Expert answer:Project Design: Analyze the problem that you have
Expert answer:Below is a description of the entire project for the focus of this paper we are working on t he design portion of it, but I provided further information to help with the Project design.Project Design: Analyze the problem that you have identified and explain why the problem is significant- you will design and develop your project solution and then report on it. If you implement your solution, in your
report you should include a summary of your implementation and testing. If you are not able to implement your solution, you may develop a model, simulation,
prototype, or proof of concept as an alternative to developing a fully implemented project. In this case, in your report you should include a plan for
implementation and testing.
Your report must provide clear evidence that your project was implemented and tested (or is implementable and testable). This can be achieved by documenting a
demonstration of the project in use or documenting an explanation of the model, simulation, or prototype. Consider using video or screenshots to demonstrate
and explain your project. If the implemented project is to be supplied to the instructor, you could provide a user manual that explains how to install, configure,
and run the software. You are encouraged to submit artifacts of the project such as diagrams, software applications, database designs, and process documents.
Make sure to include clear instructions for accessing and using these artifacts. The design and development of your project solution should demonstrate
professional-level knowledge and skills.
Your project report should include at least one recommendation for future enhancements. Explain what you might add to the project if you had more resources?
What risk(s) would you need to consider before the enhancement was implemented at some future point in time? What would first have to happen before the
future enhancement was seriously considered?
it700capstoneitprojectproposal.docx
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Running head: IT PROJECT PROPOSAL FOR DATABASE MANAGEMENT SYSTEM
IT Project Proposal for Database Management System
Shakira Baez
Southern New Hampshire University
Capstone in Info Technology
IT-700-Q2183
Brian Davis, MBA, MSIM
December 09, 2017
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IT PROJECT PROPOSAL FOR DATABASE MANAGEMENT SYSTEM
IT Project Proposal for Database Management System
Problem Statement
An organization’s database is designed to meet the data needs of the organization.
Therefore, databases differ from organization to organization based on the different business
rules of each individual organization. After the acquisition of Baxalta, Shire Pharma wishes to
merge the databases of the two companies into one to ease management of the new company.
Merging the databases is a significant problem because the two companies have different
business rules therefore their data needs are different, this also translates to their database
schemas being different from each other, so it is not possible to merely copy data from the
smaller database, Baxalta, into the larger database. If not done properly, the new database may
end up not being able to support the data needs of the company and in the worst case may even
lead to significant losses in the company or even collapse of the company.
Project Overview
There is a need to form one joined database system that will incorporate a
synchronization of the business merger that Shire acquired. The new developed centralized
database will enable the smooth running of Shire daily business process as expected by
management. The purpose of the merge is to have Baxalta start working together with Shire to
achieve patient success, which will enable to organization to remain the number one
pharmaceutical specializing in rare disease, and it will allow Shire to remain profitable,
therefore, a successful merger is essential as this will form a central management point. Having
two different database systems for the same company poses a management challenge, as it can
lead to inconsistencies and loss of data integrity, therefore, to avoid such challenges a database
integration is important. The proposed project will ensure a smooth management process from a
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IT PROJECT PROPOSAL FOR DATABASE MANAGEMENT SYSTEM
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single point of view (Kaplan & Norton, 2006), which is composed of designing a new data
model for the new organization and to implement the new database design into a new physical
database which can support the data needs of the organization. After implementation of the new
database design into a physical database, the data from the two companies will then be copied
into the new one. The design of the new database will involve stakeholders from both companies
to ensure that there will be no significant data losses during the transition. As a security measure,
the transition to the new system will be incremental and in parallel with the existing system, and
it will be done in phases, as this will allow for the new technology such as cloud computing,
application program, database environment: data, hardware, software, people, and procedures
among other will be used to implement the new system. The different implementation phases
will include testing to ensure performance before the actual data and information are put in place,
which will be done on a department by department basis until the entire system has been
replaced. This exposes the system to the minimum risk of data loss.
Methodology
Currently Shire Pharma uses a distributed database system while Baxalta uses a
centralized database system. Each of the two companies oversees managing and securing their
data as well as supporting their hardware, software, and networking systems. The proposed
solution will enable the reduction of resources used to manage and keep the state of the database.
Moreover, it will help reduce the overall complexity inherent in using multiple databases at the
same time.
