Workshop Questionaire

# 1

Requirements Workshop

# 2

Agenda

Day Time

Topic 1 1 9:00-10:00 amTopic 2 1 10:00- 1:00 pmTopic 2 2 9:00- 9:30 amTopic 2 2 9:30- 1:00 pm<if possible, schedule half-day sessions>

Day 1

Day 2

# 3

Project Goal

<Enter Project goal>

# 4

Project Deliverables

• <List project deliverables>

# 5

Definitions

• What are Documents?• What are Docbases?• What are Cabinets and Folders?• What is a Workflow?• What are the User Types?• <Others…>

# 6

DefinitionsWhat are Documents?

• A written or printed paper, a recording, a file, or a photograph that bears the original, official, or legal form of something and can be used to furnish information

• A document can have attributes that describe it such as: subject, authors, drug name, case number, etc. (Attributes are information used to search for the documents)

• Documents can be related with other documents

• Documents can be different formats: text, graphics, spreadsheets, video, voice, etc.

# 7

Definitions What are Docbases?

• Documents and its attributes are stored in a central electronic repository• Documentum (a Document Management System vendor) calls its repository Docbase• The Docbase resides on a UNIX or an NT server• The Docbase stores a document’s contents and any information associated with it

# 8

DefinitionsWhat are Cabinets and Folders?

• Documents can be organized in a logical, cabinet/folder structure

• Actual document location and file names are transparent to the user

• Cabinets have the highest level of document organization (it contains folders and documents)

• Folders contain folders and documents (unlike the network file structure, a single document can be referenced in multiple folders)

# 9

DefinitionsWhat is a Workflow?

Authoring Doc. Control Review

Work-In-Progress

ReleasingDocuments

Approval

Approval

Approval

ApprovalAutomatic Routing & Notification

DocumentumDocbase

View Documents

Searching & Viewing

# 10

DefinitionsWhat are the User Types?

What are the User Types:1. Author - view, create, modify & delete rights to documents

(any changes to a document needs to be routed)2. Document Control - view, create, modify & delete rights to

documents and data (any changes to a document needs to be routed)

3. Approvers - view & approve rights to documents4. System Administrator- super-user rights to the Docbase5. Consumers - end user of the documents

DocumentControl

Author

Approver

Approver

DocumentControl

ApproverSystem

Administrator

Consumers

# 11

Design Questions(Sample questions)

• Authoring• Document Change Notice (DCN) or ECN• Routing and Approval• Viewing Documents• Security• System Maintenance

# 12

Authoring

1. Is collaboration with co-authors required? Internal and external?

2. If yes, will there be an assigned author?

3. If yes, can collaboration be handled outside Documentum through e-mailing, meetings, and/or online white boards (e.g. MS NetMeeting)?

4. Can Reviewers review documents outside Documentum, through e-mailing, meetings, and/or online white boards (e.g. MS NetMeeting)?

5. Do Reviewers have to sign the electronic copy prior to the approval process?

6. Can an Author check out a prior version?

7. If yes, do you have multiple versions?

8. Do you have the concept of Target Effective Date?

Authoring

Collaboration with co-author(s)

Discussions and walkthroughs withreviewers

Registering ofdocument(s) toDocumentum

Create or modify document(s)

# 13

Authoring

Authoring





11. Can an Author check out a document that has been approved but not yet implemented?

12. When creating a new document, can the Author copy from an existing version? Can he/she copy from a template? How are templates defined?

13. Can the Author cancel a checked out document without saving his/her work?

14. Are there “non-controlled” documents that are in the system but do not require a formal approval process?

15. When an Author checks out a document, is there a need to send out notification?

16. Are notifications sent through email?

17. How is the unique document number created?

18. What are the document formats?- MS Word, Excel- BMPs, PICs, TIFFs, JPEG

19. Are there OLE link files?

# 14

Authoring

Authoring





21. Is there a need for document templates?

22. Is there a concept of temporary documents?

23. If yes, does the Author specify an expiration date? (What happens to the document when it is about to expire? What happens when it does expire?)

