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Cordis Franchise Method 12519156 Rev: 1

DCR: 12567804 Effective: 7/29/2011
MD&D ADAPTIV Master Validation Index and Validation Document Procedure
12519156.R1_doc.pdf (1 file(s) total).
MD&D ADAPTIV
MASTER VALIDATION INDEX & VALIDATION
DOCUMENT PROCEDURE
Purpose ...................................................................................................................................................2
Scope ..................................................................................................................................................... 2
Business rule for revising this document ............................................................................................2
Definitions, Acronyms, Abbreviations..................................................................................................2
Roles and Responsibilities ....................................................................................................................2
References ..............................................................................................................................................2
Icons ........................................................................................................................................................4
Master Validation Index (MVI) ................................................................................................................5
Overview .............................................................................................................................................5
Locating MVIs .....................................................................................................................................5
Role......................................................................................................................................................5
MVI Relationships ..............................................................................................................................6
Part and Test Method MVI..................................................................................................................6
Project MVI ..........................................................................................................................................7
Category List ......................................................................................................................................8
Validation Documents ..........................................................................................................................12
Overview ...........................................................................................................................................12
Locating Validation Documents......................................................................................................13
Role....................................................................................................................................................13
Types .................................................................................................................................................13
Relationships ....................................................................................................................................13
Category List ....................................................................................................................................15
Appendices ...........................................................................................................................................20
Process Flow for Validation Documents........................................................................................20
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Purpose
The purpose of this procedure is to provide an overview of Validation

Documents and the Master Validation Index (MVI) within ADAPTIV.
Scope
This procedure applies to all Johnson & Johnson Medical Device and
Diagnostics Franchises that use the ADAPTIV Product Lifecycle
Management (PLM) system.
This procedure is a high level introduction to what MVIs and Validation
Documents are and how they are managed within ADAPTIV. Detailed
instructions can be found in related subordinate Work Instructions.
Business rule for

revising this
document
This document must be revised and maintained in accordance with the

MD&D ADAPTIV Managing Shared P&P Procedure.
Definitions,
Acronyms,
Abbreviations
Refer to the MD&D ADAPTIV Glossary of Terms for information regarding

Definitions, Acronyms, and Abbreviations.
Roles and
Responsibiliti
es
Refer to the MD&D ADAPTIV Glossary of Terms for

information regarding Roles and Responsibilities.
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References
Document
Number
Document Name
The following documents either support this procedure and/or are referenced in this
procedure:
12520652
MD&D ADAPTIV Navigating Projects Work Instruction
12519120
MD&D ADAPTIV Working With Projects Work Instruction
12519122
MD&D ADAPTIV Stage Gate Procedure
12519157
MD&D ADAPTIV Master Validation Index Work Instruction
12520677
MD&D ADAPTIV Validation Document Work Instruction
12519173
MD&D ADAPTIV Basic Navigation Work Instruction
12519126
MD&D ADAPTIV Change Order Work Instruction
12520689
MD&D ADAPTIV Change Project Work Instruction
12520651
MD&D ADAPTIV Managing Project Work Instruction
12519179
MD&D ADAPTIV System Configuration Work Instruction
12574520
MD&D ADAPTIV Managing Shared P&P Procedure.
12519172
MD&D ADAPTIV Glossary of Terms
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Icons
ICO
N
DESCRIPTION
Master Validation Index (MVI)
Edit (Properties Actions Menu)
Copy (Properties Actions Menu)
Cancel (MVI & Validation Document Properties
Actions Menu)
Delete (MVI Components Actions Menu)
Delete Latest Revision (Validation Document
Properties Action Menu)
Delete This Version (File Attachment Actions
Menu)
Delete All Versions (File Attachment Actions
Menu)
Non Product Software Part
Non Product Equipment Part
Non Finished Good Part
Finished Good Part
Document [Test Method]
Stage Gate Project
Change Project
Create (MVI Components Actions Menu)
Add Existing (MVI Components Actions Menu)
Disconnect (MVI Components Actions Menu)
Protocol
Protocol Supporting Documentation (PSD)
Report
Letter to File
Summary, Evaluation, Assessment (SEA)
Validation Documentation
Upload/Check In (File Attachment Actions
Menu)
Update Files (File Attachment Actions Menu)
Download (File Attachment Actions Menu)
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Master Validation Index (MVI)
Overview
The Master Validation Index is an ADAPTIV system object that provides a

