Jett D C P: Procedure Ocument Ontrol Rocedure

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DOCUMENT CONTROL Doc ID:

JETT PROCEDURE 365886047.doc
January 2006
DOCUMENT CONTROL PROCEDURE
JOINT EQUIPMENT TRANSITION TEAM

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January 2006
Table of Contents
1.0 INTRODUCTION................................................................................................3
2.0 OVERVIEW........................................................................................................3
3.0 RESPONSIBILITIES.........................................................................................3
4.0 REQUIREMENTS.............................................................................................7
5.0 References...........................................................................................................12
REVISION HISTORY
Rev. Date Approval Revision Summary

0 1/11/02 BAL First Issue
1 2/05/02 BAL Added change control chart
2 23MAR02 BAL Removed section 4.3, changed revision letters to
uppercase, added sections 3.7.5 and 4.3.2
3 25JUL02 MTF Revised the overall setup of the Section 4. Added
additional information on naming files and the
version assignment process. Added section 4.6
Document Development Flow Diagram. Re-titled
the document as a Procedure (Originally called a
Specification).
4 22NOV02 MTF Revised section 4.6 Document Development Flow
Diagram to ensure that the document owner/sponsor
is aware that they are responsible for bumping
revisions. Also, added responsibilities to the
document sponsor role (3.2.5 and 3.2.6). Added
description for the website administrator (3.8).
5 22Jan06 JETT JAN Changed terminology where used from
Meeting pharmaceutical industry to healthcare industries.
(Remainder of Page Intentionally Left Blank)

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January 2006
1.0 INTRODUCTION
1.1 The JETT Consortium was established to improve the documentation
delivered by equipment manufacturers and provide a common technical
language base that will be widely accepted by the healthcare industries.
To that end, JETT is developing document templates to be shared with the
healthcare industries with goal of streamlining time-to-market projects.
2.0 OVERVIEW
2.1 This document defines the responsibilities and methods for preparation,
revision, control, and release of all documents created by JETT.
2.2 This procedure covers all documents produced by JETT.
3.0 RESPONSIBILITIES
3.1 Every member of the JETT Consortium, both active and associate, play an
important role in the development of quality documents. Those roles may
include:
Document Sponsor
Template Developer
Content Reviewer
Validation and GAMP4 Reviewer
Format Reviewer
Document Administrator
Website Administrator
3.2 Document Sponsor
3.2.1 A document sponsor must be a current Active member.
3.2.2 In the event a document sponsor loses Active

membership status prior to the release of a document, a new
document sponsor will be assigned from the current role of Active
members.
3.2.3 The document sponsor is responsible for moving the

document through the process from development through to
release.

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January 2006
3.2.4 The document sponsor is responsible for incorporating

comments into the document throughout the review period until
release.
3.2.5 The document sponsor will update the revision number

on the document throughout the review process.
3.2.6 The document sponsor will forward all revisions of the

document on to the document administrator for storage.
3.2.7 The document sponsor will notify the document

administrator when the draft document is ready for draft release on
the JETT website.
3.2.8 The document sponsor will pass ownership of the

document on to a committee chairperson responsible for that type
of document.
3.3 Document Developer
3.3.1 A document developer can be anyone with interest and

content expertise in the subject of the document.
3.3.2 The document developer will utilize the current, released

JETT template as a basis for the new document.
3.4 Content Reviewer
3.4.1 A document content reviewer must be a current Active or

Associate member.
3.4.2 Each document must be reviewed by a minimum of three

content reviewers.
3.4.3 The content reviewer shall have some knowledge of the

subject matter.
3.4.4 Content reviewers provide comments to the document

sponsor, to make the requested changes to the document.
3.5 Validation and GAMP Review
3.5.1 A validation and GAMP reviewer must be an Active

member of JETT.

