This document outlines user requirements for a document management system for Health First Pharmaceutical Company's Manufacturing Division. It defines requirements for document submission, review, approval, metadata migration from current systems, and record retention. The system must support ISO and cGMP compliance. Key user types are identified along with their access levels and needs. Document library structure and metadata requirements are also specified.

1. Health First Pharmaceutical Company
Heath First Manufacturing Division
User Requirements Specification
DR & CM Consulting International
Linda Doll, Principal Consultant

2. Introduction
Purpose
• This document specifies the user requirements for a document management
solution for HFMD.
Objectives
• To define requirements for adding new or updated quality documents
to the DMS.
• To define requirements for review and approval of new or updated
quality documents.
• To define requirements for migrating metadata from current Document Control
System (DCS) into DMS.
• To define requirements for migration of metadata of documents from current file
servers and synchronizing these with metadata migrated from DCS.
• To define requirements for retention and disposal of document records.
• To assure compliance with both ISO standards and the CGMP in addition to all
other applicable U.S. Australian and international regulations.
Scope
The scope of this project is to define the user requirements specifications for the
implementation of an IDCM system with intranet capabilities, the preferred option as
defined in the Feasibility Study. For further details, please see the reports listed in
References.
• Requirement for an integrative DR&CM solution for managing quality
documents.
• Requirement for the migration of data from the DCS and the migration of
documents from the network file system.

3. • Requirements for registration of hardcopy documents that the business deems
relevant to maintain.
• Business stakeholders will nominate representatives to clean up quality
documents prior to migration to the new system.
• Requirements for engineering drawings are not included in this specification as
they were excluded from the scope of this project in the PID.
• Requirements for corporate policy documents are not included in this
specification as they were excluded from the scope of this project in the PID.
Approach
The project approach for this User Requirements Specification will be to:
• Review the approved Project Initiation Document and Feasibility Study report
documentation.
• Meet with key stakeholders to ascertain requirements specific to their functions
and perceived needs.
References
Doll, Linda. Feasibility Study. Version 1.0, May 28, 2008.
Doll, Linda. Project Initiation Document. Version 1.0, May 5, 2008.
Health First Manufacturing Division. Terms of Requirement. Version 1.0, January 7,
2008.
Acknowledgements
DR & CM Consulting International wishes to acknowledge the cooperation of the
stakeholders of HFMD; their honesty and cooperation have made these recommendations
more accurate and responsive.

4. Business Environment
The record growth of HFPC, coupled with expansion into previously untapped markets,
have combined to put strain on procedures and systems, once deemed adequate, that are
perceived as no longer efficiently supporting business objectives, operations and
processes. The requirement to pass an ISO audit was the initial impetus for the current
project.
Please reference the Feasibility Study, the Project Initiation Document or the Terms of
Requirements as listed in the Reference Section.
User & Document Definitions
User Type Definitions:
The scope of the user base will consist of the management and employees of HFMD, to
include but not to be limited to:
 Plant manager
 Shift supervisors
 Pharmacists
 Quality Control Manager
 Quality Control Personnel
 Formulation Personnel
 Work Center users

5. User Profile
Functionality Number Profile
Title/User role User Type
Required of users Type
Create and save
documents; view and
Operating
Plant Manager Contributor/Creator print documents; 1
System
participate in
document workflow.
Create and save
documents; view and
Shift Operating
Contributor/Creator print documents; 3
Supervisors System
participate in
document workflow.
Create and save
documents; view and
Operating
Pharmacists Contributor/Creator print documents; 4
System
participate in
document workflow.
Create and save
Quality Control documents; view and
Operating
Contributor/Creator print documents; 1
Manager System
participate in
document workflow.
Create and save
documents; view and
Quality Control Operating
Contributor/Creator print documents; 5
personnel System
participate in
document workflow.
Formulation Consumers Access and view 79 Web
personnel/ standard operation Browser
procedures and
Work center operating
instructions.

