EMEA RUP CHANGE CONTROL PROCESS VERSION 1esubmission.ema.europa.eu/doc/EMEA_Change_Control_Process.pdf · European Medicines Agency Communications and Networking Doc ID: EMEA/342717/2006

European Medicines Agency Communications and Networking Doc ID:

EMEA/342717/2006

EMEA RUP Change Control Process - 1/39

EMEA RUP CHANGE CONTROL PROCESS VERSION 1.0


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TABLE OF CONTENTS TABLE OF CONTENTS ................................................................................................................................................. 2

1 ABOUT THIS DOCUMENT................................................................................................................................... 4

2 SCOPE....................................................................................................................................................................... 7

3 BUSINESS ACTORS ............................................................................................................................................... 8

4 PROCESS MAP...................................................................................................................................................... 10 4.1. SEND PROCESS .................................................................................................................................................. 12

4.1.1 Obtain the Form ....................................................................................................................................... 12 4.1.2 Fill in the Form......................................................................................................................................... 12 4.1.3 Send the Form........................................................................................................................................... 13

4.2. RECEIVE PROCESS ............................................................................................................................................. 15 4.2.1 Receive CR................................................................................................................................................ 15 4.2.2 Acknowledge CR....................................................................................................................................... 15 4.2.3 NCA/EMEA CR......................................................................................................................................... 16 4.2.4 Evaluate Confidentiality ........................................................................................................................... 16 4.2.5 Remove confidentiality information.......................................................................................................... 16 4.2.6 Other than NCA/EMEA CR ...................................................................................................................... 16 4.2.7 Send Acknowledgment .............................................................................................................................. 16 4.2.8 Receive CR................................................................................................................................................ 16 4.2.9 Distribute CR ............................................................................................................................................ 16 4.2.10 Receive Acknowledgement........................................................................................................................ 16 4.2.11 Send Delivery Report ................................................................................................................................ 16 4.2.12 Store Delivery Receipt .............................................................................................................................. 16 4.2.13 Add Entry in CR and in Q&A Tracking Table.......................................................................................... 17 4.2.14 Publish Table ............................................................................................................................................ 17 4.2.15 Announce Publication............................................................................................................................... 18 4.2.16 Receive Announcement ............................................................................................................................. 18

4.3. EVALUATE THE CHANGE REQUEST.................................................................................................................... 20 4.3.1 Evaluation Meeting................................................................................................................................... 21 4.3.2 Review CRs ............................................................................................................................................... 21 4.3.3 Not Accepted............................................................................................................................................. 21 4.3.4 In Scope .................................................................................................................................................... 21 4.3.5 Reject CR .................................................................................................................................................. 22 4.3.6 Send Notification ...................................................................................................................................... 22 4.3.7 Accept CR ................................................................................................................................................. 22 4.3.8 Update Tracking Table ............................................................................................................................. 22 4.3.9 Issue Impact Analysis Document .............................................................................................................. 23 4.3.10 Publish tracking Table.............................................................................................................................. 23

4.4. IMPLEMENTATION OF THE CHANGE REQUEST.................................................................................................... 24 4.4.1 CR Accepted.............................................................................................................................................. 25 4.4.2 CR Meeting ............................................................................................................................................... 25 4.4.3 CR Review................................................................................................................................................. 25 4.4.4 CR Not Clear ............................................................................................................................................ 25 4.4.5 Request CR Clarifications ........................................................................................................................ 25 4.4.6 CR Clear ................................................................................................................................................... 25 4.4.7 CR Not Feasible........................................................................................................................................ 25 4.4.8 Provide CR Rejection Report.................................................................................................................... 26 4.4.9 Update Tracking Table Request ............................................................................................................... 26 4.4.10 CR Feasible .............................................................................................................................................. 26 4.4.11 Provide a Technical Proposal .................................................................................................................. 26 4.4.12 1st Review Request .................................................................................................................................... 26


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4.4.13 Incorporate Comments (1st Review).......................................................................................................... 26 4.4.14 CR Urgent................................................................................................................................................. 26 4.4.15 CR Not Urgent .......................................................................................................................................... 27 4.4.16 2nd Review Request.................................................................................................................................... 27 4.4.17 Incorporate Comments (2nd Review)......................................................................................................... 27 4.4.18 Sign-off Proposal ...................................................................................................................................... 27 4.4.19 Sign-off...................................................................................................................................................... 27 4.4.20 Sign-off Comments.................................................................................................................................... 27 4.4.21 Incorporation of Final Comments ............................................................................................................ 27 4.4.22 Technical Proposal – Final ...................................................................................................................... 27 4.4.23 Draft Release ............................................................................................................................................ 27

4.5. PUBLISH ............................................................................................................................................................ 29 4.5.1 CR not Urgent........................................................................................................................................... 30 4.5.2 Publish Draft Release ............................................................................................................................... 30 4.5.3 Public Review ........................................................................................................................................... 30 4.5.4 Public Comments ...................................................................................................................................... 30 4.5.5 Incorporate Comments ............................................................................................................................. 30 4.5.6 Review Comments & Sign-off ................................................................................................................... 30 4.5.7 Sign-off Comments.................................................................................................................................... 30 4.5.8 Incorporate Comments ............................................................................................................................. 30 4.5.9 Send Publication Proposal ....................................................................................................................... 30 4.5.10 Build Production Release ......................................................................................................................... 30 4.5.11 CR Urgent................................................................................................................................................. 30 4.5.12 No Public Comments ................................................................................................................................ 31 4.5.13 No Sign-off comments ............................................................................................................................... 31 4.5.14 Production Release................................................................................................................................... 31

