1. Health First Pharmaceutical Company
Health First Manufacturing Division
Implementation Strategy
DR & CM Consulting International
Linda Doll, Principal Consultant
2. Introduction
This is the fourth deliverable in a series commissioned by Health First Manufacturing
Division, a wholly owned subsidiary of Health First Pharmaceuticals. The previous
deliverables are listed in the Reference section.
Purpose
The purpose of this deliverable is to assess the implementation options and to arrive at a
recommendation for a preferred option.
References
Doll, Linda. User Requirements Specification. Version 1.0, June 4, 2008
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.
Glossary
o DCS/Document Control System
o HFMD/ Health First Manufacturing Division, Sydney, Australia.
o HFPC/Health First Pharmaceutical Company.
o IDCM/ Integrative Document and Content Management.
3. Implementation Options
The implementation of a system for managing quality documents within HFMD is defined as an
“application specific” solution, which is tailored to meet a specific business requirement, rather
than a general or enterprise level application of document management within the organization.
Due to the risks with the current system and the imperative of a successful ISO audit, the
implementation options to be considered include:
o Option 1: Direct cutover after data/document migration with progressive backfile
conversion of hardcopy documents.
o Option 2: Direct cutover after data/document migration with full backfile conversion of
hardcopy documents
o Option 3: Parallel operations- go live with new system with progressive data/document
migration and progressive backfile conversion.
o Option 4: Agile methodology- a planned staged release of functionality, within a
roadmap and progressive backfile conversion.
Preferred Option
The preferred option is either Option 1 or a combination of Option 1 and Option 4.
Option 1 will get the system operational with the data and documents migrated into it and to
meet the challenge of the ISO imperative. It then allows the hardcopy documents to be
progressively scanned into the system.
Option 2 includes the hardcopies being converted to digital image; this is not a mandatory pre-
requisite to meet the ISO requirement. The Option is therefore not recommended.
4. Option 3 has the risk that the existing digital documents are not migrated to the system in
sufficient time to satisfy the ISO audit. It also means keeping two systems going, and since it is
known that the original system is deficient, that would make this option unacceptable.
Option 4 is a progressive release of functionality following a roadmap. There is the requirement
of understanding what functionality is being delivered in incremental releases, which would be
specified in the roadmap attached to the option. It also has to be sufficient to meet the ISO
requirements.
The Application Specific solution will address the immediate need of the problem of quality
documents. Agile Methodology will be used to define and deploy functionality. The Combined
Option should address the shortcomings in the management of quality documents immediately,
with improved scalability, flexibility, extensibility, security and performance to be had upon full
implementation of the roadmap.
Conclusion
The Implementation Strategy has examined implementation options for an effective solution for
managing HFMD’s quality documents. Four implementation options were considered and it is
recommended that the Project Board approve Option 1 or a combination of Options 1 and 4,
which is the preferred option based on the Implementation Strategy Report.
Acknowledgements
The DR & CM Consulting International wishes to acknowledge the cooperation of the
stakeholders of HFMD; their cooperation and insights have made these recommendations more
accurate and responsive.
Appendix
5. The following tables explain the advantages and disadvantages of each option more clearly. Any
questions can be referred to the lead consultant of DR & CM Consulting International.
6. Option1: Direct cutover after data/document migration with progressive backfile conversion of hardcopy documents.
Factor Risk Assessment Observations
Business LOW The risk to the business is considered LOW because:
• The solution is tailored to the business requirements for managing quality documents in HFMD.
• All new and legacy digital quality documents will be stored in the one repository to support ISO audit.
• There is no imperative to have hardcopy documents scanned prior to system deployment. (The hardcopies
will still be available if required, during progressive backfile conversion).
Technology MEDIUM The technology risk is considered MEDIUM:
• It is HFMD’s first deployment of a DMS with integrated workflow.
• There is no requirement to support distributed sites or an enterprise deployment.
• Reduces the impact of change on the IT environment.
• Allows IT to become proficient with technology and with its adaptation to the business requirement.
• Allows IT to build support for the solution and also to learn how the solution supports the business function.
Financial MEDIUM The financial risk is considered MEDIUM:
• The system is implemented across HFMD during direct cutover. Investment in licenses will be required for
all HFDM users.
• Licensing costs cannot be staged.
• Hardware and infrastructure costs cannot be staged.
• Maintenance and support costs cannot be staged.
• Backfile scanning may lose imperative with potential impact on costs.
7. Option 2: Direct cutover after data/document migration with full backfile conversion of hardcopy documents.
Factor Risk Assessment Observations
Business MEDIUM/ HIGH The risk to the business is considered MEDIUM to HIGH because:
• The requirement to undertake the backfile conversion before the system goes live.
• The solution is tailored to the business requirements for managing quality documents in HFMD.
• All new and legacy digital quality documents will be stored in the one repository to support ISO audit.
Technology MEDIUM The technology risk is considered MEDIUM because:
• The data conversion may only require a workgroup scanning solution (not a production system).
• The scanning may be outsourced.
• Allows IT to become proficient with technology and with its adaptation to the business requirement.
• Allows IT to build support for the solution and also to learn how the solution supports the business function.
Financial MEDIUM/HIGH The financial risk is considered MEDIUM to HIGH because:
• The need for the project to manage (in-house or outsourced) scanning of backfile documents in sufficient
time to meet project imperatives, which could be costly.
8. Option 3: Parallel operations- go live with new system with progressive data/document migration and progressive backfile conversion.
Factor Risk Assessment Observations
Business MEDIUM/HIGH The risk to the business is considered MEDIUM to HIGH because:
• The progressive migration of data/documents means that users have to search and retrieve documents from
two systems until the migration is completed.
• There is the risk that the users may revert to the old system (as it is known to them) rather than adopt the
new system.
Technology MEDIUM The technology risk is considered MEDIUM because:
• Although the prospect of running two separate systems concurrently is cumbersome, it does have the merit
of redundancy.
Financial MEDIUM/HIGH The financial risk is considered MEDIUM to HIGH because:
• Because this option entails running two separate systems concurrently, this qualifies as the costliest option
under consideration.
9. Option 4: Agile Methodology- a planned staged release of functionality, with a roadmap and progressive backfile conversion.
Factor Risk Assessment Observations
Business LOW/MEDIUM The risk to the business is considered LOW to MEDIUM because:
• Agile methodology has a high likelihood of delivering the minimal set of functionality with the required
timeframe to support ISO audit.
• The business has little experience with Agile projects which represents a risk.
Technology MEDIUM/HIGH The technology risk is considered MEDIUM to HIGH because:
• IT does not have experience in managing projects using Agile methodology.
Financial MEDIUM/HIGH The financial risk is considered MEDIUM/HIGH because:
• Agile methodology features incremental releases of functionality.
• The level of effort for some items of functionality may not be able to be costed until specifications for a
release are complete, thus impacting forward cost analysis for the project.
10. Option 4: Agile Methodology- a planned staged release of functionality, with a roadmap and progressive backfile conversion.
Factor Risk Assessment Observations
Business LOW/MEDIUM The risk to the business is considered LOW to MEDIUM because:
• Agile methodology has a high likelihood of delivering the minimal set of functionality with the required
timeframe to support ISO audit.
• The business has little experience with Agile projects which represents a risk.
Technology MEDIUM/HIGH The technology risk is considered MEDIUM to HIGH because:
• IT does not have experience in managing projects using Agile methodology.
Financial MEDIUM/HIGH The financial risk is considered MEDIUM/HIGH because:
• Agile methodology features incremental releases of functionality.
• The level of effort for some items of functionality may not be able to be costed until specifications for a
release are complete, thus impacting forward cost analysis for the project.