The plan is to use the existing infrastructure of the two companies to support the new
database that will be designed. The database design and implementation will follow the
following full lifecycle of application development:
IT PROJECT PROPOSAL FOR DATABASE MANAGEMENT SYSTEM
•
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Requirements elicitation – involve stakeholders in gathering data needs of the new
database.
•
Database design – design data model to support discovered business rules
•
Evaluating designs and selection – select the best data model
•
Logical database design
•
Physical database design
•
Implementation
•
Uploading data
•
Testing
•
Maintenance
From the above, however, it is projected that the most serious problem that could occur is
a lack of consensus on a data model to use. This is because each of the stakeholders’ opinions
may not take into consideration the overall needs of the new organization structure. To resolve
this, all consideration will go to the purchaser, which in this case is Shire, as they bought
Baxalta, therefore, they will decide which choice of a data model will to implement. The
implementation of the data model will take place during the first 3 phases.
Tools
To achieve success a wide variety of tools will be required, as the two companies already
use relational databases, thus, creating a need to employ the use of a relational database
management system. However, since the amount of data is projected to increase as well as the
demand for accessing the data, we will need a more powerful RDBMS, as this type of database
provides, relationship between tables using primary keys, foreign keys and indexes, which
reduces redundancy, its faster because of its relational model, thus the fetching and storing of
IT PROJECT PROPOSAL FOR DATABASE MANAGEMENT SYSTEM
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data become faster than the old Navigational model, making it a widely used system
by enterprises and developers for storing complex and large amount of data (Twinkle, 2012),
which is exactly what this project needs to achieve a successful migration. Copying the data into
the new system is also creating another challenge since the dataset is so large it cannot be
manually copied over. Additionally, RDBMS ensures transactional atomicity, consistency,
isolation, durability, and collectively known as the ACID, which are powerful properties of the
RDBMS, since ACID compliance guarantees that all transactions are completed correctly or that
database is returned to its previous state if a transaction fails to go through (Mullins, 2005-2017),
which is crucial tool for the project, as it will allow the transferring of data to be more successful,
and accurate. Furthermore, by utilizing RDBMS for the integration of data from Baxalta and
Shire it will enable the new system to have the most exact data, and it will reduce the possibility
of losing important information that is essential for the business to operate, as RDBMS provides
the following benefits:
(Soltesz, 2017)
•
Multi-User Access – It allows multiple database users to access a database
simultaneously with its built-in locking and transactions management functionality,
users access data as it is being changed, which prevents collisions between two users
updating the data, and keeps users from accessing partially updated records (Soltesz,
2017).
•
Privileges – Allows the database administrator to restrict access to authorized users,
and grant privileges to individual users based on the types of database tasks they need
to perform, and it defines authorization based on the remote client IP address in
IT PROJECT PROPOSAL FOR DATABASE MANAGEMENT SYSTEM
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combination with user authorization, restricting access to specific external computer
systems (Soltesz, 2017).
•
Network Access – Provides access to the database through a server daemon, a
specialized software program that listens for requests on a network, and allows
database clients to connect to and use the database (Soltesz, 2017).
•
Speed – Even though RDBMS is not the fastest data structure, it less complicated
than other database systems its optimizations built into an RDBMS design enhances
performance, allowing RDBMSs to perform more than fast enough for most
applications and data sets (Soltesz, 2017).
•
Maintenance – It provides database administrators with tools to easily maintain, test,
repair and back up the databases housed in the system (Soltesz, 2017).
•
Language – It supports Structured Query Language(SQL), which is a simple SQL
syntax, that uses standard English language keywords and phrasing, making it
intuitive and easy to learn, and it allows for non-SQL database-specific keywords to
be added to the SQL language (Soltesz, 2017).
To enable copying of the data, the IT team will use a customized Python3.5 scripts to
export the data into the new database. The choice of language was influenced by the fact that
Python is a simple scripting/programming language so development time will be shorter.