6. users
Document Library / Folder Type Definitions
The Document Library will consist of Folders and Files. Folders will consist of groups of
documents and files will consist of individual documents with a unique number generated by the
File Classification Scheme, to identify that document alone.
The Document Library will be searchable according to Metadata Types:
• File Number
• File Type
• File Description
• Current Status
• Location
• Disposal
• Action Officer
• Subject
• Document Type (letter, memo, contract, etc.)
Metadata is to be assigned at the Folder level; all documents in a Folder will inherit the Metadata
associated with that Folder.
The Folders will consist of:
• Quality Systems /Manual

7. • System Management Procedures
• Standard Operating Procedures
• Operating Instructions
• Methods
o Test Methods
o Analytical Methods
o Microbiological Methods
• Raw Materials
• Finished Products
• Position Descriptions
• Forms
• Registers, Logs, Lists
• Drawing Office and Technical Library

8. Document Type Definitions
Document Profile
Document Types Prefix Retention (Years)
Quality System/Manual QM 10
System Management Procedures SMP 10
Standard Operating Procedures SOP 10
Operating Instructions OI 10
Test Methods 10
Raw Materials RMQS
Finished Products PQS
Analytical Methods AM
Microbiological Methods MM
Position Descriptions PD 1
Forms FOR 1
Registers, Logs, Lists REG 1
Drawing Office & Technical Library 10

9. Desktop Authoring Tools
• The Desktop Authoring Tool specified will be Microsoft Word 2003.
• Formats supported will be Native Format and Standard Rendition Format.
• The filename extensions will be:
Filename
Contents
Extensions
.doc Word processing files
.jpg Graphics files
.xls Spread sheet files
.pdf Portable document format files
.xml Files written in Extensible Markup Language
.ppt PowerPoint presentation files
.avi Video files
• The HFMD requirement is for documents to be stored in their native desktop
application formats with renditions publishable to PDF and JPG formats.
• Certain filename extensions will be disallowed, i.e. .mp3 files. Override of this
provision will be at the discretion of someone with management level clearance,
such as the Plant Manager.

10. Functions and Processes
Document Capture
Users must be able to:
• Create a new blank document and save it as a new document into the IDCM.
• Reuse an electronic document and save it as a new document into the IDCM.
• Scan documents to image format.
• The IDCM system should provide the capability to integrate with templates
created by authoring applications, to enable users to capture key information
relating to template-initiated documents, such as reports, memoranda, minutes,
agendas, letters and specifications.
• Where a template is available, the Microsoft Office should invoke the template
from the IDCM system. The storage of templates in the repository will provide a
managed environment for templates, so that the correct version of the template
will be presented when invoked at the desktop.
• The IDCM system must allow users to save electronic documents into its
repository from within Microsoft Office 2003. The integration of a DMS with
office productivity suites must be transparent to the user during the capture
process.
• The IDCM system will also be required to provide the capability to capture types
of electronic document formats other than those from office applications,
including images from workgroup level document imaging applications.

11. • The save regime within the IDCM system should enable users to save documents
to external stores such as network file systems, local hard drives, diskette, or CD-
RW. The system is required to default to “save to the IDCM”.
• The IDCM system must be able to record consistent metadata about a document
to facilitate its retrieval. The system should automatically collect as much
metadata as possible from the user’s system environment; essential data should be
validated before being stored in the IDCM database, using techniques such as
mandatory fields, controlled lists, and default settings based on document or user
profiles.
Version Control
• There is a requirement for the system to default to minor version numbering (0.1,
0.2, etc.) for all new or updated documents added to the system.
• There is a requirement to give the user the option to select a major version
number (1.0, 2.0, etc.) for a document to override the default minor version.
• There is a requirement for the version control system to support major numbering
for published versions of the document when authorized by the integrated
workflow.
The user will have two versions available online; the current version, and the one
previous to the current version. All other versions will be archived in secondary storage.
Rendition Management
• When a new version of an editable document has been captured, the system will
render the Word, Excel or PowerPoint document to PDF format and assign the

12. Document ID, relevant version number as metadata: the previous rendition will be
archived.
• Only the new rendition will be available to system users; higher clearances will be
required to access older renditions in the archives.
Workflow
With the IDCM system, document workflow will be electronic.
• Creators/Authors will generate new documents, or amend existing documents.
They will then store the original document in the IDCM database, and circulate
links to renditions to multiple reviewers for approval.
One or all reviewers can reject the new documents/amended document.
• If a reviewer rejects the document, the workflow will direct a workflow task with
link to the rendition back to the creator/author with markup comments. The
Document Status will change back to “Draft”.
All reviewers must endorse the document before it is sent for approval by an approver
and an approver can reject the new document/amended document. If an approver rejects
the document, then the Document Status will change back to “Draft”.
• If an approver rejects the document, the workflow is required to route a workflow
task with a link to the document back to the creator/author, with markup
comments, for further revision.
• When approved by an approver, the Document Status will be changed to
“Approved”.
• The approved document will be branded with a new minor version number; the
previous version will be archived.
The approved version will then be rendered to PDF for publication on the HF Intranet.
• Rendered versions of approved documents will be published to the Intranet, for
viewing and utilization by employees with the appropriate clearances.

