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Vidyasagar Independent Consultant sagaredoc@gmail.com
Causes – Consequences – DMS related Hot Fixes
Vidyasagar Independent Consultant sagaredoc@gmail.com
What is data integrity?
Data integrity – Popular causes, Consequences & DMS
related hot fixes
Data integrity – GAP assessment
Regulatory requirements 21 CFR Part 11
Application Integrity Policy
Data integrity – Conclusion
Table of Contents
Vidyasagar Independent Consultant sagaredoc@gmail.com
Integrity as being the quality or condition of being whole or undivided
completeness.
In the context of laboratory data integrity within a GMP environment, this
can be defined as:
“Generating, transforming, maintaining and assuring the accuracy,
completeness and consistency of data over its entire life cycle in
compliance with applicable”
What is Data Integrity?
Vidyasagar Independent Consultant sagaredoc@gmail.com
Data integrity and the lack of complete data over the record retention period can be compromised in a number of ways, such as:
Human errors
when data is entered by mistake (an uncorrected fat finger moment),
stupidity (not being aware of regulatory requirements or poor training) or
willfully (falsification or fraud with the intent to deceive)
Unauthorized changes to data made post-acquisition
Errors that occur when data is transmitted from one computer to another
Changes to data through software bugs or malware of which the user is not aware
Hardware malfunctions, such as disk crashes
Changes in technology, where one item is replaced when it becomes obsolete or no longer supported, making old records unreadable or inaccessible.
Data Integrity – Popular Causes
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Loss of Trust
Recalls
Form – 483
Warning or Untitled Letter
Import Alert
Injunction
Seizure
Application Integrity Policy Invocation
Non-compliance Report
Notice of Concern
Data Integrity – Consequences Loss of job
Loss of business
Loss of money
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Implement DMS application (as per US FDA 21 CFR Part 11 guidance)
Product dossiers, plant records etc must be digitized
Provide electronic traceability to all forms of records (digitized & physical)
Audit trail functions must be enabled at all times
Controls to prohibit unauthorized changes to electronic data
Critical business records are to be saved in DMS (not to be saved on personal
computers)
No sharing passwords / unauthorized access
Provide high security to DMS
Maintain DMS and electronic data backups
Have a policy to review software and data migration every 3 years
Data Integrity – DMS related Hot Fixes
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Conduct an inventory of current DMS applications
Determine if the systems complies with Part 11 guidelines
Identify their weaknesses and strengths
Conduct the assessment using a checklist or spreadsheet
Provide documented justification if certain systems are exempt from Part 11
Implement and execute a remediation plan
Have a plan for legacy records & data migration to DMS
Conduct the required follow-up as warranted
Data Integrity – GAP Assessment
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Regulatory Requirements
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Vidyasagar Independent Consultant sagaredoc@gmail.com
Doc Management software
21 CFR Part 11 compliance
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US FDA Regulatory Requirements for Data Integrity?
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..contd..
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Extract: 21 CFR Part 11 – Human Readable Format!
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Extract: 21 CFR Part 11 – Hybrid Situation!
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21 CFR Part 11 – Summary
1. FDA will consider electronic record to be equivalent to paper record
2. Electronic signatures will be deemed equivalent to traditional and written signatures
3. Provision of controls for closed system
4. Provision of controls for open system
5. Production of records in human readable format for inspection:
a) Copies of product dossiers & plant records are acceptable, subject to;
b) Maintenance of hybrid situation consisting of paper, converted electronic record & signature components for retention & traceability
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The Application Integrity Policy is what FDA pulls up when it has questions
about a manufacturer’s electronic data.
Electronic information includes everything, such as batch records, quality
control records, research lab records, emails, adverse events reports,
complaints—everything that’s stored electronically.
Application Integrity Policy (AIP)
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Attributable — digitized records has authenticity, retention & traceability
Legible — can read all the data without ambiguity
Contemporaneous — documented at the time of the activity
Original — traceability to original prints or observation or a certified copy thereof
Accurate — no errors or editing without documented amendments
Complete — all printed records from manual and simple software tests
Available — for review and audit or inspection over the lifetime of the record
Policy — have a clear policy / procedure on various activities (e.g. Password, Digital Signature policy)
Administration — have clear procedure and controls over the electronic data /software administration
Responsibilities — have a well defined cross check Privileges Vs. Job responsibilities
Auditable — period checks of the adequacy of the procedures
Application Integrity Policy (AIP) – Regulatory checks
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The integrity of data generated by any regulated laboratory is a prime factor in determining the credibility of that laboratory
The finding of a single instance where data integrity is compromised casts a shadow over the whole of the data generated
Remember that inspections and audits can only sample, finding one instance of falsification raises the question of how many more instances of non-compliances exist?
Therefore, ensuring data integrity is of major importance to analytical scientists, managers and quality assurance of any organization, as the consequences of getting it wrong are very costly and it will take a long time to rebuild regulatory trust
Data Integrity – Conclusion
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The extended FDA regulation and draft guidance now also impact the laboratory data integrity issue, as failure to provide complete records means that any drugs are now classified as adulterated under the new extension of the Food Drug and Cosmetic Act as amended in 2012.
Data integrity issue is prevalent globally and not merely India centric. If the pharmaceutical industry in the country is engaged in the production of life-saving drugs then it cannot afford to be negligent.
The industry needs to be careful and it is absolutely fair by global regulators to keep tabs on this.
Data Integrity – Conclusion
Vidyasagar Independent Consultant sagaredoc@gmail.com
Vidyasagar
Bangalore
INDIA
sagaredoc@gmail.com
Contact:
http://www.pdfa.org http://www.aiim.org
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