created by Shruti Kargutkar

1. By: Shruti Kargutkar
Jr. Officer Regulatory Affairs
Inventia Healthcare Pvt Ltd

2. If it wasn’t documented,
It was’t done!
Document what is done as well as
what is not done!
-TGA & FDA

3. INTRODUCTION
 ALCOA was coined by Stan Woollen in the early
1990’s.
 1999 FDA Guidance: ALCOA - “To be acceptable
the data [from clinical trials] should meet certain
fundamental elements of quality whether
collected or recorded electronically or on paper.
Data should be Attributable, Legible,
Contemporaneous, Original, and Accurate”

4. DATA INTEGRITY
Generating, transforming, maintaining and
assuring the accuracy, completeness and
consistency of data over its entire life cycle
in compliance with applicable regulations.

5. DATA INTEGRITY ISSUES ?
 Undermines the Safety and Efficacy and/or
assurance of quality of the drugs
 Break trust

7.  Not recording activities contemporaneously.
 Backdating
 Fabricating data
 Copying existing data as new data
 Re-running samples
 Discarding data
 Releasing failing product
 Not saving electronic or hard copy data (old
communications not saved)

8. 0
10
20
30
40
50
60
70
80
Malaysia
Vietnam
France
Italy
Korea Republic(South)
United Kingdom
Taiwan
India
Mexico
Number of warning letters
Countrywise warning letters

9. Why are document standards
important?
 Good documentation practice is an expected
practice !
 Correct, complete, current and consistent
information
 Reduce observations raised on inadequate
documentation practices.

10. What constitutes Good
Documentation?
 Approve, review, update documents
 Changes and current revision status of documents
 Relevant versions of applicable documents available
at point of use.
 Documents remain legible and identifiable.
 Documents of external origin identified and their
distribution controlled.
 Prevent use of obsolete documents and archiving
 Password protected and IT controlled signatures

11. Observations on poor
documentation practices
 Document error correction
 Write- over
 Audit trail not documented
 SOP not authorized by QA
 The delegation for the batch release in case of
absence of the QA manager not
recorded/documented
 Out-of-specification (OOS) procedure not detailed
enough

13. •Loss Of Trust
•Form-483
•Warning Letter
•Import Alert
•Recalls
•Seizure
•Non compliance report
•Notice of concern
•Loss of Job
•Loss of Business
•Loss of money

14. 1. What might go wrong ?
2. What is the likelihood it will go wrong ?
3. What are the consequences ?
THINK ON YOUR OWN

15. WHILE FILING PATENT APPLICATIONS
- SOURCED /ORIGINAL DATA
- ALL DATA RELATED TO PATENT

16. DATA FULFILL α DATA ACCEPTABLE

17. Barriers
• Human Errors –
1. When data is entered by mistake
11. Not being aware of regulatory requirement or poor training
111. Willfully (falsification or fraud with the intent to deceive)
• Selection of good or passing results to replace that are
poor or failing
• Unauthorized changes to data
• Errors while transmitting data from one computer to another
• Changes to data through software bugs or malware of
which user is not aware
• Hardware malfunctions such as Disc Crashes
• Changes in technology where one item is replaced when it
becomes obsolete or no longer supported., making old
records unreadable or inaccessible.
• Shortage of system space for archival of legacy data

18. CFR - Code of Federal Regulations Title
21
CFR Title 21- Food and Drugs : Parts 1 to 1499
Part 11 – Electronic records , Electronic signatures
Part 58 – GLP for Nonclinical Laboratory Studies

20. ATTRIBUTABLE
It should be clear -
 Who When Why has documented the Data?
 Who When Why created record / changed
record?
The requirement for attribution of data to the
individual who collected it is found in 21 CFR
58.130 (e) According to the regulation, ‘’ all data
entries shall be dated on the date of entry &
signed or initialed by the person entering the data.

21. LEGIBLE
 Readable Data and Identifiable signatures
 Though legible, it should not interfere with other
principles
21 CFR 58.130 (e) addresses directly by requiring
that ‘’ Data shall be recorded directly, promptly
and legibly in ink.’’

22. CONTEMPORANEOUS
 As Observed
 Existing at or occurring in the same period of
time
 Originating / Existing/ Happening during same
period
21 CFR 58. 130 (e) ….. Data shall be recorded
directly, promptly and legibly.

23. ORIGINAL
 The first record made by an appropriate person
The terms source data or raw data embody this
concept of the first recording of data, and are
sometimes used interchangeably.
Source data is the term generally used in the context
of good clinical practices (GCP)
While GLP enthusiast use the term Raw data as it is
officially defined in the GLP regulations at 21 CFR
58.3 (k)

24. ACCURATE
 Accurate, consistent and real presentation of
facts
 An accurate diagnosis / free from error
 Conforming exactly to truth or to standard
21 CFR 58.130 (a) requires that a study must be
conducted in accordance with the protocol.
21 CFR 58.130 (b) requires test systems to be
monitored in conformity with the protocol.

25. ASK YOURSELF THESE QUESTIONS
 Who am I?
 What am I doing?
 What are my values?

26. References
 Joseph Saponaro, MD, DABIM, FACP, CPI, CCI,
CCTI, CCRC, CCRP
Board Certified Internal Medicine and
Pharmaceutical Medicine
DRUG STUDY INSTITUTE
 Data Integrity Issues : Causes and Solutions By
Elayne Best, Biogen Idec , Mar,30,2015
 The Compass- summer 2010 – Newsletter of the
Southern Regional Chapter Society or Quality
Assurance
 WIPO – World Intellectual Property Organization
(www.wipo.int)

27. References
 Regulatory Handbook : Data Integrity : FDA AND
GLOBAL REGULATORY GUIDANCE By Siegfried
Schmitt, Principal Consultant, Parexel Consulting
 Guidance for Industry Part 11, Electronic
Records; Electronic Signatures – Scope and
Application
 https://www.youtube.com/watch?v=GgtdqMXNb
C4

28. Thank you !