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January 2006
3.5.2 The validation and GAMP reviewer will review the

document for coherence to industry practice/FDA expectation, the
Equipment Validation Plan and current GAMP guidelines.
3.5.3 The validation and GAMP reviewer will provide any

comments to the document sponsor to make the requested changes
to the document.
3.6 Format Reviewer
3.6.1 The format reviewer must be an Active or Associate

member.
3.6.2 The format reviewer will review the document for

coherence to the approved template format.
3.6.3 The format reviewer will make the required changes to

the document.
3.6.4 The format reviewer will change the revision level to 0, if

for initial release or increment the revision number if the document
is a revision of a previous released template.
3.6.5 The format reviewer will provide the document sponsor

with the current revision of the document and release the document
to the document administrator.
3.7 Document Administrator
3.7.1 The document administrator must be a current Active

member.
3.7.2 The document administrator will maintain all revisions of

documents.
3.7.3 The document administrator will forward draft

documents on to the website administrator upon notification from
the document sponsor that the draft document is ready for draft
release.
3.7.4 The document administrator will forward the document

on to the validation/GAMP reviewer upon notification from the
document sponsor that the document is ready for validation/GAMP
review.

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January 2006

on to the format reviewer upon notification from the document
sponsor that the document is ready for format review.

on to the website administrator upon notification from the format
reviewer that the document is ready for release.
3.7.7 The document administrator will notify committee

chairpersons upon the new release or re-release of documents.
3.7.8 The document administrator will provide adequate

backup to prevent loss of documents.
3.7.9 The document administrator will maintain the overall

JETT document index / status register.
3.8 Website Administrator
3.8.1 The website administrator must be a current Active

member.
3.8.2 The website administrator will maintain all information

presented on the JETT website.
3.8.3 The website administrator will post draft documents on

the website upon notification from the document administrator that
the document is ready for draft release.
3.8.4 The website administrator will post released documents

on the website upon notification from the document administrator
that the document is ready for official release.
(Reminder of Page Intentionally Left Blank)

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January 2006
4.0 REQUIREMENTS
4.1 Common elements used in the documentation naming convention
4.1.1 <Equipment Type> is the name of equipment.
4.1.1.1. The first letter of the word for the Equipment Type in
the document title is capitalized. All other letters in the
word are lower case.
Example An autoclave would be stated as

Autoclave.
4.1.1.2. The first letter of each word for the Equipment Type in
the document title is capitalized for equipment with
multiple words in the title. All other letters in the words
are lower case. Spaces are inserted between words.
Example A pure steam generator would be stated

as Pure Steam Generator.
4.1.2 <NNN> is an acronym for the type of document
4.1.2.1. DS Design Specification
4.1.2.2. EVP Equipment Validation Plan
4.1.2.3. FRS Functional Requirement Specification
4.1.2.4. FAT Factory Acceptance Test
4.1.2.5. HDS Hardware Design Specification
4.1.2.6. URS User Requirement Specification
4.1.2.7. QPP Quality and Project Plan
4.1.2.8. SDS Software Design Specification
4.1.2.9. The letters used for the acronym in the document title
are all capitalized.
4.1.3 <rev#> is the revision level of the document

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January 2006
4.1.3.1. Content Review is A1, A2, A3An (where n is the

current content review revision number)
The original draft of the document is assigned the

revision number A1.
Each revision during content review of the

document is assigned the next sequential content
review number.
4.1.3.2. Validation Review is B1, B2, B3Bn (where n is the

current validation review revision number)
The original validation review of the document is

assigned the revision number B1. This revision
number is assigned to the document prior to being
sent to the designated validation reviewer.
Each revision during validation review of the

document is assigned the next sequential validation
review revision number.
4.1.3.3. Format Review is C1, C2, C3Cn (where n is the

current format review revision number)
The original format review of the document is

assigned the revision number C1. This revision
number is assigned to the document prior to being
sent to the designated format reviewer.
Each revision during format review of the document

is assigned the next sequential format review
revision number.
4.1.3.4. Formal Release is 0, 1, 2n (where n is the current

released revision number)
The original formal release of the document for use

on the JETT website is assigned the revision
number 0.
Revision of the document resulting from user input

is assigned the next sequential number.