Moreover, the use of PyCharm Integrated Development Environment for Python to further help
in speeding up development time is essential, as its built-in high-level data types, its dynamic
typing, its powerful polymorphic list and dictionary types, and its syntactic support, which is
built straight into the language, will enable Shire to merge Baxalta database system with ease the
run-time (“Comparing Python to Other Languages,” 1997-2017). Additionally, Python offers
IT PROJECT PROPOSAL FOR DATABASE MANAGEMENT SYSTEM
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many features that will allow creating the new system easier, it will enable administrators to add
the tools they need more effectively, and it will allow Shire to create a system with the tools,
features, and components that incorporates the best of both Baxalta and Shire older system,
which will set the stage for a smoother transition to the new system. Some of the new tools
include:
•
With Python 3, print() is now explicitly treated as a function, so to print out the same
string above, you can do so simply and easily using the syntax of a function making
Python’s syntax more consistent and made it easier to change between different print
functions (Tagliaferri, 2016).
•
Python 3 uses Unicode by default, which saves programmers extra development time,
and it allows for administrators to easily type and display many more characters
directly into your program (Tagliaferri, 2016).
Requirements
For this proposed system to work well and deliver on its duties the database must be
online always so that the users of the system can connect to it to query and update the data.
Moreover, since users will be able to connect to the database application remotely, it is important
that the application implements security measures to prevent accidental or intentional tampering
with the data. The servers hosting the database as well as the network the servers are on, must be
powerful and have enough bandwidth to handle the projected increase in data traffic, due to
increased number of users accessing the system.
With all these requirements, it should also be noted that one of the biggest assumption of
this proposed project is that the new database design will not deviate much from the initial
databases of the two companies, hence making it possible for the existing users to migrate to the
IT PROJECT PROPOSAL FOR DATABASE MANAGEMENT SYSTEM
new database with minimal need for training. Thus, creating the need for the new system to
utilize Oracle RDBMS and its Hardware, Software, and Hard disk requirements, which are as
follows:
Hardware:
(“Oracle Database Preinstallation Requirements,” 2017)
•
Physical memory (RAM) – 256 MB minimum; 512 MB recommended
•
Virtual memory – Double the amount of RAM
•
Disk space – Basic Installation Type total: 2.04 GB
•
Video adapter
•
Processor – 550 MHz minimum
Hard Disk Space Requirements:
(“Oracle Database Preinstallation Requirements,” 2017)
•
TEMP Space – 125 MB, SYSTEM_DRIVE:Program FilesOracle – 3.1 MB, Data
files – 950 MB
Software:
(“Oracle Database Preinstallation Requirements,” 2017)
•
System Architecture – Processor: Intel (x86), AMD64, and Intel EM64T
•
Operating System – 32-bit Windows XP Professional
•
Network Protocol – TCP/IP with SSL
Compliance
Data integrity, compliance, and safety are very important components of the
pharmaceutical industry, as these components drive their ability to serve patients safely and
effectively, and they are the backbone of Current Good Manufacturing Practice (CGMP)
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IT PROJECT PROPOSAL FOR DATABASE MANAGEMENT SYSTEM
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compliance. Effectual data integrity practices are essential to the pharmaceutical industry since it
gives an increase in the attention to data integrity shortcomings by global regulatory agencies
and the possibility of a less stringent regulatory environment (Ruth, 2017).
The purpose of the regulations set forth by the FDA, which need to be obeyed by any
organization who wishes to do business with the U.S.A is to ensure for safety, identity, strength,
quality, and purity, which include executing data integrity requirements involving organizations
to implement process and procedures that will allow their data to be backup with accuracy,
preciseness, and completeness, while maintaining the data secure, inadvertent erasures, and loss
(Takahashi, 2016).
Other laws and regulations this project will need to follow include:
(Takahashi, 2016)
• CFR 212.110(b) – This requires that data be stored to prevent deterioration or loss
• CFR211.100 and 211.160 – This require that certain activities be documented at the
time of performance
• CFR 211.180 – Requires that records be kept as original records, true copies, or other
correct reproductions of the original records
• CFR 211.188, 211.194, and 212.60(g) – Demands complete information, complete
data derived, complete record of all data. Electronic signature and record-keeping
requirements are laid out in 21 CFR part 11 and apply to 60 certain records subjects
to records requirements in Agency regulations, including parts 61 210, 211, and 212
(Takahashi, 2016).