consistent approach for the control and management of the group of nonChange Order controlled objects referred to as Validation Documents
(e.g., Protocols, Protocol Supporting Documentation (PSD), Reports,
Letters to File (LTF), Summaries/Evaluations/Assessments (SEA), and
other Validation Documentation). Organization and control is maintained
because Validation Documents may only be created from within an MVI,
and because the ability to create an MVI is limited to individuals with the
appropriate role within ADAPTIV.
The approach or strategy toward the use of the MVI within ADAPTIV may
be determined at the Franchise level. ADAPTIV is flexible and enabling
with respect to the use of the MVI. The specific strategy may include, but
is not limited to, the following approaches:
Locating
MVIs
Role
Classifications of MVIs
Who within the organization may create MVIs
Which system objects are associated with MVIs
The use of stand-alone MVIs
Users with the appropriate role can locate existing MVIs and run system
level reports for all MVIs that they own through the Global Toolbar My
Desk menu. Other existing MVIs can be located through the Category
List of a related Part, Project, or Test Method, or by using the standard
search function within ADAPTIV.
In order to manage MVIs you must have the role of Validation MVI
Author in ADAPTIV. Validation MVI Authors can create new MVIs, and
they can edit any MVI in the system in the Exists state within their
Franchise. The Validation MVI Author can also transfer ownership of an
MVI to another user with the Validation MVI Author role.
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MVI
Relationships
An MVI can be created from the Global Toolbar Actions menu as a standalone object. A stand-alone MVI can be used to group together Validation
Documents for a functional department, a site, a facility, a utility, etc. An
MVI can also be created directly from the Category List of Parts, Test
Methods, and Projects.
When created directly from these objects, an MVI to object relationship is

established by ADAPTIV. An MVI for a Part, Test Method, or Project can
also be initially created as a stand-alone MVI, and the relationship
established later with the appropriate objects in the ADAPTIV system.
Refer to MD&D ADAPTIV Master Validation Index Work
Instruction for detailed guidance on how to create and associate
MVIs.
Part and Test The documentation (Validation Documents) necessary to develop, study,
Method MVI
evaluate, assess, summarize, or validate a Part or Test Method can be
associated with the Part or Test Method through its MVI. When the Part or
Test Method is used in other relationship structures (e.g., DMR or BOM), the
link to its Validation Documents is maintained in the related MVI and can be
easily found in the relationship structure.
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Note: The graphics contained within this document are for

illustration only; the values, attributes, and range holders
within these graphics may or may not pertain to your specific
franchise
Project MVI
The documentation (Validation Documents) necessary to develop, study,

evaluate, assess, summarize, or validate the product or process can be
associated with the Project through its MVI. Those Validation Documents
that appear in the Projects MVI may be associated with Stagegate Project
Activities and added to a Project DHF/Controlled View.
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Category List
All MVIs display the following categories in the Category List: Properties,
Lifecycle, MVI Components, Where Used, and References.
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Properties
Properties (
MVI Class: Number)
Attributes - All MVIs have the following Attributes defined on the

Properties page:
Number
Title
History
Description
Owner
State
Class
Sub Class
Franchise
Operating Company
Business Unit
Site
Vault
Actions Users with the appropriate role may perform the following
actions from the MVI Properties category:
ACTION
DESCRIPTION
Edit
Edit the available MVI Attributes.
Copy
Create a copy of the MVI. All of the MVI Components

from the original MVI are copied to the new MVI.
The References attached to the original MVI are not
transferred to the new MVI.
Lifecycle
Cancel
Cancel an empty MVI. The system displays an error

message if Validation Documents are associated with
the MVI. If no Validation Documents are associated
with the MVI, the system prompts for a Reason for
Cancel, and then changes the MVI State to Cancel.
Search
Within
Search for all Validation Document types within the

current MVI using the system search engine
The Lifecycle category displays the current state of the MVI. There are
three Lifecycle States for MVIs: Exists, Retired, and Cancel. The
default state for an MVI at the time of creation is Exists. Business
practice may require MVIs to be moved to the Retired state or Cancel
state.
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DCR: 12567804 Effective: 7/29/2011
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Refer to MD&D ADAPTIV Master Validation Index

