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Priti Aragade

Documentation is related to the pharmaceuticals how to store documents, their types of storage,method of storage with different software's used in it.

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Aragade Prity S. (M. Pharm I semester) 13/12/2014 1 DOCUMENTATION Prof. Aswar M.K. (Head of Pharmacology) SINHGAD INSTITUTE OF PHARMACY, NARHE
CONTENT Introduction Importance Preparation Types Documentation process Documentation technique Applications 13/12/2014 2
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. 13/12/2014 3
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 13/12/2014 4
PREPARATION OF DOCUMENTATION Documentation should be Simple Clear Accurate Meaningful Point wise Permanent Complete Truthful 13/12/2014 5
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 13/12/2014 6
DOCUMENTATION PROCESS Good documentation Right amount of documentation Document control system Storage of documentation 13/12/2014 7
Good documentation Clear Concise User friendly Nicely written Less words Point wise 13/12/2014 8
Examples of documents Thesis Book Manuscripts Case history News paper article Bank documents Insurance document 13/12/2014 9
Right amount of documentation Work instructions written for virtually everything Overlap and repetition 13/12/2014 10 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 13/12/2014 11
Document control system What should be control Procedures Attachments Forms Work instructions Manual 13/12/2014 12
Clarify terminologies Procedures : Describes the process Work instruction : Tells how to perform the process Attachments : Information attached to the procedure to help clarify the procedure. Manuals Form 13/12/2014 13
Selection of specific system for documentation based on 13/12/2014 14 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 13/12/2014 15
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 13/12/2014 16
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 13/12/2014 17
Documentation technique Note card sheet chart Manual Software'sElectronic 13/12/2014 18
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 13/12/2014 19 Manual documentation
Tab.2 Sheet and chart documentation format TEST DATE SR.NO SAMPLES OBSERVATIONS MEAN OBSERVATIONS A B C 13/12/2014 20
13/12/2014 21 Title : Accelerated stability study DRUG AND HPMC Sr No 40属 C & 75% RH 30属 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 13/12/2014 22
13/12/2014 23 Computer assisted telephone interviewing (CATI) Computer assisted personal interviewing (CAPI) Computer assisted web interviewing (CAWI) Statistical package for the social sciences(SPSS)
Spreadsheet 13/12/2014 24 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 13/12/2014 25 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. 13/12/2014 26
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 13/12/2014 27
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 13/12/2014 28
Statistical package for the social sciences (SPSS) Commonly used for 13/12/2014 29 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 13/12/2014 31
Management Planning of new enterprises Finding the best solution from several options Industry In process control In production control 13/12/2014 32
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_forsk ningsdokumentation.pdf( Accessed:23/10/2014). 13/12/2014 32
http://www.unesco.org/education/aladin/paldin/pdf/cour se02/unit_01.pdf (Accessed:24/10/2014). http://www.cdc.gov/healthyyouth/evaluation/pdf/brief1 8.pdf (Accessed:23/10/2014). http://ebooks.narotama.ac.id/files/Core%20Concepts%2 0of%20Accounting%20Information%20Systems/CHA PTER%203%20Documenting%20Accounting%20Infor mation%20Systems.pdf (Accessed:25/10/2014). 13/12/2014 34
13/12/2014 34

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Documentation

  • 1. Aragade Prity S. (M. Pharm I semester) 13/12/2014 1 DOCUMENTATION Prof. Aswar M.K. (Head of Pharmacology) SINHGAD INSTITUTE OF PHARMACY, NARHE
  • 3. 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. 13/12/2014 3
  • 4. 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 13/12/2014 4
  • 5. PREPARATION OF DOCUMENTATION Documentation should be Simple Clear Accurate Meaningful Point wise Permanent Complete Truthful 13/12/2014 5
  • 6. 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 13/12/2014 6
  • 7. DOCUMENTATION PROCESS Good documentation Right amount of documentation Document control system Storage of documentation 13/12/2014 7
  • 8. Good documentation Clear Concise User friendly Nicely written Less words Point wise 13/12/2014 8
  • 9. Examples of documents Thesis Book Manuscripts Case history News paper article Bank documents Insurance document 13/12/2014 9
  • 10. Right amount of documentation Work instructions written for virtually everything Overlap and repetition 13/12/2014 10 Avoid Creating too Much
  • 11. Or too little Lack of work instructions where the process affects the quality of the product. Employees have their own way of performing processes 13/12/2014 11
  • 12. Document control system What should be control Procedures Attachments Forms Work instructions Manual 13/12/2014 12
  • 13. Clarify terminologies Procedures : Describes the process Work instruction : Tells how to perform the process Attachments : Information attached to the procedure to help clarify the procedure. Manuals Form 13/12/2014 13
  • 14. Selection of specific system for documentation based on 13/12/2014 14 Research work Company size Computer set-up and availability Number of different process performed Rate of change in documentation Storage of documentation
  • 15. A simple word processing program. For example, Word. An existing database program A packaged document control software. Document stored in following format 13/12/2014 15
  • 16. 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 13/12/2014 16
  • 17. 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 13/12/2014 17
  • 18. Documentation technique Note card sheet chart Manual Software'sElectronic 13/12/2014 18
  • 19. 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 13/12/2014 19 Manual documentation
  • 20. Tab.2 Sheet and chart documentation format TEST DATE SR.NO SAMPLES OBSERVATIONS MEAN OBSERVATIONS A B C 13/12/2014 20
  • 21. 13/12/2014 21 Title : Accelerated stability study DRUG AND HPMC Sr No 40属 C & 75% RH 30属 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
  • 22. Electronic documentation Software's used in documentation Spreadsheet Lotus 1-2-3 and MS-DOS spreadsheet Microsoft Excel IBM Lotus symphony 13/12/2014 22
  • 23. 13/12/2014 23 Computer assisted telephone interviewing (CATI) Computer assisted personal interviewing (CAPI) Computer assisted web interviewing (CAWI) Statistical package for the social sciences(SPSS)
  • 24. Spreadsheet 13/12/2014 24 These are frequently used for financial information because of their ability to recalculate the entire sheet automatically after a change to a single cell
  • 25. IBM Lotus symphony 13/12/2014 25 It is a suite of applications for creating, editing, and sharing text, spreadsheet, presentations and other documents and browsing the world wide web.
  • 26. 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. 13/12/2014 26
  • 27. 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 13/12/2014 27
  • 28. 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 13/12/2014 28
  • 29. Statistical package for the social sciences (SPSS) Commonly used for 13/12/2014 29 Market research Survey companies Health researchers Government Educational researcher
  • 30. 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 13/12/2014 31
  • 31. Management Planning of new enterprises Finding the best solution from several options Industry In process control In production control 13/12/2014 32
  • 32. 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_forsk ningsdokumentation.pdf( Accessed:23/10/2014). 13/12/2014 32
  • 33. http://www.unesco.org/education/aladin/paldin/pdf/cour se02/unit_01.pdf (Accessed:24/10/2014). http://www.cdc.gov/healthyyouth/evaluation/pdf/brief1 8.pdf (Accessed:23/10/2014). http://ebooks.narotama.ac.id/files/Core%20Concepts%2 0of%20Accounting%20Information%20Systems/CHA PTER%203%20Documenting%20Accounting%20Infor mation%20Systems.pdf (Accessed:25/10/2014). 13/12/2014 34