This document provides guidance on good documentation practices. It emphasizes that documentation should be attributable, legible, contemporaneous, original, and accurate. Key points include: - Documentation is important for regulatory compliance and represents the quality of an organization's work. - Documentation must clearly show who performed and observed activities and when. - Original documents should be distinguishable from copies and have clear, concise information. - Data entries must be made at the time of the activity and any corrections clearly shown.

1. Prepared By:
Piyush V. Wagh
Senior Executive
Quality Assurance Department
Date: 16th Aug 18
Ref: image downloaded from kr.123rf.com

2. Good Documentation- Dos and Don’ts
Purpose of the Training.
Adapted from- Deviation reports (Quality Assurance Department )
0
2
4
6
8
10
12
14
Jan.18 Feb.18 Mar.18 Apr.18 May.18 Jun.18 Jul.18
No of deviation recorded for Documentation

3. Good Documentation- Dos and Don’ts
Good documentation practices (GDP) is required in order to ensure
an auditable account of work performed.
GDP is required for all documentations included in a fully developed
quality system.
To ensure the Integrity of the Data.
To represent the organization to Regulatory bodies worldwide.
To build the Best Organization and self development.

4. Good Documentation- Dos and Don’ts
“If it hasn't been documented, then it activity
hasn't done or happened!”
“If it is not documented, it is a rumour!”
This is the FDA Inspection Attitude
The product considered as “Adulterated” if the
procedure not followed/ not documented properly.

5. Good Documentation- Dos and Don’ts
Your documentation is
an advertisement for
your work.
Always Remember one thing
during your documentation.

6. Good Documentation- Dos and Don’ts
Key feature of GDP
 Careful design of documents should make them easy to read, easy to
understand and easy to complete properly
 Just creating documents is not enough; must follow specific standards
when doing so. Ensure user reads and understand exactly what it
means.
 Master documents must be subject to appropriate controls to ensure that
only one version is current. Such documents must be approved, signed
and dated.
 Modifications to master documents must be managed through change
control
 Original documents should be easily distinguishable from photocopies,
and should have clear and concise information

7. Good Documentation- Dos and Don’ts
Key feature of GDP
 Good documents should have sufficient space for entries, to record
variable information and signature and to attach print-outs etc.
 Data entries must be made or completed at the time the action is
performed.
 Entries in logbooks should be done in chronological order.
 It is necessary to document anything that directly impacts a product.
 Using a standard format eliminates discrepancies between documents
from different sources.

8. Good Documentation- Dos and Don’ts
Attributable Legible(Readable)
Contemporaneous
(On-line
correction)
Original
Accurate

9. Good Documentation- Dos and Don’ts
• Attributable- Does the documentation clearly demonstrate
• The link to it’s source (who it’s about)
• Who observed and record the information
• When data was observed and recorded.
A
• Legible (Readable):
• Can the information be easily understood?
• Is it recorded permanently on durable medium?
• Have original entries been preserved? (Not overwrite)
L
• Contemporaneous (On-line correction)-Was the information
recorded with timelines?
• Complete- Does the documentation include all the necessary
information?
C

10. Good Documentation- Dos and Don’ts
• Original- Is the Source information accessible and preserved in
its original form?.O
• Accurate:
• Does the recorded information describe the conduct the study
without error?
• Did the conduct of the study conform with the protocol?
• Who made the correction and when correction were made?
A
Ref: Adapted from FDA‐GUIDANCE FOR INDUSTRY‐COMPUTERIZED SYSTEMS USED IN CLINICAL
TRIALS ‐ ALCOA

11. Good Documentation- Dos and Don’ts
What is GDP?
Documentation: All records in any form (including, but not limited to,
written, electronic, magnetic and optical records, scans, X-rays and
electrocardiograms) that describe or record the methods, conduct and/ or
results of a trial, the factors affecting a trial and the actions taken. (Ref: ICH E6)
Good documentation practices are those measures that collectively and
individually ensure documentation, whether paper or electronic, is
attributable, legible, traceable, permanent, occurring, or originating
during the same time recorded, original and accurate.
(Ref: WHO GUIDANCE ON GOOD DATA AND RECORD MANAGEMENT PRACTICES -2005)

12. Good Documentation- Dos and Don’ts
 Attributable
 Legible
 Traceable
 Permanent
 Occurring or Originating During the Same Time Recorded
 Original
 Accurate

13. Good Documentation- Dos and Don’ts
Regulatory Guideline Sections about GDP (ICH GCP E6-R2)
If nothing is found during regulatory inspection then
simple overwriting correction or missing signature can be
given as “findings” under “Data integrity” issue if not
followed with good documentation practice.