DOCUMENT INFORMATION.................................................................................................................................... 38 OPEN ISSUES.................................................................................................................................................................. 38 DOCUMENT LOCATION .................................................................................................................................................. 38 DOCUMENT ID............................................................................................................................................................... 38 REFERENCED DOCUMENTS ............................................................................................................................................ 38 DOCUMENT HISTORY .................................................................................................................................................... 38 DOCUMENT DISTRIBUTION ............................................................................................................................................ 38

APPENDIX A: EU TELEMATICS Q&A OR CHANGE REQUEST ...................................................................... 32

APPENDIX B: EU TELEMATICS CR AND Q&A TRACKING TABLE .............................................................. 33

PROJECT PARTICULARS.......................................................................................................................................... 36


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ABOUT THIS DOCUMENT This document describes the adopted generic workflow for a Change Control Process (CCP) and, in Appendix A the detailed implementation for eSubmission - Product Information Management (PIM).. By use of PIM as an example project, this document shows how the steps for the sending, receipt, evaluation, implementation and publication of a Change Request (CR) or Question and Answer (Q&A) can be used and specifically tailored for IT Systems hosted by EMEA and specifications, standards, guidance and business processes related to those systems.


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EXECUTIVE SUMMARY This Change Control Process (CCP) has been adopted by the Communication and Networking Unit of the European Medicines Agency (EMEA) Standards Committee on 27 February 2008 for use by the Unit. The process details the sending, receipt, evaluation, implementation and publication processes of a Change Request (CR) or Question and Answer (Q&A) for IT Systems hosted by EMEA and specifications, standards, guidance and business processes related to those systems. This CCP applies to any change of any system, specifications or standards defined by EMEA, the Telematics Implementation Groups, regulatory guidance or business process for projects implemented by EMEA and using RUP methodology. It also covers any change or query from its receipt to its implementation and publication to all stakeholders. It will also define when a change comes into effect. This CCP should be considered as flexible enough to be adapted to offer a complete process for the handling of CRs and Q&A and to enable tracking of these in a log or tracking table. The appendices to this document offer the necessary templates to be used throughout the processes. It is not intended that the CCP document should be employed definitively and in its entirety to each and every system, specification or standard, or deliverable of a project. Rather, the process is intended for use as a template that may be adapted as appropriate to different contexts, whilst maintaining the general principles. This CCP details the common steps necessary to process a CR or a Q&A. Depending on the context and nature of the subject of the Change Request, this CCP is flexible enough to allow use of all or just some of the steps in a process and all or just some of the processes.

S t a r t

S e n d

R e c e i v e

E v a l u a t e

I m p l e m e n t

P u b l i s h

E N D

Start of the change request process Send Process for sending the change request. Anyone can send a change request The change request form is annexed to this document Receive Process for receiving the change request. EMEA will receive the change request. This process is the responsibility of EMEA. Evaluate Process for approving or rejecting the change request. This process is the responsibility of the Evaluation Committee. Implement Process to implement the approved change request. This process is the responsibility of the Implementation Committee. Publish Process to release to the public the evaluated and implemented CR or Q&A. This process is the responsibility of EMEA. End of the change request process.

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SCOPE This Change Control Process (CCP) applies to any change of any system, specifications or standards defined by EMEA, the Telematics Implementation Groups, regulatory guidance or business process for projects implemented by EMEA and using RUP@EMEA methodology. It also covers any change or query from its receipt to its implementation and publication to all stakeholders. It will also define when a change comes into effect. This CCP should be flexible enough to offer a complete process for the handling of CRs and Q&A and to enable tracking of these in a log or tracking table. It will also provide in the appendices the necessary templates to be used throughout the processes, as appropriate. In line with best practices, this document takes into account the eCTD ICH change control principles (http://estri.org/eCTD/the_eCTD_Change_Control_Process_v1-8_June_2004.doc) in dealing with change requests. IT Systems hosted by EMEA and specifications, standards, guidance and business processes related to those systems, will adhere to the generic principles of this CCP. It is not intended that the CCP laid out in this document should be employed definitively and in its entirety to each and every system, specification or standard, or deliverable of a project. Rather, the process is intended for use as a template that may be adapted as appropriate to different contexts, whilst maintaining the general principles. This CCP details the common steps necessary to process a CR or a Q&A. Depending on the context and nature of the subject of the CR, this CCP is flexible enough to allow use of all or just some of the steps in a process and all or just some of the processes. As examples:

1. A Firewall Change Request: A change to a firewall may not require the employment of the publishing process. In this example, this particular process is not applicable for this type of change. Also, within the evaluation and implementation, processes could be combined, as a single committee may be sufficient to process a change of this type. Although such a change appears to be of small scale within the process, it must still be identified, sent to and received by the right person and must still be evaluated and implemented. It may also be the case that the evaluation does not require a double review cycle, but instead only one. In this case the evaluation process may be reduced to one review cycle.

2. Specification Change Request: A change to a specification document within Product Information

Management (PIM) will require all processes and all steps as laid out in this document. Appendix A Project Particulars uses PIM Data Exchange Standard (DES) as an example of how project specific information is defined.


