2. OBEJECTIVES
Main objective of Text Information
Management System is to encourage the:
Process of Writing
Reviewing
Auditing
Approving
Publishing the pharmaceutical text reports.
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3. Management information system
Management information system refers to
the processing of information through
computers and other intelligent devices to
manage and support managerial decisions
within an oraganization.
L.Kahari 3
5. Text information Management system
Text : Word or, group of words
Information: processed data or fact
Management: an art to make the things
done with proper resource at correct cost,
place and schedule.
System: to store the data & facts
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6. 6
Text information Management system
The name "text information management system"
is not as widely used as the name "laboratory
information management system." Nevertheless,
a text document management system is essential
in preclinical development because huge
numbers of text documents and other related
information such as images, drawings, and
photographs are generated in the area. All these
documents and information are considered
intellectual property and require protection and
easy access.
7. Text information Management system
Text information management systems help
the pharmaceutical Industry to improve
efficiency in managing business –critical text
documents.
The objective of an information retrieval
system is to organise and store large amounts
of text so that information can be retrieved
from the repositories in response to users
information requests.
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8. Text information Management system
Text information management systems
deals with bibliographic documents, legal
documents, official memos, patient records
& case history, letters, correspondences,
complete text articles and books and so on.
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9. TIMS: documentation requirements in
preclinical development
In preclinical development, the GMP/GLP
regulations are enforced not only for scientific
data but also for text documents. This section
discusses several types of controlled text
documents used in preclinical development.
Most of these documents are managed by the
fully validated TIMS.
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10. TIMS: documentation requirements in preclinical
development
In pre-clinical development, these (Product
specification documents and analytical test
methods) are important documents and they
evolve along with the development phases.
Drug substances and products for clinical
trials are tested based on these documents,
and so are the stability samples.
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11. TIMS: documentation requirements in preclinical
development
It is critical to ensure that the analyst will
perform the right tests against the right
specifications with the correct version of the
test method. Therefore a mechanism must be
in place to control these documents. This can
be done manually or with TIMS.
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12. TIMS: documentation requirements in preclinical
development
Most of these documents are managed by fully
validated TIMS:
SOP
Research report
Laboratory data
Product specification & Analytical Tests
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13. BENEFITS OF TIMS
Save time and energy
Faster method of report generation
Ensure accuracy Improve efficiency in managing
critical data
Strict security & reduce paper work
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14. REFERENCES
Stephen B. Harsh ,MANAGEMENT INFORMATION
SYSTEMS,Department of Agricultural Economics ,Michigan
State University.
Goyal Munish, Arora Varun, Shah S.K. Theory cum Practical
Computer Application In Pharmacy, PV Books, Edition 2018,
Page no. 93-94.
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