Data Integrity webinar - Essentials & Solutions

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

pi | [email protected] | www.3-14.com2 | © 2016 pi

Data Integrity – Why


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


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


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


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



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


validation for intended use

ALCOA


Cont

empo

rane

ous

Original

Accurate

ALCOA model



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


software designvalidation for intended

use

ALCOA


Cont

empo

rane

ous

Original

Accurate

ALCOA model



O – Original

Documentation should be performed on original records

Paper Electronic

no scratches no copies of electronic records can be made


software designvalidation for intended

use

ALCOA


Cont

empo

rane

ous

Original

Accurate

ALCOA model



A – Accurate

Records should be honest and thorough

Paper Electronic

witness checks technical controls on input fields

reason of change all changes are reviewed


audit trail reviewvalidation for intended

use

ALCOA


Cont

empo

rane

ous

Original

Accurate

automatic or

systematic

Audit trail review


“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




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




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


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



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



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


• 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.

19 | © 2016 pi

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References


• 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

http://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11&showFR=1





http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm125125.pdf

http://www.fda.gov/OHRMS/DOCKETS/98fr/04d-0440-gdl0002.pdf

http://ec.europa.eu/health/files/eudralex/vol-4/annex11_01-2011_en.pdf

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/412735/Data_integrity_definitions_and_guidance_v2.pdf

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/412735/Data_integrity_definitions_and_guidance_v2.pdf

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm495891.pdf

http://www.who.int/medicines/publications/pharmprep/WHO_TRS_996_annex05.pdf?ua=1

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/538871/MHRA_GxP_data_integrity_consultation.pdf

https://www.picscheme.org/useruploads/documents/PI_041_1_Draft_2_Guidance_on_Data_Integrity_2.pdf

Data Integrity webinar - Essentials & Solutions

Healthcare

Transcript of Data Integrity webinar - Essentials & Solutions