Pragmatic Approach To Achieve Data Integrity & Compliance

Pragmatic Approach To Achieve

Data Integrity & Compliance

Presented by “Mukunth Venkatesan, CEO, Agaram Technologies

Mukunth Venkatesan started his career as a bio-medical instrumentation engineer.

He joined Agaram group 26 years back to lead the analytical instrumentation and R&D division for manufacturing HPLCs in India.

Mukunth moved on to establish a software development team for instrumentation. Once he cut his teeth in instrument software development, the next logical step was to start developing “Laboratory Informatics” software.

Agaram Technologies today is a well-established “Laboratory Informatics” player having implemented its Qualis© LIMS, Logilab ELN©, Logilab SDMS© and Qualis© DMS suite of products at a host of Pharmaceutical and Life Sciences laboratories across the globe.

CEO, Agaram Technologies

Mukunth Venkatesan

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[email protected]

Available

Linking data to a source

along with metadata,

person & process

Legible

Data stored

electronically is

legible

Contemporaneous

System to record as &

when an activity is

performed with date &

time stamp

Original & True Copy

Original data along with

metadata verified &

signed by competent

person

Recalling ALCOA & What to Achieve

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Accurate

Data captured directly

without human

intervention with cross

checking mechanism

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Automation Architecture Model for Data Integrity Assurance

Audit trail of all activities

Server based date/time stamping of

Contemporaneous activities

Audit trail of client side activities

creation, modification, deletion,

renaming etc.

Automatic storage of original & meta

data generated in a controlled

environment (server)

Attributable to source (instrument & person)

Legible (electronic storage)

An environment for controlled access to

system or application

Attributable to source (instrument/software

& person)

Users should be able to continue to work

on data

Contemporaneous recording (LIMS, ELN)

Modify (method or reprocess or update) e.g.

CDS, Documents

Modified data to be automatically versioned

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Basic Functional Requirements for Data Integrity

Review & approval

Check single source of truth

(Original /True copy)

cGMP data outcome (Result)

Should be taken from the server

data – Single source of Truth

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Basic Functional Requirements for Data Integrity

How and where is original data created and what to

do with data?

• Data is created by users and instruments in local/network drives

• Automation should store a “True copy” in the server (controlled area)

Risk & Mitigation at Data Generation & Recording stage

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How do you ensure that the data is complete, accurate and

traceable to meet ALCOA? Automation should ensure

• A (who, which instrument, why, what purpose

• L (Electronic copy should be legible & longevity)

• C (contemporaneous as & when created/modified)

• O (original copy to be saved and verifiable)

• A (Automatic capture without human intervention)

Is it possible to recreate, amend or delete

original data and metadata?

• Automation should help in identifying amendments & version data automatically

• “NO” possibility to delete or obscure data

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How data is transferred to other locations or

systems for processing or storage?• Automation should help in download/restore of

data in a controlled manner for processing or storage

• Any change due to processing to be handled by automation system with version control

Risk & Mitigation at Data Generation & Recording stage

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How is Meta data handled?

• Method used for processing to be identified as metadata for capture

• When no external metadata is available • Raw data should contain relevant metadata • Else manually record metadata

How is impact of data processing handled?

• Any change to data due to processing should always be captured by the automation system (version control)

Risk & Mitigation at Data Accessing & Processing stage

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Does the person processing the data have the ability to

influence what data is reported?

• Person should not have any control over raw data generated

• Even if a person does trials, all such trials should be captured

independently along with version control

• Automation server should be “single source truth” with all

versions.

• Reporting of specific version of data should be a scientific and

informed decision.

Risk & Mitigation at Data Accessing & Processing stage

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Risk & Mitigation of Completeness, Accuracy of reported data

Is data original (including the original data format) available

for checking?

• Always original format data should be available at server

• Accuracy of reported data can be cross checked based on

original data for data integrity

• Electronic integration eliminates manual intervention and

improves integrity AL

C

OA

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Does the data reviewer have visibility and access to all data

generated & processed?

• Reviewer can check all versions of data generated from

single source of truth (server) without having to look at

disparate systems.

• Download and re-creation of output using the original

application helps in cross checking

Risk & Mitigation of Completeness, Accuracy of reported data

AL

C

OA

Prevention is better than

cure – both FDA and

MHRA recommend this

Approach

“Use of external devices or

system interfacing methods

that eliminate manual data

entries and human interaction

with the computerised

system”

Workshop will cover how to

achieve data integrity for:

• Instrument raw & meta data

(standalone & PC controlled)

• non-CFR compliant instruments

• Documents (MS-Office)

• Controlled blank form issuance

(e.g. cGMP record, data sheets, BMR,

Deviations etc.)Automation will be key to

achieve data integrity

Solutions designed to meet

ALCOA & 21 CFR Part 11

Pragmatic Approach for Data Integrity

www.agaramtech.com13

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Instrument Raw & Meta data

Standalone & PC-Based Instruments

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Instrument Data Capture Architecture

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Data Lifecycle

Data Integrity Protected through Capture-Compliance-Risk Intelligence-Archival

Connect Capture Review Approve

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Automated Raw Data Capture

Instrument Raw-data

Source

Capture Scheduler

Task

Upload Service

File Server Storage

FTP Service

Scheduler

Agent

Review Instrument Data

Print Report using LogiLAB PDF Printer

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Human Readable data in PDF

Print Report in PDF

• Link raw-data & metadata using tags• Create user defined tags & hierarchy

Tags: Sample ID, Batch#, Test, Product CodeHierarchy

Product>Batch>Test>Instrument>ResultProject>Trial>Test>Instrument> Result

• Tags can be entered by users• Search data based on tags

Metadata tagging for

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Standalone instruments – Mobile based tagging

• Use Mobile Device for

• Locking Instruments

• Setting Tags

• Viewing Data Captured

• Switching Instruments

• Confirm Data Captured

• View Data on the move

• Comply with data integrity

• Achieve Contemporaneous recording

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Handling Non-CFR Compliant Instruments

Data Integrity & 21 CFR Part 11 Compliance

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CFR Application Gateway

• Controlled access for non-compliant instrument software systems

• Publish applications through Gateway• Access applications based on rights• Audit Trial of User events• Automatic capture of Instrument files• Gateway controls desktop, apps,

folder & files including• Restricts

copy/paste/delete/rename/ modification

• Comply with 21 CFR part 11 and Data integrity guidelines

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Human Generated Documents

MS-Office Documents and cGMP records

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Documents & cGMP records

Protect applications like Excel, Word and any other application

• Application Access• Data modification

monitoring• Automated versioning• Audit trail for versioning• Deletion• Renaming

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Fillable Form Issuance & Print Control

Controlled Documents, Form, filling, Issuance with Print Control

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Fillable Documents Issuance

Manage Fillable forms• Creation• Editing• Review & Approval

Fillable forms• Request• Filling Meta data• Issue• Print control (Manual recording)• Electronic Recording

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Automation Solution Options

Scientific Data Management System (SDMS) Electronic Lab Notebook (ELN)

Document Management System (DMS)

Electronic Review & Approval

Automatic data version control

Control over generated & processed data

System access control with audit trail

Instrument & Human generated data

Scientific Data Management System (SDMS)

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Audit trail & Electronic Review

Contemporaneous recording with Data Versioning

Direct instrument to worksheet (no human interference)

Deploy in QC (Worksheet) & Production (BMR)

Template based data capture

Electronic Lab Notebook (ELN)

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Print Control

PDF Document with Electronic signature

Controlled entry of cGMP records (batch#, Lot#)

Document Request & Issuance

Manage organisation wide

• Documents / Forms Preparation

• Review, Approval & Release

Electronic Document Management & Issuance control

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Let’s Discuss!!!

Thank You!!!