1. In FDA-regulated Industries Good Documentation Practices
Quality & Compliance
In FDA-regulated Industries
Good Documentation Practices
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2. Good Documentation Practice
What are they?
Standards by which documents are created and maintained.
Not codified by FDA, but are considered cGMP.
While not law:
Authorities will inspect against these guidelines and cGMP expectations.
Make observations if not in place.

3. Good Documentation Practice
Why are they needed?
To standardize the documentation practices throughout the industry.
To increase and assure the accuracy, quality and integrity of data, documents and records.

4. Good Documentation Practice
Who needs to implement them?
EVERYONE! Cleaning Logs Training Records
ALL POSITIONS! Correspondence

5. Good Documentation Practice
What are the standards?
Creation of New Documents
Review and Approval of Documents
Completion of Documents - Data Entry
Reproduction of Documents - Copying
Maintenance of Documents
Modification of Documents - Change

6. Good Documentation Practice
What are the standards?
Creation of New Documents:
Contemporaneous (Timely)
Typed (Not Handwritten)
Checked for Accuracy (Error-free)
Formatted for Trend Evaluation
Adequate space for data entries
For SOPs, include:
Process Flow Diagram
RACI Matrix (Responsible, Accountable, Consulted, Informed)

7. Good Documentation Practice
Process Flow Diagram – Example

8. Good Documentation Practice
RACI Matrix - Example

9. Good Documentation Practice
What are the standards?
Review and Approval of Documents
Reviewed by appropriate and authorized personnel
Approved by appropriate and authorized personnel
Signed
Dated

10. Good Documentation Practice
What are the standards?
Completion of Documents - Data Entry – The Dos)
Make entries in permanent/indelible Ink (NOT RED)
Make entries Concise, Accurate and Legible
Enter data in English (unless otherwise directed)
For Critical Entries, have a second authorized person independently verify activity/entry
Number the pages to be added:
Actual Page # followed by Total Page #
Follow company’s format for Date and Time:
Format cannot have numerous different meanings

11. Good Documentation Practice
What are the standards?
Completion of Documents - Data Entry – The Dos)
Follow company’s format for Initials and Signatures
Signatures and initials are serve as an employee’s confirmation that the activity performed was per the appropriate SOP or Work Instruction.
Signatures and initials have company-specific, legal, and/or ethical ramifications.

12. Good Documentation Practice
What are the standards?
Completion of Documents - Data Entry – The Dos)
For incorrect data entries:
Use a single line-out
Leave original date/entry legible
Sign or initial
Date
At the time that the correction is made
Include justification of the correction
Concise and Accurate

13. Good Documentation Practice
What are the standards?
Completion of Documents – Data Entry – The Don’ts
Make entries on the reverse side of the document
Unless a note is written on the front page
Leave spaces blank
If unused, cross-out or enter "N/A" (or similar text)
Use pencils!
Entries must be in indelible ink
Use ditto marks (‘’)
Use continuation lines
Use signature stamps

14. Good Documentation Practice
What are the standards?
Completion of Documents – Data Entry – The Don’ts
Obliterate data / entries - original data / entries must remain legible
Overwrite data / entries – scribble / marker
Use Corrective Solutions (e.g., Wite-out®)
Use Corrective Tape
Omit data
Falsify data

15. Good Documentation Practice
What are the standards?
Completion of Documents – Data Entry – The Don’ts
Back date
Use current date and include an explanation of the delay
Destroy or remove pages – obscures data that were present
To invalidate a page, use a single line cross-out, then initial and date it.

16. Good Documentation Practice
What are the standards?
Completion of Documents – Data Entry – The Don’ts
Transcribe Data – obscures original data
Data Transcription may prove helpful if original is of poor quality writing or is physically damaged
If used, should be clearly marked as a transcription and the original retained.
Use Scrap Paper or Post-it® Notes to record raw data
Temporary, non-official record

17. Good Documentation Practice
What are the standards?
Completion of Documents – Data Entry – The Don’ts
Use asterisks (*) where there is insufficient space for a fully notated hand change
Use a number near the correction, and record the same number along with a notation where this is sufficient space.
Reduces the risk that an additional change made by another person will not use the same mark.
Sign / initial for another person
Can sign of behalf of the other person, but must identify this along with an explanation.

