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Good Documentation Practices Presentation

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A simple approach to Good Documentation Practices from a Research/Development and/or Manufacturing view for Standard Operating Procedures.

Good Documentation Practices Presentation

  1. 1. Good Documentation Practices (GDP)Disclosure: The content of this presentation is for reference only and should not in anyway be used in place of your company GDP Policy. The content is a guideline only.<br />Spotlight Discussion by John Berga:<br />What should my GDP standards be?<br />
  2. 2. Definition of…….<br />What is the definition of Good Documentation Practices (GDP)?<br />Concise, Legible, Accurate and Traceable records<br />This simple statement encompasses all the requirements of GDP<br />
  3. 3. Simple Statement, Hard Task?<br />Now – we know the definition, but do we understand it?<br />Concise: The document must tell the entire story and be understood by internal/external customers.<br />Legible: The document must be readable by internal/external customers.<br />Accurate: The document must be error free.<br />Traceable: Each aspect of the document must be traceable, such as, who recorded it, where and why.<br />
  4. 4. How Do We Make The Task Easy?<br />Let’s examine what it means to be concise.<br />Are our documents standardized?<br />Are the documents easy for all to use?<br />Do we have certain documents that consistently have errors?<br />Do our documents tell a complete story: the beginning, the middle and the end…. to everyone?<br />Once these questions are answered and resolved you can begin a new understanding of “concise”.<br />
  5. 5. How Do We Make The Task Easy?<br />Let’s examine what legible means.<br />In it’s most simple form, legible means:<br />Can everyone read what is written?<br />No matter who, where or what, can the written or printed data be read by everyone?<br />
  6. 6. How Do We Make The Task Easy?<br />Let’s examine what it means to be accurate.<br />Data shall be recorded as soon as possible and shall not be falsified.<br />Simple? Not really. Anyone now has room to determine for themselves, when and how.<br />A process must be formulated to catch any errors.<br />
  7. 7. How Do We Make The Task Easy?<br />Let’s examine what traceability means.<br />Can everyone understand who recorded the data, why it was recorded, what was recorded and when it was recorded.<br />Is everyone signing for what they recorded?<br />Do we have a SOP that requires the record?<br />Do we understand what it is we are recording?<br />Can we determine when it was recorded?<br />Standardized Documentation is KEY!!!!!<br />
  8. 8. Why Should I Do This?<br />Documents are objective evidence that actions or tasks have been performed.<br />Regulatory Agencies do not have Code of Federal Regulations (CFR) requirements saying to do this. Why?<br />Because GDP is an expected practice!!!!!!!<br />
  9. 9. Why Should I Do This?<br />Your documents can be subpoenaed into court!<br />And anyone who worked with that document can also be subpoenaed into court regarding the document!<br />
  10. 10. Which Records?<br />Generally, it is a good practice to GDP all records. There are no consequencesfor doing to much, just doing to little.<br />However, Quality System Records must always be reviewed for GDP.<br />
  11. 11. What are Quality System Records?<br />Good examples of Quality System Records are:<br />Are there other types of Quality System Records? Absolutely, ask your Quality Management.<br />
  12. 12. What am I responsible for?<br />You are responsible for your signature:<br />Written Signature<br />Should at a minimum be your first initial and full last name.<br />J. Doe<br /> Initials maybe used on any page of a document once your signature appears on that page.<br />JD<br />
  13. 13. What am I responsible for?<br />You are responsible for your signature:<br />Electronic Signature<br />It shall never be transmitted or disclosed to anyone else<br />You should never use someone else’s electronic signature<br />
  14. 14. What am I responsible for?<br />You are responsible for all recorded information before you………<br />WHAT????? WHY????<br />Yes, you should be reviewing all data before you to be sure no one has made any mistakes.<br />
  15. 15. What do I do if I find a Mistake?<br />All errors should be corrected by the person who created them.<br />Or, if that person is not available, the error can be corrected by their manager<br />Or, if that person is not available, the error can be corrected by the next highest member of management.<br />And so on and so on……etc.<br />
  16. 16. How Are Mistakes Corrected?<br />Four simple steps:<br />Draw a single line through the error<br />Make the correction next to the error<br />Write an explanation for the error<br />Sign and Date the Correction<br />
  17. 17. What do I do if I need more space?<br />What to do if you don’t have enough space for the correction, explanation and/or signature and date.<br />Simple enough: Draw an asterisk (*) next to the error. Place the asterisk (*) on the same page where there is room to write. Now put your information there. <br />
  18. 18. Example: My Name is Misspelled<br />AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA<br />My name is Jon * John<br />AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA<br />*misspelled<br />J. Doe 01/01/2000<br />
  19. 19. Is That All I Need To Know?<br />Well this would depend on your Standard Operating Procedures (SOP).<br />Likely no, there should be more.<br />Do you have written SOP’s?<br />
  20. 20. Ok, when in doubt what do I do?<br />Ask, Ask, Ask – I can not stress this enough.<br />Ask your Manager, Quality or a Company Auditor<br />You are legally responsible for documents you sign!!!<br />Remember, if you let an GDP error go, it will be worse later.<br />
  21. 21. Thank you for your time!<br />Please, leave a comment.<br />If you want more information, please feel free to contact me through LinkedIn.<br />My LinkedIn Profile - John Berga<br />

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