Aragade Prity S.

(M. Pharm I semester)

13/12/20141

DOCUMENTATION

Presented by Guide

Prof. Aswar M.K.(Head of Pharmacology)

SINHGAD INSTITUTE OF PHARMACY, NARHE

CONTENT

IntroductionImportancePreparationTypesDocumentation processDocumentation technique Applications

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INTRODUCTION

A communicable material which contain systematically written specification, graphical presentation, description, procedure, instruction, observations regarding some attributes of system, such as its parts, assembly, installation, maintenance and use.

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IMPORTACE OF DOCUMENTATION

Avoids confusion Reflects each step Review on or focuses on each step Proper presentation of data Increases convenience to judge performance Important in research proposal Saves time Reference for new comers

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PREPARATION OF DOCUMENTATION

Documentation should be Simple Clear Accurate Meaningful Point wise Permanent Complete Truthful

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TYPES OF DOCUMENTATION

Personal document • Include autobiography, diaries, memories, letters,

observations • Utilized for research purpose (play major role in research)

Company document• Require document to operate every process effectively • Include proposal, contract, report detailed summary,

financial statement

Public document• Document  issued or published for public knowledge.• Court records, land deeds, and public registers

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DOCUMENTATION PROCESSGood documentation

Storage of documentation 13/12/2014 7

Good documentation

Clear Concise User friendly Nicely written Less words Point wise

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Examples of documents

Thesis Book Manuscripts Case history News paper article Bank documents Insurance document

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Right amount of documentation

Work instructions written for virtually everything

Overlap and repetition

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Avoid Creating too Much

Or too little

• Lack of work instructions where the process affects the quality of the product.

• Employees have their own way of performing processes

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Document control system

What should be control

Procedures

Attachments

Forms

Work instructions

Manual

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Clarify terminologies Procedures : Describes the processWork instruction : Tells how to perform the

processAttachments : Information attached to the

procedure to help clarify the procedure.ManualsForm

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Selection of specific system for documentation based on

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Research work

Company size

Computer set-up and availability

Number of different process performed

Rate of change in documentation

Storage of documentation

A simple word processing program.

For example, Word.An existing database program A packaged document control software.

Document stored in following format

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Simple hardcopy system

Procedure and work instruction are written on paper and place near the equipment

E.g. Standard operating procedure (SOP) of FTIR, SOP of U V visible spectrophotometer

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Online system

Procedure and work instruction are written in or loaded into the system

Document can printed , having validity for a day they are printed

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Documentation technique

Manual •Note card •sheet•chart

Electronic

•Software's

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Tab.1 Note card documentation format

TITLE To study accelerated stability study of paracetamol

PURPOSE To check stability

HYPOTHESIS Sample may be stable

SAMPLE paracetamol

TEST Accelerated stability testing

RESULT Drug is stable

REFERENCES ICH guideline

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Manual documentation

Tab.2 Sheet and chart documentation format

TEST DATE

SR.NO SAMPLES OBSERVATIONS MEAN OBSERVATIONS

A B C

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Title : Accelerated stability studyDRUG AND HPMC

Sr No

40° C & 75% RH 30° C & 65% RH

Days Percentage Assay %

Days Percentage Assay %

1 7 51.52 7 55.97

2 14 - 14 -

3 21 242.35 21 51.84

4 28 23.96 28 24.97

Electronic documentation

Software's used in documentation

Spreadsheet

Lotus 1-2-3 and MS-DOS spreadsheet

Microsoft Excel

IBM Lotus symphony

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Computer assisted telephone interviewing (CATI)

Computer assisted personal interviewing (CAPI)

Computer assisted web interviewing (CAWI)

Statistical package for the social sciences(SPSS)

Spreadsheet

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These are frequently used for financial information because of their ability to recalculate the entire sheet automatically after a change to a single cell

IBM Lotus symphony

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It is a suite of applications for creating, editing, and sharing text, spreadsheet, presentations and other documents and browsing the world wide web.

Computer assisted telephone interviewing (CATI)

It allows the interviewers to perform multiple tasks of interviewing , data entry and simple coding simultaneously.

The interviewers feed the information directly into the computer system.

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Computer assisted personal interviewing (CAPI)

It is an interview technique similar to CATI except that the interview takes place in person instead over the telephone

If no interviewer is present , the term computer assisted self interviewing (CASI) may used

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Computer assisted web interviewing (CAWI)

It is an Internet Data Collection (IDC) method.

The CAWI questionnaires appear onto the browser in one or more web-pages and respondents can reach in different way

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Statistical package for the social sciences (SPSS)

Commonly used for

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Market research

Survey companies

Health researchers

Government

Educational researcher

• Education

Provide a large data bank of information

Aid to time-tabling• Commerce

Assist the production of text material (known as word processing) such as reports, letters, circulars etc.

• Banks and Financial Institutions

Cheque handling

Updating of accounts

Applications

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• Management

Planning of new enterprises

Finding the best solution from several options• Industry

In process control

In production control

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Key Reference Kokare C.R., (2013), Research Methodology, First

Edition, Nirali Prakashan , Pune,14.1-14.8. http://www.ismp.org/quarterwatch/pdfs/2013Q1-Kids-

Special.pdf (Accessed:26/10/2014). McKenna E., Business Psychology and Organizational

Behavior : A Students Handbook, Third Edition, Vikas Publishing House, Jangpura,18-21.

http://www.esds.ac.uk/news/goodPractice.pdf (Accessed:24/10/2014).

https://kiedit.ki.se/sites/default/files/h9_handbok_forskningsdokumentation.pdf( Accessed:23/10/2014).

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http://www.unesco.org/education/aladin/paldin/pdf/course02/unit_01.pdf (Accessed:24/10/2014).

http://www.cdc.gov/healthyyouth/evaluation/pdf/brief18.pdf (Accessed:23/10/2014).

http://ebooks.narotama.ac.id/files/Core%20Concepts%20of%20Accounting%20Information%20Systems/CHAPTER%203%20Documenting%20Accounting%20Information%20Systems.pdf (Accessed:25/10/2014).

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