Computers have become integral tools for data management and analysis in pharmaceutical research and development, particularly during pre-clinical drug testing. Three key computer systems used are CDS for chromatographic data, LIMS for non-chromatographic data management, and TIMS for textual document management. These systems help efficiently collect, store, analyze, report, audit, and archive the large amounts of data required for IND applications and regulatory filings, improving productivity. FDA regulations like 21 CFR Part 11 have impacted system design to ensure data integrity and security.

1. Computers
as Data Analysis
in Preclinical Development
DR. SIDDHI UPADHYAY (M.PHARM, PH.D)
H.O.D. AND ASSOCIATE PROFESSOR
DEPARTMENT OF PHARMACOGNOSY AND PHYTOCHEMISTRY
SIGMA INSTITUTE OF PHARMACY, BAKROL, WAGHODIA, VADODARA

2. Introduction – 1/8
Computers in preclinical development has become an
integral part of pharmaceutical research and
development.
Computers have found their importance as data
management and data analysis tools in
Pharmaceutical R&D.

3. Introduction – 2/8
Pre-clinical development involves the testing of a prospective
drug on animals to determine its safety and dose that can be
used in humans.
After this initial study on animals, an Investigation New Drug
(IND) application needs to be filed with the regulatory
authorities.
An IND application may require as much as 50,000 pages of
supporting documentation.
The data for every single data point has to be collected,
managed, analyzed, reported, audited and finally archived as
per the prevailing regulatory laws.

4. Introduction – 3/8
The use of computers has led to efficiently completing the above
steps for the data collected hence increasing efficiency and
productivity of development.
The three computer based systems used to manage majority of the
data in the pre-clinical development stage include the CDS
(Chromatographic data systems), LIMS (Laboratory Information
Management Systems) and TIMS (Text Information Management
Systems).
There are several vendors available for these each of these systems.

5. Introduction – 4/8
 Chromatographic data System (CDS)
 Laboratory Information management System (LIMS)
 Text Information Management System (TIMS)
 It is probably fair to say that these 3 computer systems handle the majority of
the work in data / document management in the pre-clinical area, supporting
the filings of
 New Drug Application (NDA)
 Marketing Authorization Application (MAA).

6. Introduction – 5/8
 Documentation requirements in preclinical development: Several types of
controlled text documents used in preclinical development.
 SOP’s – Standard operating System
 Research records
 Laboratory Notebook
 Product specification documents and analytical test method.

7. Introduction – 6/8
There has been a strong impact of regulations,
specifically those that pertain to electronic document
management and electronic signatures, 21 CFR Part
11 published by the FDA (Food and Drug
Administration).
This has led to putting a check on the usage of
computers to aid pharmaceutical research and
development.

8. Introduction – 7/8
Some of the key features are as follows:
•Computer systems must be validated to ensure consistency of
intended purpose, accuracy and reliability.
•Computer systems must provide time based Audit Trial to record
actions for creating, modifying or deleting records.
•Access to computer systems used for research must be limited to
authorize personnel only.
•Computer systems should have the capability to be configured
specific to each user.

9. Introduction – 8/8
Part 11 is a regulatory requirement which has not been
enforced by the FDA however this has impacted the CDS,
LIMS and TIMS with respect to their design and security
capabilities.

10. Chromatographic data analysis (CDS) – 1/3
CDS is used for automating pharmaceutical analysis, mostly
those that pertain to
1. Chromatographic data generated from various test like
HPLC (High performance liquid chromatography)
2. GC (Gas Chromatography)
3. IC (Ion exchange chromatography)
4. CE (capillary Electrophoresis)
5. SFC (Super critical fluid chromatography).

11. Chromatographic data analysis (CDS) – 2/3
So far the CDS has been helping in providing accurate
and reliable data.
However, recently the regulatory filings have moved
from being data-based to information-based.
Thus there is scope of improvement for this
technology to lay more emphasis on data analysis
and signal detection.

12. Chromatographic data analysis (CDS) – 3/3
The importance of CDS is directly related to the roles that
chromatography, particularly high-performance liquid
chromatography (HPLC) and gas chromatography (GC), play in
pharmaceutical analysis.
HPLC and GC are the main workhorses in pharmaceutical analysis.
In today's pharmaceutical companies, development work cannot
be done without HPLC and GC.
CDS are also used for several other instrumental analysis
technologies such as ion (exchange) chromatography (IC), capillary
electrophoresis (CE), and supercritical fluid chromatography (SFC).

13. Laboratory Information management
System (LIMS)
LIMS provides data management capability for all
non chromatographic data that cannot be handled
by the CDS.
Another important function of LIMS is automation
of stability studies including sample tracking,
distribution, work assignment, result capturing,
data processing, review, approval, report
generation and data archiving, retrieving and
sharing.

14. Text Information Management System
(TIMS) – 1/2
TIMS is not used as widely as the LIMS, however, it
helps improve efficiency in managing business-critical
text documents.
However the process of manually writing, reviewing,
auditing and publishing text documents is time
consuming which is why the industry is working
towards the method of electronic submissions.
The truth is that we are still not there, and electronic
submissions may still take a while to be a reality.

15. Text Information Management System
(TIMS) – 2/2
Objectives of TIMS
◦It is organize and store the large amount of text.
◦It help the preclinical Development.
Need of TIMS
◦TIMS also called as Textual Information Management
System in literature.
◦These System deals various kind of documents which are
textual in nature.

16. THANK YOU !!!