Data Integrity – Essentials & Solutions
Fréderique Backaert – November 8th 2016
What you will learn• Data Integrity – Why / What
• Data life cycle
• Core Data Integrity concepts & building blocks
• Short & mid-term actions enabling a focused road to compliance
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Data Integrity – Why
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Scope & Application
21 CFR Part 11FDA
2003
“generics scandal”late 1980s
Data IntegrityPilot Program
FDA2010
2007FDA
computerised systems in GCP
1997FDA
21 CFR Part 11Final Rule
QualityImpact on
Patient
Business
Oct, 2016CFDA
guidance (draft)
(draft) guidance PIC/SAug, 2016
Jul, 2016MHRA
guidance (draft)
guidelineWHOJun, 2016
Apr, 2016FDA
Data Integrity guidance (draft)
guidanceMHRA
Mar, 2015
2011EudraLex Volume 4 Annex 11
# 483 citations onData Integrity
topics
Insufficient data securityPoor data storage and archivesNo adequate data review processesPoor knowledge of data streams
Data Integrity part of routine GMP inspectionsFocus on raw data
Focus on computerised systems
Focus on “ALCOA”
“The extent to which all data are accurate, complete and consistent throughout the data life cycle” (MHRA, March 2015)
Applies for both electronic & paper-based documentation streams in GMP regulated environments.
Data Integrity – What
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validatedreviewed
data/metadata good documentation practicestraining method management
guaranteed throughout the legal
hold
“all phases in the life of data” (MHRA, March 2015)
Data life cycle
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Review
Creation Record ProcessingCalculations Report
Reprocessing
Recalculations
(Meta)Data Modification
s
Retirement Archive Retention Backup
Data owner
User - reviewer
User - author
Administrator
Core concepts:ALCOA Audit trail review
ALCOA model
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ALCOA
Attributable Legible
Cont
empo
rane
ous
Original
Accurate
• Acronym created by the FDA as a guide to the expectations concerning source data
A – Attributable
Who performed the action that gathered the data?
Paper Electronic
initials of author no generic login accounts
actions are documented & dated
metadata unambiguously linked
to data
good documentationpractices
validation for intended use
ALCOA model
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• Acronym created by the FDA as a guide to the expectations concerning source data
L – Legible
The data remains available & accessible throughout the life cyclePaper Electronic
permanent ink, single-line cross-outs
maintain human readability
reason of change old and new values
good documentationpractices
validation for intended use
ALCOA
Attributable Legible
Cont
empo
rane
ous
Original
Accurate
ALCOA model
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• Acronym created by the FDA as a guide to the expectations concerning source data
C – Contemporaneous
The data is recorded as the action takes place
Paper Electronicchronological
batch record design automatic saving
controlled printing date & time stamps cannot be altered
good documentationpractices
software designvalidation for intended
use
ALCOA
Attributable Legible
Cont
empo
rane
ous
Original
Accurate
ALCOA model
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• Acronym created by the FDA as a guide to the expectations concerning source data
O – Original
Documentation should be performed on original records
Paper Electronic
no scratches no copies of electronic records can be made
good documentationpractices
software designvalidation for intended
use
ALCOA
Attributable Legible
Cont
empo
rane
ous
Original
Accurate
ALCOA model
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• Acronym created by the FDA as a guide to the expectations concerning source data
A – Accurate
Records should be honest and thorough
Paper Electronic
witness checks technical controls on input fields
reason of change all changes are reviewed
good documentationpractices
audit trail reviewvalidation for intended
use
ALCOA
Attributable Legible
Cont
empo
rane
ous
Original
Accurate
automatic or
systematic
Audit trail review
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“metadata which represents a log of performed GMP-critical actions which facilitates a reconstruction of the performed GMP activities”
forensic
Analysis 1 Analysis 2 Analysis
3
Analysis performanceMethod managementUser managementData managementSystem configuration
frequency
Review 1 Review 3Review
2
Audit trail review
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“metadata which represents a log of performed GMP-critical actions which facilitates a reconstruction of the performed GMP activities”
Analysis performanceMethod managementUser managementData managementSystem configuration
frequency
Data review – Analysis audit trail
Part of batch release process
• actions in line with procedures and/or with pre-validated conditions
• accuracy, completeness & consistency of (meta)data
• focus on data creation, modification and deletion Review
1Review
2 Review 3
Audit trail review