Work Instruction for detailed guidance on how and when a MVI
state can be changed.
MVI
Components
The MVI Components category allows users with the appropriate role
to associate specific Validation Documents (i.e., Protocols, SEAs, and
other Validation Documentation) with the selected MVI.
The
association can be accomplished by creating new objects or by adding
existing ones. The same Validation Document may be linked to
multiple MVIs. Although there is no limit to the number of Validation
Documents that can be related to an MVI, the recommended maximum
is about 300 Validation Documents per MVI in order to avoid impact to
system performance.
Refer to MD&D ADAPTIV Master Validation Index
Work Instruction and MD&D ADAPTIV Validation Document
Work Instruction for detailed guidance on how to create and
associate MVI components.
Where Used
The Where Used category displays all Projects, Test Methods, Parts,
Document, etc. reference relationships associated with the selected
MVI.
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References
Users with the appropriate role can add Documents, Parts, or other
MVIs as references to a selected MVI. Once the Reference linkage is
established, the reverse linkage can be seen in the Where Used
category in the Category List of the referenced object.
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Validation Documents
Overview
Validation Documents are objects that can only be created from within the
context of an MVI, are revision controlled, and go through an approval
cycle, but are not approved through a Change Order. Validation
Documents include the documentation used to detail and support the
results of the design efforts at each phase of development as well as all
verification and validation documentation for products, processes, test
methods, software, equipment, facilities and utilities.
Validation Documents are used to record proof or evidence of the full
understanding and approval of the finished design. During development,
this proof can be documented in Protocols and their associated Reports:
Proof that a concept is feasible
Proof that a prototype can be built
Proof that a product is competitive with other devices
Proof that a test method is valid
Proof that a piece of equipment is properly installed
Proof that a process is qualified
Proof that a product design meets the design requirements
Proof that the product meets the users needs and intended uses
Proof that the process can repeatedly produce a device that meets
design requirements
This proof can also be documented in non-protocol driven studies, i.e.,
summaries, evaluations, and assessments (SEAs) that relate to a product,
a process, a test method, a piece of software or equipment, a facility, or a
utility.
Examples of these SEAs include environmental impact
assessments, finite element analyses, tolerance stack-ups, prototype
evaluation summaries, characterization reports, design summaries, and
verification and validation summaries.
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Locating
Validation
Documents
Users with the appropriate role may locate and run system level reports
for all existing Validation Documents that they own through the Global
Toolbar My Desk menu. Other existing Validation Documents can be
located through the MVI Components Category List in an MVI, or by using
the standard search function within the ADAPTIV system.
Users with the appropriate role may also run special system reports for
Released Protocols Without Reports, and Released Protocols With Open
Action Tasks.
Role
To manage Validation Documents, you must have the role of Validation

Author in ADAPTIV. Validation Authors can create new and add existing
Validation Documents to MVIs, manage the relationship of system objects
to Validation Documents, manage the Lifecycle of Validation Documents,
and perform other Validation Document actions like editing and copying.
Types
The following Validation Document objects exist in ADAPTIV: Protocol,

Protocol Supporting Documentation (PSD), Report, Letter to File (LTF),
Summary, Evaluation, Assessment (SEA) and other Validation
Documentation.
Relationships
Validation Documents have the following relationships:

Validation Document to MVI Relationships
Protocols, SEAs and Validation Documentation are the only Validation
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DCR: 12567804 Effective: 7/29/2011
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Documents that can be created from or associated with an MVI. Protocol

Supporting Documentation (PSD), Report, and Letter to File (LTF) objects
are associated with other Validation Document objects, as described in
the next section. Although there is no limit to the number of Validation
Documents that can be related to an MVI, the recommended maximum is
about 300 Validation Documents per MVI in order to avoid impact to
system performance.
Validation Document to Validation Document Relationships
Users with the appropriate role may establish relationships for

Protocols that are not available for SEA or Validation Documentation
objects.
A one-to-many Protocol to Protocol Supporting
Documentation (PSD) relationship and a one-to-many Protocol to
Report relationship may be established.
Protocol owners may create new PSDs or add existing PSDs to
Protocols that are in the Create state. Once the relationship is
established, the Protocol follows the same lifecycle as the other
Validation Documents. The only requirement is that all PSDs must be
in the Released state before the Protocol can be promoted into the
Review state.
Users with the appropriate role may create a Report for a Protocol
once the Protocol is in the Released state.
Similar to the special Protocol relationships, a one-to-many Letter to
File to Report relationship may also be established. Users with the
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appropriate role may create a Letter to File for a Report once the
Report is in the Released state.
Validation Document to Stagegate Project Activity and DHF/Controlled
View Relationships
Validation Documents that are components of an MVI associated with

a Stagegate Project may be related to the Activities and the
DHF/Controlled View for that Stagegate Project. However, Validation
Documents cannot be related to the Project Structure or
Documentation and Tasks for a Stagegate Project.
Refer to the MD&D Adaptiv Stagegate Procedure
for more information about the use of Validation Documents
within a Stagegate Project.
Category List
All Validation Documents display the following categories in the Category