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Appendix A - PIM Data Exchange Standard (DES)


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A. BUSINESS ACTORS For every Configuration Item1 that is subject to Change Control or Q&A, the following Actors must be identified, where appropriate:

Actors Description Evaluation Committee

The Evaluation Committee is the committee responsible for evaluating the CR. Stakeholders should be represented on this committee.

Implementation Committee The Implementation Committee is the committee responsible for implementing the CR

Change Requestor The persons who are authorised to submit a change request.

EMEA Eudra Service Desk (ESD) The function receiving the CR at EMEA for Eudra services

EMEA Information Technology Service Desk (ITSD) The function receiving the CR at EMEA for Corporate Services

Appendix A- Project Particulars could be used to further define, create or even combine the business actors. As examples:

• Firewall CR: A change to a firewall may only require one Committee with the role of the Evaluation and Implementation Committees.

• Guidance CR: A change to regulatory guidance may require adding an additional Committee,

the Publishing Committee.

1 A configuration item is a collection of objects related to the specific functionality of a larger system. Examples of these objects may be requirements, code, documentation, models or other files.


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B. PROCESS MAP This section describes the different high-level processes for a change request as previously shown in Section 2 Executive Summary. Each of these high level processes is described as a sub-process in later chapters. Reference: All examples used in the detailed description of the processes are based on a PIM Data Exchange Standard CR.

S ta r t

S e n d

R e c e iv e

E v a lu a te

Im p le m e n t

P u b lis h

E N D

Start Start of the change request process Send Process for sending the change request. Anyone can send a change request The electronic change request form is annexed to this document Receive Process for receiving the change request. EMEA will receive the change request. This process is the responsibility of EMEA. Evaluate Process for approving or rejecting the change request. This process is the responsibility of the Evaluation Committee. Implement Process to implement the approved change request. This process is the responsibility of the Implementation Committee. Publish Process to release to the public the evaluated and implemented CR. This process is the responsibility of EMEA. End End of the change request process.

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C. SEND PROCESS This process describes how to obtain, fill in and send the change request form. The Change Requestor, is the main actor in this process. EMEA becomes the change requestor where there are changes to the regulation, to the procedure or to the guidance that could impact the system or specifications. Under these circumstances, EMEA is the Change Requestor

Change Requestor

4.1.1 Obtain the Form

4.1.2 Fill in the Form

4.1.3 Send the Form

Obtain the Form It is the responsibility of the Change Requestor to obtain the CR form. The CR Form is an appendix to this document (SeeAppendix B form).

Fill in the Form The Change Requestor is responsible for filling in the change request form with at least the following information: • Title: the targeted system to which the change request refers, i.e. PIM, Eudrapharm, RDM, etc. This is

also called “Product Name” • Contact information • Change request or question information, including all information applicable:

- Category, business or Technical - Level of urgency. Low, Medium, High - Summary of the problem or clear formulation of the question, including rationale. - Item to be changed if applicable. - Version number of the system, specification, guidance or process to which the CR refers


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- Detailed description, including results of any testing. - Recommended solution, if any - Preferred implementation date if applicable

Send the Form The Change Requestor is responsible for sending the change request. The Change Requestor must send the change request form by e-mail to EMEA. Particulars of the targeted system could be an appendix to this document. A separate document or the CR form itself could be used to explain the project particulars. If the Change Requestor would like to have an e-mail receipt, the change requestor e-mail system should be configured to request a receipt (where applicable)


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D. RECEIVE PROCESS

Change Requestor Evaluation CommitteeEMEA

4.2.2 Acknowledge CR

4.2.10 Receive Acknowledgement

4.2.12 Store delivery receipt

4.2.8 Receive CR

4.2.13 Add Entry in CR & in Q&A Tracking Table

4.2.14 Publish Table

4.2.15 Announce publication 4.2.16 Receive Announcement

4.2.11 Send Delivery Receipt

4.2.1 Receive CR

[4.2.3 NCA/EMEA CR] 4.2.4 Evaluate Confidentiality

4.2.5 Remove confidentiality information

[4.2.6 Other than NCA/EMEA CR]

4.2.9 Distribute CR

4.2.7 Send Acknowledgement

Receive CR EMEA ESD/ ITSD receives the Change Request.

Acknowledge CR In the case of an e-mail, when a CR is received by EMEA, the EMEA ESD/ITSD mailbox will automatically distribute the e-mail to the person in charge of processing the CR. In the case of ordinary mail, the CR will be scanned and distributed to the person in charge of processing the CR.


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NCA/EMEA CR The change request received is from a National Competent Authority (NCA) or EMEA. EMEA ESD/ ITSD forwards the CR to the regulatory members (Member of the Evaluation Team, NCA, EC and EMEA) of the evaluation committee.

Evaluate Confidentiality The regulatory members will evaluate the information provided in the CR and identify the confidential part.

Remove confidentiality information The regulatory members will remove the confidential information. They will put additional information into the CR for clarity if needed.

Other than NCA/EMEA CR The CR received does not come from an NCA or EMEA. The EMEA ESD/ITSD is responsible for the CR acknowledgement. The mail system should be configured for delivery receipt when the receiver opens the e-mail. It is the responsibility of the requestor to always request the delivery report.

Send Acknowledgment The ESD/ITSD will send acknowledgement receipt e-mail to the change requestor.

