data integrity challenges and solutions
TRANSCRIPT
Nandkumar Chodankar (Ph D Tech)
CEO
ASOLUTION PHARMACEUTICALS PVT. LTD.
“DATA
INTEGRITY”
The Current
Challenge
&
Solution
Data IntegrityData integrity refers to maintaining and assuring the accuracy and consistency of data over its entire life-cycle in compliance with its applicable regulatory requirements.
It is a critical aspect to the design, implementation and usage of any system which stores, processes, or retrieves data.
Data Integrity Froud: Alteration, Fabrication, Misrepresenation, Omission
Jan. 9, 20152Dr. Nandkumar Chodankar
Importance of Data
IntegrityPATIENT SAFETY
COMPLIANCE:
To ensure that the drug is not adulterated
as per 21 CFR
Failure to comply with any of the
proceeding regulations deems the drug
to be adulterated
Data should be unbiasedJan. 9, 20153Dr. Nandkumar Chodankar
Application Submitted- Accurate &
reliable
All records & Supporting documents are
accurate and true representation of
Actual tests performed & the actual test results
Quality control steps for Development & Manufacture of submission & regular batches
Any other action & conditions associated with application
Data Submission &
Application Integrity - 1
Jan. 9, 20154Dr. Nandkumar Chodankar
Data Submission &
Application Integrity - 2
Data and application integrity also
means the absence of a pattern of
unexplainable discrepancies between
data in records submitted to the FDA and
data in the original records maintained
by the applicant.
Jan. 9, 20155Dr. Nandkumar Chodankar
Data Submission &
Application Integrity - 3
UNRELIABLE:
Omission of significant data from
submission that is determined to
be material to the review process.
Data that is not submitted, but
should have been submitted.
Jan. 9, 20156Dr. Nandkumar Chodankar
Data Submission &
Application Integrity - 4
INACCURATE –
Examples:
First data that failed specs,
Retest data passes specs,
Lab investigations are inadequate or
non-existent, but retest data is
submitted to the application
Jan. 9, 20157Dr. Nandkumar Chodankar
Data Integrity
Data should be Generated as per
cGMP (21 CFR Requirements)
1. Reliable
2. Trustworthy
3. Traceable
4. Verifiable
5. Complete
6. Legible
7. Meaningful
&
9. Protected
Jan. 9, 20158Dr. Nandkumar Chodankar
DATA LIFE
CYCLE
1.
Collection2.
Processing
4.
Reporting
3.
Reviewing
Jan. 9, 20159Dr. Nandkumar Chodankar
Basic Questions
Who, When, What, How? 1. Collection: Who Collects the data? When the
data is Collected? What data is Collected? How data is Collected?
2. Processing: Who Processes the data? When data is Processed? What data is Processed? How data is Processed?
3. Reviewing: Who Reviews the data? When the data is Reviewed? What data is Reviewed? How data is Reviewed?
4. Reporting: Who Reports the data? When the data is Reported? What data is Reported? How data is Reported?
Jan. 9, 201510Dr. Nandkumar Chodankar
A Attributable Who performed the action & when? Record change, who did it and why?
Who performed?Source Data
L Legible Data must be recorded permanently in
durable medium & be readable Can you read it?
Permanent record
C Contemporan
eous
Data should be recorded at the time
work performanceWas it done in real
time?
O Original Is the information an original record or
certified true copy?Is it original or true
copy?
A Accurate No error or editing performed without
documented amendmentsIs it accurate?
Complete All data including repeat or reanalysis
performed on the sample21 CFR 211.194
Consistent Consistent application on data time
stamps in expected sequenceData/Time stamps
Enduring Recorded on controlled worksheets,
Laboratory Notebooks or mediaMedium used to
record data
Available Available /accessible for review /audit
for lifetime of the recordFor the life time of
the record
DATA - ALCOA
Jan. 9, 201511Dr. Nandkumar Chodankar
Fraud
Triangle
I need to
meet my
monthly
targets
Everyone
is doing it
Nobody
Really
Checks
Incentives
&
Pressures
Opportunity Attitude &
Rationalism
DATA FRAUD
Jan. 9, 201512Dr. Nandkumar Chodankar
What can Management do?
1. Showing transparency, accountability,
and responsibility
2. Staying involved
3. Set realistic expectations
4. Praising / Reprimanding (criticism)
5. Develop Team spirit
Continued-
Jan. 9, 201513Dr. Nandkumar Chodankar
What can Management do?
6. Have regular training, Audit and
Supervision
7. Routinely investigate all incidences,
deviations and Changes
8. Review oversight practices
9. Encourage feed back mechanism
without fear of consequences
Continued-
Jan. 9, 201514Dr. Nandkumar Chodankar
What can Management do?
10. Regular QA and QC data Review
11. Internal DI Audits of every department
12. Escalation & Governance
13. Technical Procedural control
14. Validation of every system
15. Risk assessment of all systems as well
operations
Continued-Jan. 9, 201515Dr. Nandkumar Chodankar
What can Management do?
16. Quality Manual – Culture and Policies
17. Trainer’s Qualification, refresher
training, evaluation
18. Security Management
19. Recruitment Policies and procedures
– Integrity check
Jan. 9, 201516Dr. Nandkumar Chodankar
What can Staff do?
1. From lowest to the highest they see it
all and thus can act
2. Everyone is Responsible, Reliable,
Confident
3. Routinely report their findings
4. Everyone considers that Quality
Assurance “as essential function” and
not as an added burden
Continued-Jan. 9, 201517Dr. Nandkumar Chodankar
What can Staff do?
5. Everyone should Respect quality and
should be proactive
6. Responsive to policies and procedures
7. Should report finding without fear of
consequences
8. Should be proud to represent quality
culture
Jan. 9, 201518Dr. Nandkumar Chodankar
Culture of ComplianceManagement Must
Establish culture from Top to Down
Convey a commitment to compliance
Actively work with and support quality
Establish and demonstrate clear policies on
cGMP and data integrity
Establish control
Intolerant to non-compliance
Understanding
TRUST once Broken is difficult to rebuild
Jan. 9, 201519Dr. Nandkumar Chodankar
Create Compliance Culture
Recruitment
Built into interview guide
Job profile
Performance
Management System
Management Priorities
Reward &
Recognition System
Succession
Management
Successful Profile
People
Development tools
and measures
Communication
Quality Principles, Quality
Briefings, News Letter
Internal Website
Quality Integrity
Sustainability SOPs
Jan. 9, 201520Dr. Nandkumar Chodankar
How to avoid Data Integrity
Problems1. Regular QA & QC Review
2. Internal Audit system along with
supervision
3. Escalation and Governance system
4. Technical Procedure Controls
5. Validation
6. Risk Assessment
Jan. 9, 201521Dr. Nandkumar Chodankar
7. Quality Manual with Management
Culture, Data Integrity Policies
8. Training, Trainers Qualification &
attitude, Effectiveness & evaluation,
refresher courses, etc.
9. Starts with “Small problems” which are
not given importance and they grow
into major problems
How to avoid Data Integrity
Problems
Jan. 9, 201522Dr. Nandkumar Chodankar
10. Obtaining valuable peace of
information from the staff - Why he /
she has manipulated or falsified ?
11. The inability to detect and prevent
data integrity breaches the trust
12. Detection of emerging trend is
important
13. Institutionalize, reinforce & reward
vigilant culture.
How to avoid Data Integrity
Problems
Jan. 9, 201523Dr. Nandkumar Chodankar
REMEMBER
21 CFR –Data Control SystemValidation
Change control and revisions
Protection of records
Access limitation
Audit Trail
Control of sequence
Source of data input
Prevent unauthorized use of passwordJan. 9, 201524Dr. Nandkumar Chodankar
OATH
I am a HONEST person with
HIGHEST INTEGRITY.
I have positive attitude and integrity.
I want to improve continuously.
You are not expected to be Perfect but certainly expected to be Honest.
You may make a mistake but hiding it is a crime.
Jan. 9, 201525Dr. Nandkumar Chodankar
THANK YOU
Nandkumar Chodankar (Ph D Tech)