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January 2006
Revisions to documents must follow the document

change control procedure (Refer to the Document
Change Control section).
4.1.3.5. The letters used for the revision level in the document
title are capitalized.
4.1.4 <YYYYMMDD> is the release date of the document
4.1.4.1. The date is listed as current year (four digits), month

(two digits), and day (two digits).
Example May 6th, 2002 would be stated as

20020506.
4.2 Documentation naming convention
4.2.1 Equipment specific templates

<Equipment Type>_<NNN>_<rev#>.doc
4.2.2 General Templates:
Template_<NNN>_<rev#>.doc
4.2.3 Meeting minutes:
JETT_Minutes_<YYYYMMDD>.doc
4.2.4 Presentations:
JETT_Presentation_<YYYYMMDD>.doc
JETT_Presentation_<YYYYMMDD>.ppt
4.3 Documents should be created in Microsoft Office 2000 (Word, Power

Point, etc.) Format.
4.4 Document Formal Release
4.4.1 A document is defined as being formally released when it

has completed the following process:
Content review completed
Validation and GAMP review completed
Format review completed

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January 2006
Document turned over to the document administrator for storage

in the current release document folder
Document made available on the website.
4.4.2 All changes to documents formally released must follow

the document change control procedure (Refer to the Document
Change Control section 4.7).
4.5 Storage and backup
4.5.1 Covered under a separate document
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January 2006
4.6 Document Development Flow Diagram
Proposed Template
Review
REJECT
Proposed
Template(s) at No Action Taken
Monthly JETT
Meeting
ACCEPT
Assign
Sponsor
Email Document Storage to obtain

current revision of blank template
Create Draft of the
or obtain from the JETT website, if Document -
a template is available Revision A1
Document Sponsor Notifies JETT Document Sponsor Responsible for Revision of

member (active) that document will the Document to Address Comments/Concerns
be available for review at next
monthly meeting - If document is
revised, review may not be Each revision during content review of the
required Sponsor Provides
document is assigned the next sequential
Copy of Document to
number by the document sponsor
Document Storage
(A2, A3, A4...An)
Modifications
Review in breakout group at a

Required
Review of
JETT monthly meeting - If
Document
document is revised, a review
Content
session may not be required
APPROVE
Sponsor Assigns Revision B1 to

document for Validation Review.
Sponsor Provides Copy of
Document to Document Storage.

Document to Document
Storage
Modifications
Required
Validation Document Sponsor Responsible for Revision

Review of of the Document to Address Validation Each revision during content review of the
Document Review Comments/Concerns document is assigned the next sequential
number by the document sponsor
(B2, B3, B4...Bn)
APPROVE
Sponsor Assigns Revision C1 to

document for Format Review.
Format Reviewer Provides

Copy of Document to
Document Storage
Modifications
Required
Format Format Reviewer Responsible for Revision of

Review of the Document to Address Format Review Each revision during content review of the
Document Comments/Concerns document is assigned the next sequential
number by the format reviewer
(C2, C3, C4...Cn)
APPROVE
Format Reviewer Assign sRevision

0 to document for Release
Format Reviewer Provides Copy of
Updated Document on Monthly Update

the Website at JETT Meeting

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January 2006
4.7 Document Change Control Flow Diagram

Notify Doc. System Owner - Review must be Proposed Change from
Proposed Change from performed by a minimum of 2 JETT members Non-JETT Member (i.e.
JETT Member (active or assoc.) from appropriate committee website)
and assign sponsor for changes
Track all
comments on
the website
REJECT
REJECT
Review Review Proposed
No Action
Proposed Change(s) at Monthly
Taken JETT Meeting
Change
APPROVE
APPROVE
Obtain Archived Appropriate Document