24. Can the Author change the expiration date when the document is already ‘active’?

25. If a temporary document is created, how does it affect checked out documents?

26. Is there a need to relate documents?

28. What are the document attributes associated to a document?

29. Are there any multiple value attributes?

30. Will the system assign version numbers/letters?

# 15

Authoring

Authoring





31. If yes, what determines the version numbers/ letters?

32. Can Authors obsolete a document?

33. If yes, is there a need to replace the obsoleted document with a new document?

34. Can an Author reactivate an obsoleted document?

35. Do documents need watermarkings and header information?

36. Is there a need to keep revision markings on modified documents for approval purposes?

37. If yes, do you keep the revision markings after the document has been approved? or implemented?

38. What document applications need to be linked with Documentum?

# 16

DCNs

1. Can unique DCN numbers be generated by the system?

2. Are there different DCN types with unique features? - New or modified documents - Obsolete - Temporary

3. What are the DCN attributes?

5. What are the DCN and document attributes that assign a workflow and a notification list

6. Can an Author add approvers to an existing list? Can he/she change the approval route?

7. Is there a need to provide specific instructions for each approver?

8. Is there a need for proxies?

9. Is there a concept of Batch DCN that have the same effective date but different approval routes?

Author

• Creates an electronic DCN• Associates registered document(s) to the DCN

# 17

DCNs

11. Can the Author cancel an in-process DCN?

12. What are the different status of a DCN?

13. Is there a need to monitor DCN status?

14. Is there a need for Doc. Control review?

15. If yes, should Doc. Control modify the DCN and the associated documents?

16. Will there be physical items such as drawings or software associated with the DCN?

Send

Doc. ControlReview

<RejectResend>Originator

• Creates an electronic DCO• Associates registered document(s) to the DCO

# 18

Approval Process

1. Will the approval flow be parallel? or serial?

2. Will the routes include sub-routes? forwarding?

3. Should the approvers have the ability to approve or reject?

4. Should the approvers be prevented from modifying the documents while the DCNs are on route?

5. Can a DCN be sent to a group or individual?

6. If the DCN is sent to a group should the notification be approved by all members or by the first one to approve the document?

7. Is there a need to add, delete or change approvers while the DCN is on route?

8. If yes, is it GMP compliant?

9. If an approver fails to approve a DCN within a period of time, is there a need to escalate?

10. Is there a need for approvers to enter annotations to a document?

11. Should modified documents be viewed with revision and banner markings?

Approval

Approval

Approval

Doc. Control

# 19

Approval Process - If Rejected

1. Do all approvers need to review the DCN before returning the DCN to the Author or Doc. Control?

2. When an DCN is rejected, who are notified?

3. Is there a need to enter comments when the approver rejects a DCN?

4. Is there a need to maintain an audit trail of a DCN?

5. Can the DCN reuse the same DCN number?

6. If there is a concept of a Batch DCN, is there a need to reject all the DCNs in the same batch if at least one of the DCNs is rejected?

Author

Approval

Rejected

Resend

Doc. Control Rejected

# 20

Approval Process - If Approved

1. Is there a need for a Doc. Control step?

2. If there are comments and annotations, should they be removed?

3. If there is a concept of a Batch DCN, should the system hold all DCNs prior to releasing the documents?

4. Should the system write a ‘Released’ watermark on the document when it is released?

5. If there is a concept of implementation date, should the system change watermarkings of the new and old versions? Can a user modify the implementation date?

6. Is there a need to update other systems (e.g., ERP)?

Released

Doc. Control

Notifies appropriateusers that the document(s)have been released

Updates other systems

Approval

Approval

Approval

# 21

Viewing Documents

1. Should the user be able to search for a document (and DCN) using any combination of document attributes?

2. Should full-text searching be allowed?

3. Is there a need for a quick search feature?

4. Should the users be able to save searches?

5. Should Doc. Control be able to create complex searches?

6. Should users be able to view version history?

7. Should users be able to view status of a document that is being reviewed?

8. Should documents contain ‘Official’, ‘History’, Obsolete’ watermarking?

9. Should users be able to view related documents? Where Used?

10. Can users add comments to a document while it is ‘Official’?

11. Should users be able to access the documents through the intranet and internet?

12. Is there a need to have a common login name and password with other systems?

DocumentumVault

View Documents

# 22

Security

1. What will determine who has access to the document and the level of access that they will have?

User Role

SystemAdministrator

Author(s)

Approvers

Satellite Coordinators

World

D o c u m e n t S t a t u s

Draft In RF For Approval Approved Effective Superceded Suspended/Obsolete

None

Delete

None

Delete

None

None

Read

Read

None

Delete

None

None

Read

Read

Relate

Read

None

None

Version

Read

Read

Read

None

None

Version

Version

Read

Read

Read

Version

Read

None

None

None

None

None

Read

None

None

None

None

NoneResponsibleDepartment

# 23

System Maintenance

Satellite Coordinators

4.1.1.1 Will Document Control be responsible for defining and maintaining document templates for their functional areas?

4.1.1.2 Will Document Control be responsible for defining and maintaining attribute picklists for their functional areas?

4.1.1.3 Will Document Control be responsible for defining and maintaining workflow routes and alternative approvers for their functional areas?

4.1.2 Will Document Control be responsible for facilitating workflows whenever necessary?

4.1.3 Should Document Control have the ability to generate reports?

4.1.4 Should Document Control have the ability to cancel checkout on behalf of other users?

Document Control

# 24

System Maintenance

The System Administrator

4.2.1 Will the System Administrator be responsible for defining and maintaining Users, Groups, and Security?

4.2.2 Will the System Administrator be responsible for maintaining the DMS Oracle database and Documentum objects?

4.2.3 Will the System Administrator be responsible for migrating the DMS application from a development to testing environment, and then to a production environment?

4.2.4 Should the System Administrator be able to perform complex searches when necessary?

# 25