Miranda, Marvin John R. Salta, Aldous Management Information System October 13, 2007
Miranda, Marvin John R. Salta, Aldous Management Information System October 13, 2007
Miranda, Marvin John R. Salta, Aldous Management Information System October 13, 2007
R. Information System
Salta, Aldous
56017 Document Management Rating:
System
The tools you use for document management should be flexible, allowing
you to tightly control documents’ life cycles if that fits your enterprise’s culture
and goals but also letting you implement a more loosely structured system if that
better suits your enterprise.
Most importantly, the program allows you to save results reports as PDF files,
and data files or results tables in XPORT files. These formats are the prefered file
formats, recommended in the FDA “ Guidance for Industry; Providing Regulatory
Submissions in Electronic Format- General Considerations.”
Filing refers to how the documents are stored and organized within the
system. This is an important area since this would dictate how programs would
be fashioned to facilitate the retrieval of the data needed.
Security of course is essential since this refers to how the documents are
protected from loss, tampering, or destruction. Documents should be protected
from all this elements since the data stored on the systems are used as future
references and are also crucial for the development of a company. Security also
refers to how special documents may be accessed only by authorized people
concerned for a special project and not all of the employees of the company.
Retention refers to how long data and documents are to be filed and stored
on the system and which data are to be retained or deleted. This is governed by
retention policies of the system. This area must be critically made since no data
must be accidentally deleted or removed from the system and that the time of
retention must be maximized so that the system will not be flooded with data but
at the same time, data may be stored for the time these documents may still be
used or needed.
Archiving refers to the transfer of data or documents that has reached their
maximum lifespan on the system to another location (e.g. warehouses for paper
documents or offline storage devices for electronic data). When the documents
are archived, they can no longer be accessed online or cannot be retrieved as
easily.
Readability refers to the security of data from fires, floods or natural disasters
and the assurance that these data can still be retrievable and usable after such
events.
Distribution refers to how the documents are dispersed through the system
and how much cost it takes for this dissemination and access.
Workflow refers to how data are transferred from one person to another and
how they could access these documents in such a way that there is a hierarchy
of flow of access.
Creation refers to the number of people and collaboration logistics of how the
system will be made and tailored for the needs of the company. Authorized
people should be able to retrieve and edit documents whenever needed and not
allow others to access such document while it is being edited.