Obtain current revision
Copy of the Committee Assigns
from document storage
Document Sponsor for Changes
Sponsor assigns the next

sequential revision number to the
document and modifies the
document
Notify Doc. System Owner - Review must be performed by a minimum
of 2 JETT members (active or assoc.) from appropriate committee
REJECT
Review Sponsor Responsible for Revision

Modifications to of the Document to Address
Document Review Comments/Concerns
APPROVE
APPROVE
REJECT
Sponsor Provides Copy

Review
of Document to
Corrections
Document Storage
Notify Doc. System Owner - Review must be

performed by a minimum of 2 JETT members
Updated
(active or assoc.) from appropriate committee
Document
on the Website
Monthly Update
at JETT Meeting
5.0 REFERENCES
5.1 Storage and Backup Procedure
END OF PROCEDURE

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Page 1 of 12

DOCUMENT CONTROL Doc ID:

DOCUMENT CONTROL PROCEDURE

JOINT EQUIPMENT TRANSITION TEAM

Rev. Date Approval Revision Summary

(Remainder of Page Intentionally Left Blank)

JOINT EQUIPMENT TRANSITION TEAM

2.2 This procedure covers all documents produced by JETT.

3.2 Document Sponsor

3.2.1 A document sponsor must be a current Active member.

3.2.2 In the event a document sponsor loses Active

3.2.3 The document sponsor is responsible for moving the

JOINT EQUIPMENT TRANSITION TEAM

3.2.4 The document sponsor is responsible for incorporating

3.2.5 The document sponsor will update the revision number

3.2.6 The document sponsor will forward all revisions of the

3.2.7 The document sponsor will notify the document

3.2.8 The document sponsor will pass ownership of the

3.3 Document Developer

3.3.1 A document developer can be anyone with interest and

3.3.2 The document developer will utilize the current, released

3.4 Content Reviewer

3.4.1 A document content reviewer must be a current Active or

3.4.2 Each document must be reviewed by a minimum of three

3.4.3 The content reviewer shall have some knowledge of the

3.4.4 Content reviewers provide comments to the document

3.5 Validation and GAMP Review

3.5.1 A validation and GAMP reviewer must be an Active

JOINT EQUIPMENT TRANSITION TEAM

3.5.2 The validation and GAMP reviewer will review the

3.5.3 The validation and GAMP reviewer will provide any

3.6 Format Reviewer

3.6.1 The format reviewer must be an Active or Associate

3.6.2 The format reviewer will review the document for

3.6.3 The format reviewer will make the required changes to

3.6.4 The format reviewer will change the revision level to 0, if

3.6.5 The format reviewer will provide the document sponsor

3.7 Document Administrator

3.7.1 The document administrator must be a current Active

3.7.2 The document administrator will maintain all revisions of

3.7.3 The document administrator will forward draft

3.7.4 The document administrator will forward the document

JOINT EQUIPMENT TRANSITION TEAM

3.7.5 The document administrator will forward the document

3.7.6 The document administrator will forward the document

3.7.7 The document administrator will notify committee

3.7.8 The document administrator will provide adequate

3.7.9 The document administrator will maintain the overall

3.8 Website Administrator

3.8.1 The website administrator must be a current Active

3.8.2 The website administrator will maintain all information

3.8.3 The website administrator will post draft documents on

3.8.4 The website administrator will post released documents

(Reminder of Page Intentionally Left Blank)

JOINT EQUIPMENT TRANSITION TEAM

4.1.1 <Equipment Type> is the name of equipment.

Example An autoclave would be stated as

Example A pure steam generator would be stated

4.1.2 <NNN> is an acronym for the type of document

4.1.2.1. DS Design Specification

4.1.2.2. EVP Equipment Validation Plan

4.1.2.3. FRS Functional Requirement Specification

4.1.2.4. FAT Factory Acceptance Test