Furthermore, compliance with EMA regulations World Health Organization (WHO) Annex 5, which states that data should be complete as well as being attributable, legible,
IT PROJECT PROPOSAL FOR DATABASE MANAGEMENT SYSTEM
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contemporaneous, original, and exact (ALCOA) (“Guidance on good data and record
management practices,” 2014) will need to be implemented. While the following regulations will
also need to be considered:
(“Data Quality, Records Management & FDA Recordkeeping Laws,” n.d.)
• ICH E6 Good Clinical Practice – Biopharmaceutical standard that clarifies types of
records to retain associated with clinical trials
• ISO 15489: Records Management Standard – An international industry consensus
standard that provides a high-level framework for records retention
• GHTF SG3.N99 Quality Management Systems – Process Validation Guidance – A
harmonized medical device regulatory standard that provides suggested retention
requirements for policies, SOPs, and process validation documentation
• 36 CFR Parts 1220-1239 NARA Regulations – These regulations lay out requirements
for records and data management controls for US Federal agencies; as such they can
serve as a benchmark of minimum expectations for private industry
• Uniform Commercial Code (UCC) – Harmonizes state laws regarding business
transactions, primarily with goods and property such as sales and leases, plus
contractual agreements; sets forth minimum retention periods for receipts and other
related records
• Uniform Preservation of Private Business Records Act (UPPBRA) – Enacted by
multiple states; clarifies that business records no otherwise specified by regulation,
statute or court order may be destroyed after the expiration of three years
• Sarbanes-Oxley Act of 2002 – Requires effective internal controls over financial data,
including audits and reviews; see also 17 CFR 210 Retention of Records Relevant to
Audits and Reviews
IT PROJECT PROPOSAL FOR DATABASE MANAGEMENT SYSTEM
• Stored Wire and Electronic Communications and Transactional Records Access Lays out access and storage requirements, along with civil punishments for
destruction thereof, for records that organizations must retain
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IT PROJECT PROPOSAL FOR DATABASE MANAGEMENT SYSTEM
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References
Bwisa, H. M. (2017). The basics of writing a statement of the problem for your research
proposal. Retrieved from https://www.editage.com/insights/the-basics-of-writing-astatement-of-the-problem-for-your-research-proposal
Comparing Python to Other Languages. (1997-2017). Retrieved from
https://www.python.org/doc/essays/comparisons/
Kaplan, R. S., & Norton, D. P. (2006). How to Implement a New Strategy Without Disrupting
Your Organization. Retrieved from https://hbr.org/2006/03/how-to-implement-a-newstrategy-without-disrupting-your-organization
Mullins, C. S. (2005-2017). Evaluating the different types of DBMS products. Retrieved from
http://searchdatamanagement.techtarget.com/feature/Evaluating-the-different-types-ofDBMS-products
Oracle Database Preinstallation Requirements. (2017). Retrieved from
https://docs.oracle.com/cd/B19306_01/install.102/b14316/reqs.htm#i1005703
Ruth, A. (2017). Why Pharmaceutical Data Integrity Is More Important Than Ever. Retrieved
from https://www.pharmamanufacturing.com/articles/2017/why-pharmaceutical-dataintegrity-is-more-important-than-ever/
Soltesz, D. L. (2017). The Advantages of a Relational Database Management System. Retrieved
from https://www.techwalla.com/articles/the-advantages-of-a-relational-databasemanagement-system
Tagliaferri, L. (2016). Python 2 vs Python 3: Practical Considerations. Retrieved from
https://www.digitalocean.com/community/tutorials/python-2-vs-python-3-practicalconsiderations-2
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Takahashi, K. (2016). Data Integrity and Compliance With CGMP Guidance for Industry.
Retrieved from
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guid
ances/UCM495891.pdf
Twinkle, B. (2012). What Is DBMS? What Is RDBMS? DBMS Vs RDBMS. Retrieved from
http://www.mytecbits.com/microsoft/sql-server/what-is-dbms-what-is-rdbms
Wiegers, K., & Beatty, J. (2013). Developing Requirements for Enhancement and Replacement
Projects. Retrieved from
https://www.microsoftpressstore.com/articles/article.aspx?p=2222437
Worthen, B. (2002). Success Factors for Integrating IT Systems After a Merger. Retrieved from
https://www.cio.com/article/2440630/mergers-acquisitions/success-factors-forintegrating-it-systems-after-a-merger.html
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