13. When it is published, the Document Status will change to “Published”.
• The employees will be able to utilize the IDCM database to search retrieve view
and print the published rendition.
Document Lifecycles
Action Document Status
Document created/amended. Draft
Document circulated among approvers. For Approval
Document rejected by one or more approvers. Draft
Document accepted by approvers. Approved
Document accepted for publication. Published
Default security profiles are assigned to each version of a document, enabling restrictions on user
access, i.e., they are only able to see the current (or specified earlier).
Search and Retrieval
Information retrieval-search functionality:
• Search on metadata (e.g. action officer, subject, etc.) and words in the actual
content of the document form a single entry point.
• Search on metadata relevant to a specific document class, e.g., memo, report, etc.
• “Boolean operators” (and, or, not) are provided for combining metadata fields I
complex searching.
• “Boolean” to be used to formulate searches against full-text indices. The type of
operators allowed will be AND and OR.

14. • Phrase (explicit or implied) and proximity searching is based upon locations in
index files.
• Ability to retain interim search sets during a search is available, so that they may
be recombined in different ways.
• Statistical and word frequency search techniques use semantic and fuzzy logic
techniques to improve search performance and reduce complexity of search
constructs.
• Search of multiple folders or restricted to specific folders, document types or
other groupings based on document location or owner is possible.
• Browse multiple folders or a specific folder.
• Search results may be filtered in order to increase precision.
• Search results may be ranked in order or perceived relevance.
• Search queries are saved for reuse.
• Search queries are saved at facility and workgroup hierarchical levels.
• Document or set of documents may be selected as being representative of relevant
documents and then search and retrieve can be invoked for “like” documents.
• Integrated thesaurus capability of research is available
• All current version text based documents will be full text indexed.
• Metadata search will be available, in addition to the generic search capabilities
provided by a document management system.
Viewing /Printing Documents

15. Viewing documents
• Viewer enables (relevant) documents to be displayed without loading the native
authoring tool
• Viewer supports multiple formats.
• Launch reader for viewing PDF files.
• Viewer supports annotation tools to enable document reviewers to mark-up
changes to documents.
• Annotations are managed as a separate object to the associated document.
• Checkout the native document from the viewing tool.
Printing Documents
Consider the applicability and relevance of the following functionality
• Digital documents of standard size (e.g. letter 8.5x11 inches or A$, depending on
local requirements) printed from IDCM to networked laser printers
• Digital documents of larger size (e.g. size B or A3) on existing networked laser
printers that support such types of trays
• All quality documents printed will display a banner across the top of the page,
stating, “This document is out of date as of the date of the printing.”, and advising
that in order to insure that they have the latest version of a quality document, they
should request of the IDCM system a new printout. A banner across the bottom
of every page should read “Please destroy this copy after use.”

16. System Interfaces
The IDCM system should be fully compatible with the Health First Intranet.
Security Requirements
Only the original author will have the ability to edit a document. All other personnel will
mark up a copy, to be routed back to the author for consideration.
Retention and Disposal
The originals of all quality documents migrated into the IDCM will be archived, pending
confirmation by trained personnel of the accuracy of the copies found in the IDCM
system. The records will then be retained for 10 years.
System Changeover/Data Migration Requirements
Due to the relatively small number of relevant quality documents, the documents will be
hand keyed into the IDCM system. The documents will include metadata to match that
captured automatically by the IDCM system, to facilitate search capabilities.
Backfile Conversion
There will be minimal Backfile conversion.

17. • Existing hardcopy quality documents will be assessed by the business
stakeholders. Those that are deemed still relevant will be manually entered into
the IDCM system. Hardcopies will be retained in archives for 5 years.
• Business stakeholders will nominate representatives to clean up quality
documents prior to migration to the new system.
• Scan resolution to be determined by test scans before imaging.
• Scans will be bi-tonal except where there are embedded diagrams, in which case
grayscale or color imaging may need to be supported.
• Scanned files will be saved to PDF.
• Physical copies will be saved and stored offsite for 10 years.
Change Management
Training in the use of the new system will be the responsibility of the IT department, with
assistance from the staff of DR & CM International consultants.
Functionality Creator/Contributor Collaborator Consumer
Create new document Yes No No
Edit a document Yes No No
Route/Workflow
Yes No No
document
View Yes Yes Yes
Print Yes Yes Yes
Search/Retrieve Yes Yes Yes