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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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Page 2 of 20
Purpose
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.
Definitions,
Acronyms,
Abbreviations
Roles and
Responsibiliti
es
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Page 3 of 20
References
Document
Number
Document Name
The following documents either support this procedure and/or are referenced in this
procedure:
12520652
12519120
12519122
12519157
12520677
12519173
12519126
12520689
12520651
12519179
12574520
12519172
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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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Page 5 of 20
Overview
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.
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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Page 7 of 20
Project MVI
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Page 8 of 20
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 (
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
Copy
Lifecycle
Cancel
Search
Within
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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Page 10 of 20
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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Page 11 of 20
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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Page 12 of 20
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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Page 13 of 20
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
Types
Relationships
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Page 14 of 20
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Page 15 of 20
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
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Properties
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
Reports/PSD
References
Revisions
Action Tasks
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Page 17 of 20
Actions Users with the appropriate role may perform the following
Actions from the Validation Document Properties category:
ACTION
DESCRIPTION
Edit
Copy
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
STATE
DESCRIPTION
Create
Review
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Page 18 of 20
Released
Revised
and/or groups.
The state in which the Validation Document
has been approved and is available for use.
The state in which the Validation Document
has been superseded by a new 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
Reports/PSD
(Protocols Only)
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Page 19 of 20
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
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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Page 20 of 20
Appendices
Process Flow for Validation Documents