List: Properties (displayed with the object icon [
],
and the Validation Document Type: Number), File Attachments, Lifecycle,
Revisions, Where Used, References and Action Tasks.
In addition to the categories listed above, Protocols have a Reports/PSD
category and Reports have a Letter To File category in their respective
Category List.
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DCR: 12567804 Effective: 7/29/2011
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Properties
Properties (displayed with the object icon and Validation Document

Type: Number)
Attributes - Validation Documents have the following Attributes defined
on the Properties page:
Number
Title
Rev
History
Description
Owner
State
Class
Sub Class
Tertiary Class
Franchise
Operating Company
Business Unit
Site
Responsible Function
Release Date
Effective End Date
Vault
The Properties page for a Protocol also includes the following

information:
File Attachments
Reports/PSD
References
Revisions
Where Used This Revision
Action Tasks
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Actions Users with the appropriate role may perform the following
Actions from the Validation Document Properties category:
ACTION
DESCRIPTION
Edit
Edit the available Validation Document Attributes
Copy
Create a copy of the Validation Document. The

copies are placed in the same MVI as the original
Validation Document. The File Attachments and
References attached to the original Validation
Document are not transferred to the new copy of the
Validation Document.
Cancel
Cancel a Validation Document.

Cancel is an
irreversible action and can only be executed for a
document in the Create state. Once cancelled, no
further Actions or Revisions of the Validation
Document are allowed. The system prompts for a
Reason for Cancel, and then changes the Validation
Document State to Cancel.
Delete Latest Allows the user to delete the latest revision. The
Revision
latest revision can only be deleted when in the
Create State.
Lifecycle
The Lifecycle category displays the current state of the respective

Validation
Document.
STATE
DESCRIPTION
Create
The state in which the owner can perform

Actions, manage File Attachments, and add
References.
The state in which the Validation Document
can be reviewed by one or more users
Review
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DCR: 12567804 Effective: 7/29/2011
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Released
Revised
and/or groups.
has been approved and is available for use.
has been superseded by a new revision.
Refer to the MD&D ADAPTIV Validation

Document Work Instruction for details and guidance on
promoting a Validation Document from one lifecycle state
to another.
Revision
The Revision category allows users with the appropriate role to create
a new revision to any Validation Document in the Released state.
However, the system requires the user to enter a reason for revision
before it creates a new revision. The state of the new revision is
Create, the revision number is incremented by one, and the user
becomes the owner of the revision. Before the new revision is
released, the owner can delete it as long as it is still in the Create
state. When the new revision is promoted through its lifecycle to the
Released state, the system moves the previous revision to the Revised
state.
Where Used
The Where Used category displays all existing MVI Component,

Controlled View, DHF, Stagegate Project Activity, Related Validation
Document(s), and Validation Document Reference relationships for the
selected Validation Document.
Reports/PSD
(Protocols Only)
The Reports/PSD Category allows users to view all Protocol

Supporting Documentation and/or Reports that are associated with the
Protocol.
There are also actions available within the Related
Reports/Protocol Supporting Documents view. If the Protocol is in the
Create state, the available actions are: Create Protocol Supporting
Documentation, Add Existing Protocol Supporting Documentation,
Disconnect, and Delete. If the Protocol is in the Released state, the
available actions are: Create Report and Transfer This Report To Last
Rev.
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DCR: 12567804 Effective: 7/29/2011
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Letters To File
(Reports Only)
The Letters To File Category allows users to view all Letters To File
that are associated with the Report. There are also actions available
within the Letters To File view for Reports in the Released state.
These actions are: Create Letters To File and Delete.
References
Users with the appropriate role can add References to a Validation

