing List

If New SOP then X = 4 weeksIf New urgent SOP then X = 2 weeksIf Revised SOP then X = 2 weeksIf New WIN then based on ‘Consultation End Date’ fieldIf Revised WIN then based on ‘Consultation End Date’ Date field

Post Consultation

Final Draft Checked

Consultation Over

Trackwise

Pending SignoffMail Merge Transmission Slip

Mail Merge SOP/WIN

SignoffES

Closed - Done

Notify Manual Coordinator

Obsolete SOP/WIN Closed - Obsolete

ES

Notify Manual CoordinatorNotify Web Publisher

Revision not Needed

Post Review

WIN Consultation not Needed

Post Drafting

Effective (Receipt of Hardcopy Pending)

Hardcopy Received & Filed

Manual Coordinator

ES

Locked

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

Perform after X weeks and notify:

Additional Business Rules :

Auto report on a monthly basis of overdue or due to review for next 4 months grouped by unit sent to IQM/coordinator

Auto report on a quarterly basis of overdue or due to review for next 4 months grouped by unit sent to IQM/coordinator & IQM Coordinator Team Leader

Notify Lead Author & Mailing List, 26 weeks after ‘Consultation Over’ activity is performed , if ‘External Consultation’ = ‘Yes’ and record in status ‘Post Consultation’ .

Notify Lead Author & Mailing List, 8 weeks after ‘Consultation Over’ is performed, if ‘External Consultation’ = ‘No’ and record in status ‘Post consultation’ .

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

Effective

Locked

Close Record

IQM Coordinator


START

1-2: Initiate use of Trackwise

3-4: Create new record

5: SOP/WINtype?

9: Confirm template

6-8: Create initial entry and template

10: Submit record

11. Status of record?12. Close record

13: Change status to drafting

14-15: Outcomeof draftingor review

19-22: Update record and change status to consultation

23: Change in consultation

end date?

24: Changeconsultation

end date

25: Record status changes to post consultation

29: Record post sign off quality check

30: Update record.Previous version?

31: Close off previous record

32: Record close off in current version

33-34: Promote record to pending receipt of hard copy

35-36: Record receipt of hard copy and promote record to effective

END

For review

New

Cancel

Promote

Obsolete

Consultation needed

Revision not needed

Yes

Consultation not needed

Yes

No

No

16: Change status to obsolete and close record

17: Change status to post review

18: Change status to post drafting

26-28: Record quality check and update status to pending mail


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.


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 Mail 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.


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 Log 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


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.


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


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.


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.


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.


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 Mail 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


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.


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.


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).


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.


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 Log out or continue to work in the system.


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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