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

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. Spotlight Discussion by John Berga: What should my GDP standards be?

2. Definition of……. What is the definition of Good Documentation Practices (GDP)? Concise, Legible, Accurate and Traceable records This simple statement encompasses all the requirements of GDP

3. Simple Statement, Hard Task? Now – we know the definition, but do we understand it? Concise: The document must tell the entire story and be understood by internal/external customers. Legible: The document must be readable by internal/external customers. Accurate: The document must be error free. Traceable: Each aspect of the document must be traceable, such as, who recorded it, where and why.

4. How Do We Make The Task Easy? Let’s examine what it means to be concise. Are our documents standardized? Are the documents easy for all to use? Do we have certain documents that consistently have errors? Do our documents tell a complete story: the beginning, the middle and the end…. to everyone? Once these questions are answered and resolved you can begin a new understanding of “concise”.

5. How Do We Make The Task Easy? Let’s examine what legible means. In it’s most simple form, legible means: Can everyone read what is written? No matter who, where or what, can the written or printed data be read by everyone?

6. How Do We Make The Task Easy? Let’s examine what it means to be accurate. Data shall be recorded as soon as possible and shall not be falsified. Simple? Not really. Anyone now has room to determine for themselves, when and how. A process must be formulated to catch any errors.

7. How Do We Make The Task Easy? Let’s examine what traceability means. Can everyone understand who recorded the data, why it was recorded, what was recorded and when it was recorded. Is everyone signing for what they recorded? Do we have a SOP that requires the record? Do we understand what it is we are recording? Can we determine when it was recorded? Standardized Documentation is KEY!!!!!

8. Why Should I Do This? Documents are objective evidence that actions or tasks have been performed. Regulatory Agencies do not have Code of Federal Regulations (CFR) requirements saying to do this. Why? Because GDP is an expected practice!!!!!!!

9. Why Should I Do This? Your documents can be subpoenaed into court! And anyone who worked with that document can also be subpoenaed into court regarding the document!

10. Which Records? Generally, it is a good practice to GDP all records. There are no consequencesfor doing to much, just doing to little. However, Quality System Records must always be reviewed for GDP.

11. What are Quality System Records? Good examples of Quality System Records are: Are there other types of Quality System Records? Absolutely, ask your Quality Management.

12. What am I responsible for? You are responsible for your signature: Written Signature Should at a minimum be your first initial and full last name. J. Doe Initials maybe used on any page of a document once your signature appears on that page. JD

13. What am I responsible for? You are responsible for your signature: Electronic Signature It shall never be transmitted or disclosed to anyone else You should never use someone else’s electronic signature

14. What am I responsible for? You are responsible for all recorded information before you……… WHAT????? WHY???? Yes, you should be reviewing all data before you to be sure no one has made any mistakes.

15. What do I do if I find a Mistake? All errors should be corrected by the person who created them. Or, if that person is not available, the error can be corrected by their manager Or, if that person is not available, the error can be corrected by the next highest member of management. And so on and so on……etc.

16. How Are Mistakes Corrected? Four simple steps: Draw a single line through the error Make the correction next to the error Write an explanation for the error Sign and Date the Correction

17. What do I do if I need more space? What to do if you don’t have enough space for the correction, explanation and/or signature and date. 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.

18. Example: My Name is Misspelled AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA My name is Jon * John AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA *misspelled J. Doe 01/01/2000

19. Is That All I Need To Know? Well this would depend on your Standard Operating Procedures (SOP). Likely no, there should be more. Do you have written SOP’s?

20. Ok, when in doubt what do I do? Ask, Ask, Ask – I can not stress this enough. Ask your Manager, Quality or a Company Auditor You are legally responsible for documents you sign!!! Remember, if you let an GDP error go, it will be worse later.

21. Thank you for your time! Please, leave a comment. If you want more information, please feel free to contact me through LinkedIn. My LinkedIn Profile - John Berga