Document. The Validation Document must be in the Create state to
add references. System objects that can be referenced by Validation
Documents include Documents, Parts (product and non-product), and
other Validation Documents. Once the Reference is established, the
reverse relationship can be seen from the Where Used category in the
Category List of the referenced Document, Part, or Validation
Document. The Reference view also contains a column, Reference
Description, which can be edited to describe the relationship between
the document and its reference.
If the Validation Document is revised, the Reference(s) remain
associated with the new revision. When a Reference is revised,
ADAPTIV associates the latest revision of the Reference with the
released revision of the Validation Document.
Action Tasks
The Action Tasks category allows users with the appropriate role to
add tasks to a Validation Document. The available list of action tasks
is predefined within the system and is the same for all Validation
Documents regardless of Type or Classification, or Franchise.
Because of the differences between Validation Documents across the
Franchises, the action task functionality will not be utilized within
ADAPTIV.
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DCR: 12567804 Effective: 7/29/2011
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Appendices
Process Flow for Validation Documents

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Cordis Franchise Method 12519156 Rev: 1

MD&D ADAPTIV Master Validation Index and Validation Document Procedure

12519156.R1_doc.pdf (1 file(s) total).

Cordis Franchise Method 12519156 Rev: 1

MD&D ADAPTIV Master Validation Index and Validation Document Procedure

12519156.R1_doc.pdf (1 file(s) total).

The purpose of this procedure is to provide an overview of Validation

Business rule for

This document must be revised and maintained in accordance with the

Refer to the MD&D ADAPTIV Glossary of Terms for information regarding

Refer to the MD&D ADAPTIV Glossary of Terms for

Cordis Franchise Method 12519156 Rev: 1

MD&D ADAPTIV Master Validation Index and Validation Document Procedure

12519156.R1_doc.pdf (1 file(s) total).

MD&D ADAPTIV Navigating Projects Work Instruction

MD&D ADAPTIV Working With Projects Work Instruction

MD&D ADAPTIV Stage Gate Procedure

MD&D ADAPTIV Master Validation Index Work Instruction

MD&D ADAPTIV Validation Document Work Instruction

MD&D ADAPTIV Basic Navigation Work Instruction

MD&D ADAPTIV Change Order Work Instruction

MD&D ADAPTIV Change Project Work Instruction

MD&D ADAPTIV Managing Project Work Instruction

MD&D ADAPTIV System Configuration Work Instruction

MD&D ADAPTIV Managing Shared P&P Procedure.

MD&D ADAPTIV Glossary of Terms

Cordis Franchise Method 12519156 Rev: 1

MD&D ADAPTIV Master Validation Index and Validation Document Procedure

12519156.R1_doc.pdf (1 file(s) total).

Cordis Franchise Method 12519156 Rev: 1

12519156.R1_doc.pdf (1 file(s) total).

MD&D ADAPTIV Master Validation Index and Validation Document Procedure

Master Validation Index (MVI)

The Master Validation Index is an ADAPTIV system object that provides a

Cordis Franchise Method 12519156 Rev: 1

MD&D ADAPTIV Master Validation Index and Validation Document Procedure

12519156.R1_doc.pdf (1 file(s) total).

When created directly from these objects, an MVI to object relationship is

Cordis Franchise Method 12519156 Rev: 1

MD&D ADAPTIV Master Validation Index and Validation Document Procedure

12519156.R1_doc.pdf (1 file(s) total).

Note: The graphics contained within this document are for

The documentation (Validation Documents) necessary to develop, study,

Cordis Franchise Method 12519156 Rev: 1

MD&D ADAPTIV Master Validation Index and Validation Document Procedure

12519156.R1_doc.pdf (1 file(s) total).

Cordis Franchise Method 12519156 Rev: 1

12519156.R1_doc.pdf (1 file(s) total).

MD&D ADAPTIV Master Validation Index and Validation Document Procedure

MVI Class: Number)

Attributes - All MVIs have the following Attributes defined on the

Edit the available MVI Attributes.

Create a copy of the MVI. All of the MVI Components

Cancel an empty MVI. The system displays an error

Search for all Validation Document types within the

Cordis Franchise Method 12519156 Rev: 1

12519156.R1_doc.pdf (1 file(s) total).

MD&D ADAPTIV Master Validation Index and Validation Document Procedure

Refer to MD&D ADAPTIV Master Validation Index

Cordis Franchise Method 12519156 Rev: 1

MD&D ADAPTIV Master Validation Index and Validation Document Procedure

12519156.R1_doc.pdf (1 file(s) total).