14. Good Documentation- Dos and Don’ts
Examples 01

15. Good Documentation- Dos and Don’ts
Examples 02

16. Good Documentation- Dos and Don’ts
Examples 03

17. Good Documentation- Dos and Don’ts

18. Good Documentation- Dos and Don’ts
Best Documentation

19. Good Documentation- Dos and Don’ts
Some Interesting Digit Overwrites
Don’t Do that…. You
are employee not a
Labor

20. Good Documentation- Dos and Don’ts
Image downloaded from: https://www.quotemaster.org/being+right+and+wrong

21. Good Documentation- Dos and Don’ts
Do’s
 Record Every section.
Correct any data from source
data
(Form to CRF, Logbook to CRF)
Does correction need additional
comment?
Assign accurate “Error Code”
Adherence to SOP
Make Short or Long Signature
for correction.
Show quality instead if quantity
Don’ts
 Do Not Overwrite
 Do Not Overwrite
 Do Not Overwrite
 Do Not Overwrite
 Do Not Overwrite
 Do Not Overwrite
 Do Not Overwrite
 Do Not Overwrite

22. Good Documentation- Dos and Don’ts
Do’s
 Do online activity and record it
Do date signature after every
completion of activity
All manager/ GL must be
verified and checked every
record for its completeness.
Easy handwriting that everyone
can read properly.
Use “NA” or “NAV” for blank
spaces.
Don’ts
 Do not kept any blank space
 Do not use “-//-” ditto.
 Do not use Blue Ball point pen
 Do not Obstruct wrong entry
 Do not record only date
instead of dated signature.
 Don’t use pens like gel pens,
ink pens for making entries.
Don’t use pens like red, green
color ink.
 Pencil writing is not
acceptable,

23. Good Documentation- Dos and Don’ts
Before doing any documentation, ask this questions
to yourself…..
 Is my activity completed ?
 Is data recorded online?
 Shall accurate data/ true entry/ actual time
need to be documented?
 Is my “Source Documentation” is ok?
 Is my handwriting is readable by the
regulatory inspectors/ other person?
 Is my data original?

24. Good Documentation- Dos and Don’ts
Error Codes
Used only for “Missed Entry”.
• Only data which can be transcribed from other
documents can be entered.
shall be done for logistic or clerical works and used only
after printing of documents.
• Spelling mistake in the sentence or word or changes
any error occurred during writing / spelling mistakes-
Handwritten (Raw Data)
M
T
R

25. Good Documentation- Dos and Don’ts
Error Codes
Wrong Stamping
used for any printing error (e.g. word is not visible due
to printer ink; sentence is not visible due to column or
row size not proper.
S
P

26. Good Documentation- Dos and Don’ts
How to use Error Code?
 For correcting any error in raw data, draw a single line (horizontal line)
through the wrong entry without obscuring the original entry.
Eg.
Recording Time Recording Date Recorded By
15:03 15:1315:03
*
* R
XYZ
15th Aug 18
15:0515:05 15:25
#
#
R
ABC
15th Aug 18
XYZ
15th Aug 1815th Aug 18
15th Aug 18
ABC
15th Aug 18

27. Good Documentation- Dos and Don’ts
How to use Error Code?
Are you going to Obscure/
Overwrite the original
Entry?
Some one is watching you!

28. Good Documentation- Dos and Don’ts
Date format
Date Format :
Date Format is applicable for paper recording as well as electronic.
DD
st/nd/rd/th
Mmm YY
15th Aug 18
01st Aug 18
02rd Aug 18
03rd Aug 18
02nd Aug 1802rd Aug 18
* R
XYZ
15th Aug 18
*

29. Good Documentation- Dos and Don’ts
Time Format
Time Format :
Time Format is applicable on paper as well as electronic.
24 hr Format
HH:MM
13:03
23:59
01:10 pm01:10 pm 13:10 pm
* R
XYZ
15th Aug 18
* *13:10 pm

30. Good Documentation- Dos and Don’ts
Cost for Poor/No
Documentation
Cost for Good
Documentation
THEREFORE, DOCUMENTATION BRINGS BUSINESS

31. Good Documentation- Dos and Don’ts
Data Recording
Hmmmm, What do we do now?
What’s that number?
27 ?
29 ?
24 ?
2 %

32. Good Documentation- Dos and Don’ts
A Famous Proverb Says:

33. Good Documentation- Dos and Don’ts

34. Good Documentation- Dos and Don’ts
* R
XYZ
15th Aug 18
*