18. Good Documentation Practice
What are the standards?
Reproduction of Documents – Copying
Clear and Legible
No Errors are introduced
Copy must remain identical to the original
Watermarks are sometimes used to identify original document from copies.
DRAFT

19. Good Documentation Practice
What are the standards?
Maintenance of Documents
Periodically Reviewed to Keep Current
Securely Retained
Change Control Program
Controlled Availability for Appropriate Duration
Electronic Document Management Systems (EDMS) must be Validated
Electronic Records are Backed-up and Archived

20. Good Documentation Practice
What are the standards?
Modification of Documents – Change
Handwritten modifications – signed/ dated
Altered text is not to be obscured
Justification for alteration must be noted
Controls to prevent use of superseded documents
Versions can only be modified by authorized personnel
Access to electronic versions must be controlled by password or other means
A history (audit trail) must be maintained of changes and deletions to electronic versions

21. Good Documentation Practice
Data
Significant Figures: All non-zero digits are significant, all zeros to the left of a nonzero digit are not significant, and a decimal point has no bearing on what numbers are significant.
The number of significant figures in the final result is determined by the significant figures of the original numbers.

22. Good Documentation Practice
Data
Significant Figures: (Continued)
Examples:
67 mg - All digits are significant - no “0”s.
0.067 g – Two digits are significant – “6” and “7”. The “0”s are not significant - only hold decimal place.
g – Three digits are significant - “6”, “7” and the far right “0” which identifies the limit that the substance was weighed to ( g).

23. Good Documentation Practice
Data
Significant Figures:
Examples: (Continued)
670 mg - Two digits are significant – “6” and “7”; however, the “0” may or may not be significant.
The “0” may hold the decimal place in which case it is not significant.
The “0” may identify the limit that the substance was weighed to (1 mg).
Resolutions:
Record value as 0.67 g or g
Use scientific notation.

24. Good Documentation Practice
Data
Significant Figures: (Continued)
Using Significant Figures for Calculations
Addition and Subtraction: Final value has only as many figures to the right of the decimal as there are in the number having the least number of figures to the right of the decimal.
Example:
111.1

25. Good Documentation Practice
Data
Significant Figures:
Using Significant Figures for Calculations (Continued)
Multiplication and Division: Final value only has many figures as in the value with the least number of figures.
Example:
11.1 x

26. Good Documentation Practice
Data
Significant Figures:
Using Significant Figures for Calculations (Continued)
Scientific Notation: All values expressed as 10# with one significant figure to the left of the decimal point.
Examples:
x 102
x 102
1.23 x 10-2
x 10-1

27. Good Documentation Practice
Data (Continued)
Rounding-off: Process by which one reduces the number of figures in a value.

28. Good Documentation Practice
Data
Rounding-off: (Continued)
Focus on the digit to the right of the last place in the limit expression.
If this digit is < 5, it is eliminated and the preceding digit is unchanged.
If the digit is > 5, it is eliminated and the preceding digit is increased by one.
If this digit = 5, the 5 is eliminated and the preceding digit is increased by one.
For calculations, do not round values until final result is calculated.

29. Good Documentation Practice
Data (Continued)
Truncation: Reduces the number of figures in a value by deleting the unnecessary figures.
No other change is made to the remaining number.
Unlike Rounding-off, only the last several digits in a numerical string are dropped.

30. Good Documentation Practice
Data
Truncation: (Continued)
Consider the significance of digits to the final result.
Do not truncate values until the final result is calculated.
Example:
Values not truncated prior to calculation:
x = 56.36
Values truncated prior to calculation:
456 x 0.1 = 45.6

31. CONFIDENTIALITY What’s the Big Deal? Company’s Code of Ethics
Adopted by companies to enable employees to:
Understand difference between 'right' and 'wrong'
Apply understanding to their business decisions.
Implies documents at three (3) levels:
Codes of Business Ethics
Codes of Conduct for Employees
Codes of Professional Practice

32. CONFIDENTIALITY What’s the Big Deal?
Codes of Professional Practice (Continued)
Honesty
Integrity
Transparency
Accountability
Confidentiality
Objectivity
Respectfulness
Obedience to the Law

33. CONFIDENTIALITY What’s the Big Deal?
Codes of Professional Practice (Continued)
Confidentiality - "confidential information"
Trade Secret:
A formula, practice, process, design, instrument, pattern or compilation of information
Not generally known or reasonably ascertainable
Require reasonable measures to protect the information
Enables a company to obtain an economic advantage over competitors

34. CONFIDENTIALITY What’s the Big Deal? Trade Secret (Continued) Impact:
Intellectual Property:
Copyright
Patent
Trademark
Time To Market
Competitive Advantage
MONEY!

35. Summary GDPs are considered cGMP. All employees must follow GDPs.
Original data and entries must not be obliterated; must remain legible.
Follow the GDP Dos and Don’ts.
Always use the current date.
Know what you are signing/initialing.
Follow company policies/SOPs on significant figures, rounding-off and truncating values.
Protect your company’s trade secrets by maintain confidentiality.

36. END