Receive CR EMEA receives the CR and decides whether or not the CR is urgent.

Distribute CR EMEA distributes the CR to the evaluation meeting.

Receive Acknowledgement The Change Requestor receives the acknowledgement of receipt for the CR.

Send Delivery Report This task happens automatically and only if both sender and receiver use the same mail system, e.g. Microsoft Outlook. If this is the case, the Change Requestor’s mail system will send to EMEA a delivery receipt at the time they open the e-mail containing the CR acknowledgement.

Store Delivery Receipt It is the responsibility of the ESD/ITSD to store the delivery report sent by the Change Requestor in the EMEA’s change request repository.


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The ESD/ITSD will also inform the person in charge of processing the change request.

Add Entry in CR and in Q&A Tracking Table The person responsible for the processing of the CR from this point onwards will be a member of EMEA Communications and Networking Unit. EMEA is responsible for updating the CR and Q&A tracking table upon receipt of the CR and will evaluate whether it is a Q&A and/or a Change Request. The information to be added to this tracking table is extracted from the CR received:

1. In the cover worksheet: a. Next version No., draft/final, the date and the description columns need to be filled in.

If the previous version was ”in production”, the version No., draft/final, the date and the description need to be filled in. If the previous version was draft, the date will be modified and the description updated if applicable.

2. Where the CR received is a request for Q&A, a new row should be added into the Q&A worksheet with the following information:

a. Reference No. (previous + 1) in the sequence no column named “#”. b. Q&A reference no. The reference no will be a unique identifier assigned by EMEA. c. The question raised by the change requestor in the question column.

3. Where the CR received is a request for change, a new row should be added into the Change

Request table with the following information: a. Sequence No. (previous + 1) in the sequence no column named “#” b. Reference no. The reference no will be a unique identifier assigned by EMEA. c. The name of the requestor found in the Contact Information field of the CR. d. Specification component: Item to be changed field of the CR e. Description: Description field of the CR. f. Category: Category field of the CR, i.e. “Business” or Technical”

NOTE: a) Until there has been an evaluation of the change request received, the version of the CR and Q&

tracking table remains draft. At the end of the evaluation process the version will then be final. b) Where EMEA central or corporate tracking systems like clear Quest (CQ) cannot be shared live

online with external members of the Evaluation Committee, the tracking of CR and Q&A could be the worksheet proposed in Appendix B, “CR and Q&A Tracking Table”. When this is the case, at the end of the evaluation Committee procedure the ESD/ITSD will update CQ accordingly.

Publish Table EMEA is responsible for publishing the draft/final version of the CR and Q&A tracking table. The exact wording of the CR/Q&A in the tracking table may be changed during the process to provide better, clearer descriptions of what is being proposed. Often the wording used is not clear enough. The received CR will be archived in the EMEA’s change request repository. The table need to be published before the Evaluation Committee meeting and will be located in the same place as that from which the CR form can be obtained. When the tracking table is made available to the Evaluation Committee, the table will be frozen for evaluation of the change request(s) received.


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Announce Publication EMEA will send an e-mail to the Evaluation Committee notifying them of the publication of the CR and Q&A tracking table.

Receive Announcement The Evaluation Committee group receives the publication notification of the CR and Q&A tracking table. At this point the Evaluation Committee has received the detailed and summary information of new change requests.


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E. EVALUATE THE CHANGE REQUEST

Evaluation Committee Change Requestor

4.3.1 Evaluation Meeting

4.3.2 CRs Review

[4.3.4 In Scope]

[4.3.7 Accept]

4.3.6 Send Notification

[4.3.3 Not Accepted]

4.3.8 Update Tracking Table

[4.3.5 Reject]

4.3.10 Publish Tracking Table

4.3.9 Issue Impact Analysis Document


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Evaluation Meeting It is the responsibility of the chairman of the Evaluation Committee to schedule monthly meetings to deal with the CRs received. The Evaluation Committee will evaluate the change requests received. The Evaluation Committee holds regular meetings for review and evaluation of the change requests received. It is the responsibility of the chairman of the Evaluation Committee to distribute the CR and Q&A tracking table to all members of the Evaluation Committee. The table can be obtained at the “URL” where this document is located. This table should be available 5 working days before the Evaluation Committee meeting. Change requests received within 5 working days before the Evaluation Committee meeting should be processed for the following Evaluation Committee meeting. In the event that a change request received during these 5 days is identified by EMEA as urgent, it will be evaluated in the meeting. Only the form will be presented for evaluation and the table will be updated immediately after the Evaluation Committee meeting.

Review CRs It is the responsibility of the chairman of the Evaluation Committee to present each change request received. The chairman can delegate this task to a member of the Evaluation Committee if necessary. The group will decide whether or not the change request is accepted.

Not Accepted A change request is not accepted or out of scope when one or more of the following criteria are met:

1. The CR is incomplete. 2. The CR is not relevant.

In Scope A change request is in scope when it is accepted. It is the responsibility of the Evaluation Committee to decide the next version in which the “in scope” CR will be implemented and the type of version to be used. For IT systems (S/w & H/w), specifications and standards, a version is defined as follows: <product_name> <targeted delivery number> <Integration Suffix> <targeted delivery number>: Used to distinguish versions:

- x is the major release number. Major releases include changes that significantly affect a system, specification or guidance. Major releases will be identified by a new numbering sequence (e.g., 2.0.0, 3.0.0).