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“metadata which represents a log of performed GMP-critical actions which facilitates a reconstruction of the performed GMP activities”
Analysis performanceMethod managementUser managementData managementSystem configuration
frequency
Analysis 1
Analysis 1
Review 1 Analysis 2 Review
2Analysis
3 Review 3 Periodic Review
Periodic review – System audit trail review
Frequency depends on modern QRM
• method creation or method parameter changes
• system configuration changes• data backup and/or archival• login of business admin or system admin• focus on holistic changes to instrument /
software
The road to compliance
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Data IntegrityCompliance
Quality SystemInstrumentSoftware
Qualification statusData management
CSV approach
Data Integrity policyCorporate security procedure
Measurement
TrendingCAPA handling
Deviation management
Culture
Company tolerance for common mistakes
Open communicationManagement responsibility
Materials
ProceduresAudit trail review
Data review tools
Ability & Motivation
Human
Day-to-day focus on
ALCOA principlesSeparated roles & responsibilities
Deviation management
The road to compliance
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Short-term actions
• Identify business processes with data streamsmapping of all business processes
• DI evaluations with pi’s proprietary DI Quick Scanassessment of both electronic and paper-based streams in business processes towards current DI requirements
quick matrix-based, system-by-system
efficient 1:1 relation with regulatory requirements
prioritised according to GMP criticality
Outcome
reveals non-conformities&identifies globalised CAPA plan
detailed data flows&GMP criticality of all data streams
The road to compliance
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Mid-term actions
• Data Integrity remediationfull project support including assessment program, driving
the CAPA plan and deployment of remediation.
• Data Integrity trainingsetting-up training programs tailored to different focus
areas: production, internal audit, quality assurance, quality control,
…
• Data Integrity strategyimplementing a risk-based, lean and effective data
integrity strategy, on par with the latest GMP requirements and
embedded within your corporate quality system.
Outcome
corporate-driven culture towards DI
Data Integrity compliance
secured base
Conclusions
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• Data Integrity remains to have a direct impact on patientbusiness and quality of product & processes.
• Data Integrity, as a KPI, is an indicator for LEAN data flows.
• DI Quick Scan is a swift assessment towards Data Integrity compliance for both paper & electronic based data streams.
• DI Quick Scan sets the standard for a roadmap towards Data Integrity compliance.
About the speakerFréderique BackaertBusiness Developerpi
Fréderique Backaert holds a PhD in Organic Chemistry and has been working for pi life sciences consultancy for more than two years. In the meanwhile, he has been challenged with specific data integrity improvement programs in the pharmaceutical industry. These experiences were the fundamentals of pi's risk-based solutions towards arising data integrity questions.
18 | © 2016 pi
pi is the strategic partner of choice to some of the world’s leading life science companies. We offer our clients unique expertise and strategic consultancy of the highest quality. Our Data Integrity services include:
About pi
DI Quick Scan• Two step process, on both paper and electronic records,
including a quick scan using our proprietary method and tools and in-depth audit of QC and manufacturing records.
• Thorough audit of your software, analysing whether or not they meet current data integrity requirements.
• An efficient yet detailed analysis, saving you time and assuring a minimal disruption of operations.
Data Integrity Remediation• Full project support, including assessment, driving the
CAPA plan and deployment and implementation of remediation
Data Integrity Strategy• Design and roll-out of a lean and effective data integrity
strategy, on par with the latest GMP requirements and embedded within your QMS
Data Integrity Training• On-site training on Data Integrity for management,
operations, QC and QA staff . • Focus on data integrity methodology and compliance
program, the importance of data integrity and on creating the right culture to maintain data integrity.
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References
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• 21 CFR Part 11 Electronic records; Electronic Signatures• Guidance for Industry, Part 11 Electronic records; Electronic Signatures – Scope & Application• Guidance for Industry Computerized Systems Used in Clinical Investigations • EudraLex Volume 4 Annex 11 - Computerised systems• MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015 • Data Integrity and Compliance With cGMP Guidance for Industry • Guidance on good data and record management practices • MHRA GxP Data Integrity Definitions and Guidance for Industry • Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments