Using LIMS to Drive Data Integrity in a Regulated Environment...Direct Connections Data Systems...

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Using LIMS to Drive Data Integrity in a Regulated EnvironmentDr David HardyTechnical Solutions ManagerDigital Sciences

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Data Integrity Definitions

Data Integrity: The degree to which a collection of data is complete,

consistent and accurate.FDA Glossary of Computer Systems Software

Development Terminology (1995)

Data Integrity: The extent to which all data is complete, consistent and

accurate throughout the data lifecycle. MHRA Guidance for Industry on Data Integrity

2015

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Why is Data Integrity Important?

Consider the Consequences

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Data Integrity is a Major Regulatory IssueGlobal issue but what are the causes?

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Data Integrity is a Major Regulatory IssueGood Intentions – Soon Overwhelmed

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ALCOA+

Attributable — Who performed an action & when?

Legible — Can you read the data file & written entries throughout the life cycle?

Contemporaneous —Documented at the time of the activity.

Original — Original record or a certified copy.

Accurate — No errors or editing without documented amendments.

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ALCOA+

Complete - All data including any test, repeat or reanalysis performed

Consistent - All elements of the analysis such as the sequence of events follow on and are date or time stamped in the expected sequence

Enduring - Recorded in laboratory notebooks or in validated systems

Available - Can be accessed for review and audit or inspection over the lifetime of the record

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Regulated Environments

The world leader in serving science

Data Integrity - What’s the Solution?

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Informatics Aids Data Integrity Compliance

Lab Management

Complete Laboratory Management

Sample, test, & result management

Management of lab personnel & resources

Process optimization & standardization

LIMS

Data Visualization

Visualize without original application

Laboratory data archival, retrieval and preservation

Support for >180 instrument data formats

Vendor independent XML for long term storage

Raw Data

Procedural ExecutionDrives users through a process

in a stepwise fashion

Configuration, not customization to deploy methods and SOPs

Connects to the general LIMS capabilities to provide an

integrated solution

Laboratory Execution

Methods & SOPs

Thermo Fisher Scientific SampleManager LIMS provides a complete picture of your laboratory data from the original raw data to final results

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Data Integrity Issue: Adhere to Your SOP

Maps your SOP’s (methods) electronically to

aid execution and compliance

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Data Integrity Issue: Adhere to Your SOP

Background information and prerequisites are shown before starting

the execution

Lab Execution details can be added

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Instrument Selection

Instructions per step

Different prompts per step

Step wise approach

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Drift Check Result Entry

Result Entry, manual or from an

instrument

Limit checks done during execution, includes MLP

checking

Hazard signs shown during execution

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Calculations and Final Result

eSignature configuration per step

Calculations done (using values from

previous steps)

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Review Execution

Review by exception

Accept or Reject steps or overall execution

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Data Integrity Issue: Unofficial Testing

Automate your laboratory decisions and improve your ability to respond to the needs of your business

Graphically define your lab process in the system

SampleManager LIMS manages the complete laboratory workflow ensuring testing procedures are followed correctly

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SampleManager SDMS provides secure, future-proofed data archival & management.

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Data Integrity Issue: Lack of Complete, Lost or Deleted Data

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Data Integrity Issue: Lack of Complete, Lost or Deleted Data -SDMS Solution

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Data Integrity Issue: Failure to Sign/Approve Tests or Reports

SampleLogin

TestAssignment

ResultEntry

ResultApproval

(Supervisor)

TestApproval(Manager)

Batch/SampleApproval

(QA)

SampleReceipt

e CoA

ERP

Instrument Data

Capture

Labels

ScanSample

View ProceduresOperator Approval Control

Instrument Calibration ControlStock Not Expired & Usage

Control

ViewInstrument Data

OOS

ERP

Lot DispositionBatch Records Update

LIMS manages the complete review and approval process to ensure correct sign off has occurred

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Data Integrity Issue: Access to Data via the Operating System

Data Systems (CDS, MS, FT/IR, etc.)Data Systems (CDS, MS, FT/IR, etc.)Direct ConnectionsDirect Connections

MESERPPLM DMS

LES

SDMSLIMS

•All data is stored securely in a database

•Checksums to ensure signed data is unaltered

• Information directly from data systems

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• Concurrent user licensing eliminates any business benefit of shared user entities

• User Security manages Roles, Groups and Users to ensure appropriate privileges and security are maintained for each user

• Ensure that the data managed by CROs and other agencies is also appropriately managed

Data Integrity Issue: Shared User Identities

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Data Integrity Issue: Lack of Training in Data Integrity

Training Records can be managed within SampleManager LIMS ensuring that all training is up to date

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Thank you and any questions?