- y is the minor release number. In between major releases, the Evaluation Committee may propose minor releases. The scope of these minor releases will be to correct minor issues that hinder standards implementation or systems or guidance or the provision of (limited) new functionality. Minor releases will continue the numbering sequence of the last minor release (e.g., 2.1.0, 2.3.0).


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- z is a number that gets incremented every time you deliver a patch/bug fix for functionality that should have been working correctly straightaway. A perfect release with 0% error will have only one x.y.0. “0” will be increase by one at each patch or bug fix.

<Integration Suffix>. The Integration Suffix is used to distinguish versions being reviewed; this fragment is dropped when published. The <integration Suffix>is formed as follows: rc, where:

- rc is a constant meaning “candidate for review” - x is a sequence number starting from 1.

During the evaluation of a CR, it is recommended that the Evaluation Committee should take into account the dependencies between systems and business processes, such as:

- Impact on systems may impose the use of a minor or technical version independently from the type of request

- If impact on systems is severe, upgrade to minor version - If impact on systems is minimal, assess the possibility to downgrade to a technical version

The Evaluation Committee will propose the release in which a CR will be implemented. For guidance and business process documentation, normal EMEA practices on document versioning should apply.

Reject CR A change request in scope may be rejected. It is the responsibility of the Evaluation Committee to explain the reason why the change request is rejected. The tracking table will therefore be updated to mention the reason why the CR was rejected

Send Notification Where the CR is out of scope or rejected, a notification must be provided to the change requestor. All change requests rejected and out of scope will be minute in the Evaluation Committee meeting and recorded in the CR and Q&A tracking table. After the meeting, it is the responsibility of EMEA to send an e-mail to the change requestor notifying them that the CR has not been accepted (out of scope or rejected) and why.

Accept CR An accepted CR is one which is in scope and not rejected. All change requests accepted will be minute.

Update Tracking Table It is the responsibility of EMEA to update the status of the CR and Q&A tracking table following the instructions given in the minutes of the Evaluation Committee meeting.

A.1.1 Updating Change Requests (CR)

The change requests in the CR worksheet of the CR and Q&A table which have been evaluated will be updated as follows:

1. Change request out of scope. The change request will be updated as follows: a. Fill in the status with “out of scope” b. The decision date should be filled in. The decision date is the meeting date.


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Where the group decides that the CR belongs to another evaluation committee: a. Fill in the status field with “out of scope”. b. The decision date field should be filled in. c. The comment field should be filled in explaining why it should be transferred to another

evaluation committee. c. The action and flag fields should be left blank.

2. Change request rejected. The change request will be updated as follows: a. The comment field should explain why (“the reason”) the change request is rejected. b. The status field should be filled in with “rejected”. c. The action field should be left blank. d. The decision date field should be filled in.

3. Change request accepted. The change request will remain in the table and will be updated as follows:

a. The status field should be filled in with “accepted” b. The action field should be filled in, indicating when and in which version it will be

implemented. c. The comment field could be left blank or filled in if the group feels the need to add additional

clarification. d. The decision date field should be filled in. e. The Urgent Flag field should be set to “Y” if the group decides that the change is urgently

needed. Where the group decides that they need additional help to resolve the change request (e.g. additional business/technical input) the change request will be marked as deferred:

d. The status field should be filled in with “deferred”. e. The decision date field should be filled in. f. The action, comment and flag fields should be left blank.

Where the group decides that the CR is a Q&A and there is no need for a change, the CR is transferred to the Q&A worksheet. In this case, the Evaluation Committee may change the content for clarity reasons and record the Q&A as a new entry and link the CR and the Q&A with their references.

A.1.2 Updating Questions and Answers

The change requests in the CR worksheet of the CR and Q&A table which have been evaluated will be updated by providing the agreed answer and introducing the approval date. If applicable, the evaluation field of the CR form will be updated. This field can be used to provide additional information to ease the understanding of the CR.

Issue Impact Analysis Document The Evaluation Committee will undertake the responsibility of delivering an impact analysis on systems and resources of the accepted CRs.

Publish tracking Table It is the responsibility of EMEA to publish the updated table after the Evaluation Committee meeting.


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F. IMPLEMENTATION OF THE CHANGE REQUEST Implementation CommitteeEvaluation Committee

4.4.2 CR Meeting

4.4.3 CR Review

[4.4.6 CR Clear]

[4.4.4 CR Not Clear]

4.4.12 1st Review Request

4.4.13 Incorporate Comments

4.4.16 2nd Review Request

4.4.5 Request CR Clarification

4.4.11 Provide Technical Proposal

4.4.18 Sign-off Proposal

3.4.23 Draft Release

[4.4.15 CR Not Urgent] [4.4.14 CR Urgent]


4.4.21 Incorporation of Final Comments

[4.4.20 Sign-off Comments]

[4.4.19 Signed Off]

4.4.22 Technical Proposal - Final

4.4.1 CR Accepted

4.4.8 Provide CR Rejection Report

[4.4.7 CR Not Feasible]

[4.4.10 CR Feasibile]

4.4.9 Update Tracking Table Request


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CR Accepted The change request is accepted and needs to be implemented.

CR Meeting It is the responsibility of the chairman of the Implementation Committee to schedule regular meetings to deal with the CRs accepted. The Implementation Committee will implement the change requests accepted. The Implementation Committee holds if necessary, a monthly meeting scheduled for review and implementation of the change requests received from the Evaluation Committee

CR Review The Implementation Committee will review the accepted change requests to:

1. Acknowledge understanding of the request. 2. Provide a proposal. 3. Provide estimates for implementation proposal.

CR Not Clear Where an accepted CR is not completely understood by the Implementation Team, the Evaluation Committee will be requested to provide further clarifications. The chairman of the Implementation Committee will request this clarification to the chairman of the Evaluation Committee via e-mail. In the event the Evaluation Committee and the Implementation Committee are the same, a clarification must be found in order to progress the CR.

Request CR Clarifications When the Implementation Committee requests clarifications on a specific accepted change request, the Evaluation Committee will provide clarifications as soon as possible, e.g. within 5 working days and the resolution of the CR will be postponed to the next Implementation Committee meeting. If the CR is urgent, an ad-hoc teleconference will be set up with both Evaluation and Implementation Committee representatives to clarify the CR. After this period, if no clarification is provided, the CR will be rejected with the reason given as: “not enough information to provide technical proposal”.

CR Clear The Implementation Committee understands the change request and therefore a proposal for implementation can be made.

CR Not Feasible The Implementation Committee understands the CR but it cannot be implemented, for example, due to incompatibility issues, conflict with the regulation, etc.


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Provide CR Rejection Report The Implementation Committee will provide via a CR Rejection report, the reason(s) why a CR cannot be implemented. This report will be sent to the Evaluation Committee.

Update Tracking Table Request The Evaluation Committee will update the table for CRs that cannot be implemented. This CR is considered “rejected” and the reason(s) are the ones explained in the CR Rejection report. The activity to update the Tracking Table is a repetition of activity 0.

CR Feasible The Implementation Committee understands and can implement the CR.

Provide a Technical Proposal The Implementation Committee will prepare a document providing a technical proposal for each of the accepted change requests. This document is distributed to the Evaluation Committee no later than three days after the Implementation Committee meeting. This proposal will include, where appropriate and for each CR:

A roll back position Time restriction if applicable Documentation affected as part of this process

1st Review Request The Evaluation Committee receives from the Implementation Committee a technical proposal document addressing the received CR for review. A period of 10 working days is recommended for the first review. This period may vary depending on the nature and context of the CR. An urgent CR may take this first review cycle for information purposes due to the urgent need for implementation.

Incorporate Comments (1st Review) At the end of the 1st review period, the Implementation Committee will incorporate comments received, if any, into the proposal document and prepare a final proposal for the 2nd and final review. Urgent change requests are reviewed only once. After the first review cycle, comments will be incorporated for implementation. If there are no comments on the proposal, the Implementation Committee will start preparing a draft proposal for publication.

CR Urgent An urgent CR is reviewed only once by the Evaluation Committee.


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CR Not Urgent CRs which are not urgent and which were commented upon during the 1st review cycle will be reviewed a second time.

2nd Review Request The Evaluation Committee receives a technical proposal document for review from the Implementation Committee.

Incorporate Comments (2nd Review) At the end of the 2nd review period, the Implementation Committee will incorporate any comments received into the proposal document and implement the proposal. This is the last review cycle. If no objections but some constructive comments are received, the Implementation Committee will implement the technical proposal taking into account all comments received. The technical proposal document will be updated with all comments received and sent to the Evaluation Committee for sign-off.

Sign-off Proposal The Evaluation Committee will receive the second version of the proposal document from the Implementation Committee. A proposed time period for signing off the proposal could be 5 working days. This will depend on the context and the nature of the CR. At the end of the sign-off period, if there is no answer, it is assumed that the document is signed-off. In the case that there are outstanding issues for a particular CR that prevent sign-off, the CR will be removed from the implementation scope and addressed at the next release.

Sign-off The Evaluation Committee has no comments on the technical proposal document.

Sign-off Comments Comments received from the Evaluation Committee during the final sign-off period, if any, will be incorporated and eventually addressed in the draft release.

Incorporation of Final Comments Comments during the sign-off process will be incorporated in the technical proposal document.

Technical Proposal – Final The final version of the technical proposal is distributed to the Evaluation Committee.

Draft Release The Implementation Committee will deliver a new version of the production release incorporating the technical proposal signed off The following list is an example of what deliverables should be provided by the Implementation Committee:


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1. The specifications document if applicable e.g. style-sheets, DTD, Schemas, etc. 2. The unit test of requirements implemented. 3. System Test Report 4. UAT Report. 5. Guidance to stakeholders on moving from the previous version to the new proposed production

version. These deliverables will be packed in a zip file and will have the following naming convention as defined in the previous chapter:

Product Name or Targeted System <Targeted Delivery Number>< Integration Suffix>

Example: There is agreement on the next version release, PIM DES 2.3.0 First Implementation proposal will be PIM DES 2.3.0.C1 Second implementation proposal will be PIM DES 2.3.0C2

< Integration Suffix> is never displayed in the production release. It is only tagged during the review cycle. The implementation proposal for the CR form will be updated. The information in this should be a summary of the proposed implementation.


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G. PUBLISH EMEAImplementation CommitteeEvaluation Committee

4.5.2 Publish Draft Release

4.5.3 Public Review

4.5.14 Production Release


4.5.6 Review Comments & Sign-off


4.5.9 Send Publication Proposal

4.5.10 Build Production Release

[4.5.1 CR Not Urgent]

[4.5.11 CR Urgent]

[4.5.4 Public Comment]

[4.5.13 No Sign-off Comments] [4.5.7 Sign-off Comments]

[4.5.12 No Public Comments]


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CR not Urgent The change request will not be processed as urgent and will follow the public review period.

Publish Draft Release EMEA publishes the draft release on the EMEA Website, including the draft “Release notes” document.

Public Review The Draft Release will be published for public consultation for a period of three weeks.

Public Comments During the consultation period, public comments are received and need to be reviewed.

Incorporate Comments The Implementation Committee will organise a meeting to evaluate and potentially incorporate the comments received in the technical proposal document.

Review Comments & Sign-off The Evaluation Committee will receive the technical proposal document updated with the public consultation. They will have a minimum of 5 working days for review.

Sign-off Comments The Evaluation Committee sends comments to the Implementation Committee.

Incorporate Comments The Implementation Committee incorporates the comments received from the Evaluation Committee in the technical proposal document.

Send Publication Proposal The Evaluation Committee receives the final version of the documentation for production, implementation and publication,

Build Production Release The Implementation Committee will build the production release taking into account all comments received.

CR Urgent An urgent change request does not follow the public review.


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No Public Comments Go directly to sign-off

No Sign-off comments The Evaluation Committee group has no comments on the public review.

Production Release The Implementation Committee sends the final production release to EMEA for publication. The production release is published within 5 working days.


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APPENDIX B: EMEA CHANGE REQUEST FORM Title1

Contact Information Organisation Name: Organisation Address:

Contact Name: Address:

Telephone Number: E-mail Address: Question or Change Request Category Business/Technical Level of urgency Low/Medium/High Summary This should be a short summary of the problem submitted including rationale. Submit Date Date you submit the change request (YYYY-MM-DD) Item to be Changed/ Question

Reference to the Product Name of the specification to be changed (e.g., the eCTD DTD, the written specification, the M2 eCTD style sheet)

Version Number and Date

Indicate the specific version and date of the Specification or standard, system, guidance, etc., for which the change is proposed.

Description Provide a detailed explanation of the problem, and steps on how to recreate the error, if applicable. If this is a new requirement or enhancement, please provide the reason for the requirement or enhancement and any known solutions. If you have any sample output, sample code or other examples to help clarify the description, attach the samples to this form. You should also provide a detailed description of any testing or research that was done to support the solution(s) being proposed and any advice on backward compatibility issues.

Recommended solution, if any

Provide a detailed explanation of any known solutions

Preferred Implementation Date

Following the level of urgency, provide the preferred implementation date

Evaluation Assessment

To be filled in by the Evaluation Committee. Provide additional information to clarify the description of the CR given by the change requestor if applicable.

Implementation Proposal

To be filled in by the Implementation Committee. Provide a summary of the proposed implementation.

Submit a completed electronic copy of this form to EMEA. Refer to the appropriate Project Particulars section to obtain the e-mail address. Alternatively send it by post at the following address: EMEA Communication and Networking Unit 7 Westferry Circus, Canary Wharf UK - London, E14 4HB

1 Title should specify the Product Name the CR or Q&A refers to, e.g. PIM, eCTD EU M1, eAF, EudraCT, RDM, Eudrapharm, etc


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APPENDIX C: EMEA CHANGE REQUEST TRACKING TABLE Q&A and CR worksheets version control

EU Region M1 PIM Question and Answer and Specifications Change Request Document

Version 0.0

mm 2007

Document Change History

Version Number Date Description


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Q&A Worksheet # CR

Ref No

Ref No Question Answer Approval Date


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CR Worksheet # Q&A

Ref No

Ref No. Requestor Specification Component

Description Comments Category

Status Decision Date

Urgent Action

Business Accepted Yes Technical Rejected No Out of Scope deferred


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CHANGE REQUEST PROCESS - PROJECT PARTICULARS

Project: PIM PIM Data Exchange Standard (DES) and PIM Validation Specifications

Evaluation Committee: eCTD Interlinking2. PIM Core Team3 (CT) acting as Evaluation Committee on behalf of the eCTD Interlinking group.

Implementation Committee: PIM DES Team Publication: EMEA Signatory. The signatory is the Core Team (CT). The CT is responsible for endorsing/rejecting the

evaluated CR. o Normal: CT Meeting. o Urgent: e-mail

Issue Management o CR Form o Clear Quest (CQ) for the PDVE. CQ is the internal tracking system for software development o Q&A Table

Deliverables o Work plan collecting all the information and recording all discussion of CRs accepted for

implementation. o CR Form updated o CR and Q&A Table updated o Unit Testing (UT) o Example Coverage against the UT o Two DES examples o Specifications o Guidance to upgrade from a previous version

PIM Review System (PRS)

Evaluation Committee: Regulators members from the Core Team Implementation Committee: EMEA Publication: EMEA Signatory: Regulators members of the Core Team. These members are responsible for

endorsing/rejecting the evaluated CR. o Normal: Core Team meeting. o Urgent: e-mail

Issue Management o CR Form o PRS: Clear Quest (CQ)

Deliverables o CR Form updated o CR and Q&A Table updated o System Test Report o UAT o Other related documentation when required, e.g. requirements, guidance, etc.

2 Description of the eCTD Interlinking group can be found at http://draft-esubmission.emea.europa.eu/tiges/ectdinterlinking.htm 3 Description of the CT, DES and LAT can be found at http://draft-esubmission.emea.europa.eu/tiges/pimct.htm


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PIM Light Authoring Tool (LAT) and PIM DES Validation Engine (PDVE)

Evaluation Committee: PIM LAT Team Implementation Committee: EMEA Publication: EMEA Signatory: Industry member of the Core Team and EMEA. These members are responsible for

endorsing/rejecting the evaluated CR. o Normal: CT meeting. o Urgent: e-mail

Issue Management o CR Form o PRS: Clear Quest (CQ)

Deliverables o CR Form updated o CR and Q&A Table updated o System Test Report o UAT o Other related documentation when required, e.g. requirements, guidance, etc.

General Points for DES, PRS and LAT Frequency for releases:

Major. In principle not more frequent than every two years. Minor. Twice a year due to the revision of QRD templates which are reviewed two times a year. Bug fixing. As required.

Internal review periods:

Normal: 10 working days except of emergency cases. Urgent: As soon as possible

Public Consultation: Where public consultation is required, the consultation period will be of three weeks Frequency of face-to-face meetings or teleconference:

Evaluation Committee: Monthly if necessary except of emergency cases Implementation Committee: Monthly if necessary except of emergency cases.

The tracking table will be made available by the EMEA 5 working days before the Evaluation Committee meeting and will be located in the same place as that from which the CR form can be obtained. EMEA will publish the updated table within 5 working days after the Evaluation Committee meeting. Required processes: All (Send, Received, Evaluate, Implement and Publish). Submit a completed electronic copy of the CR form in Appendix A to [email protected]

mailto:[email protected]


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DOCUMENT INFORMATION

Open Issues (None)

Document Location EMEA

Document ID EMEA/342717/2006

Referenced Documents Doc ID Title Guideline-EMEA/99744/2004 EMEA Version Control Policy EMEA/347133/2006 v1.1 Draft Term of Reference Interlinking-mandate-final.doc v1.0 eCTD Interlinking Group, MANDATE AND WORKING METHODS EMEA/472493/2006 EMEA IT OPS-Eudra CC Request EMEA/472277/2006 EUD021 Change Control v1-0 EMEA/276807/2006 Change Advisory Board Change Request Template v0.2 EMEA/121892/2006 CAB Change Request Register EMEA/469205/2006 EU eCTD Q&A and Change Requests v1.7 EMEA/476395/2006 Analysis on Release Strategy for Production Systems and CCP of EU

Telematics Projects

Document History Version Who When What 0.1 JRM 29 Aug 06 Initial Draft 0.2 JRM 14 Aug 06 Second Draft 0.3 JRM 15 Aug 06 Incorporate Neil Cordwell comments 0.4 JRM 07 Dec 06 Extend scope to EU Telematic and incorporate comments from the PIM CT (

APM-FH-LD) 0.5 SEA 12 Dec 06 Quality check 0.6 JRM 12 Dec 06 EMEA Internal meeting on CCP harmonisation 0.7 JRM 18 Dec 06 CT and Internal comments 0.8 OS 22 Dec 06 Reviewed. 0.9 JRM 15 Jan 07 OS and MB comments 0.10 WN 22 Jan 07 Reviewed 0.11 JRM 09 Feb 07 Comments from RDM - WN – APM – EN quality check (SEA) 0.12 JRM 19 Mar 07 PIM Project particulars and section 4.2.9 & 4.3.9 0.13 JRM 21 Mar 07 Sections 4.1.1, 4.1.2, 4.2.13, 4.2.14, 4.3.8, 4.3.10, 4.4.2 and Appendix A 0.14 JRM 0.15 JRM 8 May 07 NC Comments 0.16 MB 28 Feb 2008 1st Updated in line with the requirements from the EMEA Standards Committee

(STANCO) prior to the final adoption of this document as version 1.0 0.17 MB 29 Feb 2008 2nd Updated in line with the requirements from the EMEA Standards Committee

(STANCO) prior to the final adoption of this document as version 1.0 0.18 TB 13 Mar 2008 Final review; Track changes left in 1.0 TB 13 Mar 2008 Accept all changes; Final

Document Distribution Version When Who

0.6 12 Dec 06 PIM Core Team 0.7 12 Dec 06 EMEA PM Sector 0.11 9 Feb 06 EMEA IT Sector


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0.13 21 Feb 06 EMEA CAB, PIM CT, eCTD Interlinking and TIGes-J 0.15 18 Jul 07 PIM CT 0.16 28 Feb 2008 None 0.17 29 Feb 2008 STANCO Board prior to final release

Filename: EMEA Change Control Process.doc Directory: H:\Temp files - delete when saved\esub Template: C:\Documents and Settings\simoen.EMEA\Desktop\Template 01

EUP.dot Title: Subject: General-EMEA/342717/2006 Author: Keywords: Comments: Creation Date: 22/11/2007 11:46:00 Change Number: 23 Last Saved On: 13/03/2008 09:16:00 Last Saved By: zzwasadmin Total Editing Time: 236 Minutes Last Printed On: 24/04/2008 13:59:00 As of Last Complete Printing Number of Pages: 39 Number of Words: 7,831 (approx.) Number of Characters: 40,800 (approx.)